Manufacturing Supply Chains and Imports in the ADHD Drug Shortage

Janet Currie; Anna Malinovskaya

doi:10.1001/jamahealthforum.2026.0041

. 2026 Mar 20;7(3):e260041. doi: 10.1001/jamahealthforum.2026.0041

Manufacturing Supply Chains and Imports in the ADHD Drug Shortage

Janet Currie ^1,^✉, Anna Malinovskaya ¹

PMCID: PMC13005163 PMID: 41860539

Key Points

Question

What do the data reveal about the likely causes of the attention-deficit/hyperactivity disorder (ADHD) medication shortage of 2022-2023?

Findings

In this economic evaluation using time series data (2015-2025) on US production, consumption, and trade of stimulants, the most recent ADHD drug shortage coincided with a historically unprecedented decrease in US imports of the active ingredient amphetamine and a more modest decline in the imports of phenylacetone, a key precursor.

Meaning

This finding suggests that international supply chain disruptions likely contributed to recent ADHD drug shortages.

Abstract

Importance

The US has faced a nationwide shortage of attention-deficit/hyperactivity disorder (ADHD) medications since 2022, yet the underlying causes remain unclear. Public debate has largely centered on prescribing trends and Drug Enforcement Administration (DEA) quotas, although evidence suggests that quotas were not binding. A sound policy response requires a clear understanding of the drivers behind the shortage.

Objective

To examine descriptive evidence on the potential causes of the shortage.

Setting and Design

In this economic evaluation, we use time series data (2015-2025) from multiple sources, such as Symphony Health and the DEA’s Automation of Reports and Consolidated Orders System (ARCOS) summary reports, to characterize US production, consumption, and trade of amphetamine-based and other stimulants, including manufacturer-level production volumes, before and during the shortage period.

Findings

The sharp, simultaneous production cutbacks across several medium-sized and smaller manufacturers in late 2022 and early 2023 coincided with a steep contraction in US imports of raw amphetamines and more modest declines in phenylacetone, a key precursor.

Conclusions and Relevance

These patterns align with manufacturers’ reports to the US Food and Drug Administration citing a shortage of the active ingredient as the cause of backorders. More broadly, this economic evaluation reframes the discussion of ADHD medication shortages beyond DEA quotas, highlighting the vulnerability of US pharmaceutical manufacturing to international supply chain disruptions and underscoring the need for policies that strengthen supply chain resilience.

This economic evaluation examines the descriptive evidence contributing to the shortage of drugs used to treat attention-deficit/hyperactivity disorder in 2022 and 2023.

Introduction

About 15.5 million US adults had a diagnosis of attention-deficit/hyperactivity disorder (ADHD), about a third of whom took an ADHD stimulant medication in 2023.¹ Of those taking ADHD stimulant medications, more than 70% had difficulty filling their prescription.¹ The shortage of stimulant medications used to treat ADHD in 2022 and 2023 has received widespread publicity^2,3,4,5,6,7 with some commentators blaming excessive regulation and/or increases in prescribing driven by telehealth.^8,9

Stimulants are controlled substances, and the US Drug Enforcement Administration (DEA) issues manufacturers quotas capping the amounts that they can produce. The DEA also strictly monitors production and distribution of stimulants. In 2022, it took measures that led to a temporary and at least partial shutdown of one manufacturer of stimulants, citing irregular bookkeeping.¹⁰ The shortage also led Democratic members of the House Committee on Oversight and Accountability to launch an investigation into 3 specific drug shortages, including the amphetamine (Adderall) shortage that led to their sending a letter of inquiry to the largest manufacturer of the amphetamine-based stimulant.¹¹ The DEA and US Food and Drug Administration (FDA) cited 3 factors to explain the shortage: manufacturing delays affecting a single manufacturer; manufacturers collectively meeting only 70% of their production quotas; and increased demand for stimulants after the COVID-19 pandemic.¹²

This data analysis establishes several facts about the 2022-2023 ADHD drug shortage that point to different reasons for the sharp decline in retail stimulant availability in 2022 and 2023. The data show that the abrupt drop in production of amphetamine-based stimulants by multiple manufacturers on the US market coincided with a large fall in US imports of raw amphetamines in 2022, pointing to what appears to be a supply chain failure. Although this study focused primarily on amphetamine, it also considered briefly lisdexamfetamine and methylphenidate (including dexmethylphenidate) because the shortage of amphetamine-based stimulants that started in 2022 was followed by a shortage of these other 2 stimulants starting in July 2023, and because together these 3 active ingredients account for more than 90% of ADHD stimulant prescription fills and more than 80% of ADHD stimulant and nonstimulant prescription fills combined (eTable 1 in the Supplement 1 lists FDA-approved ADHD medications).^13,14

Methods

Because this study relied exclusively on publicly available data and did not constitute human subjects research, institutional review board approval was not necessary. We followed the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) reporting guidelines.

First, we plotted several times series characterizing the consumption of amphetamine-based stimulants to describe the relative severity of the most recent ADHD medication shortage, which formally started in October 2022, when the FDA announced a shortage of amphetamine salts immediate release tablets.¹⁵ It is important to place this shortage into historical context because although it received a lot of media attention, the media also mentioned an inadequate supply starting from September 2019, and research documents multiple shortages of amphetamine derivatives from 2001 through 2023.^16,17,18

Second we examined the consumption patterns for the other 2 major stimulants—lisdexamfetamine and methylphenidate—because the 3 stimulants might be substitutes to some extent, even though it is unlikely that the 3 stimulants are perfect substitutes for consumers. There are no large-scale studies, to our knowledge, on the costs and consequences of switching ADHD medications. One small-scale study showed that finding the appropriate ADHD medication takes time. In particular, it found that 41% of adults who were prescribed an ADHD medication for the first time needed to switch the medication within 90 days because of poor tolerability.¹⁹ Additionally, in one interview, several psychiatrists associated switching from a brand-name ADHD drug to a generic with inconveniences for patients, such as increased adverse effects or a perceived loss of efficacy.²⁰

Third, we confirmed that the DEA aggregate production quotas were not binding in 2022 and 2023. The DEA authorized manufacturers to use 38 418 kg of amphetamine in 2022 (that is, 38 418 kg was the allotted aggregate production quota) out of the 42 400 kg that was available for allocation among manufacturers in that year (ie, the aggregate production quota in 2022 was 42 400 kg).^14,21 We combined this information with the data on domestic retail distribution and exports of amphetamines.

Fourth, we examined production volumes by individual manufacturers of amphetamine-based stimulants around the shortage by plotting time series for total amphetamine pills dispensed. Before we considered any production interruptions at individual amphetamine-based stimulant manufacturers, we examined the degree of market concentration for amphetamine-based stimulants in the US.

Finally, having described the US market for amphetamine-based stimulants around the time of the shortage, we examined potential reasons for the production interruptions experienced simultaneously by multiple manufacturers. Multiple manufacturers cited a “shortage of the active ingredient” to the FDA as the reason that they were not able to meet the demand for their product.²² The amphetamine base can be either produced domestically or imported. The main precursor of amphetamine, phenylacetone, can also be produced domestically or imported for domestic production of amphetamine. We were able to find at least one company’s application to the DEA in the first half of 2022 asking the DEA for permission to import phenylacetone to be used in the manufacturing of amphetamine (this company does not produce finished stimulants).²³ To understand the potential implications of a drop in amphetamine imports of this scale, we plotted time series for the imports of raw amphetamines and phenylacetone.

To complete the analysis of the ADHD medication shortage, we briefly examined the market for the other 2 major stimulants—lisdexamfetamine and methylphenidate, both of which experienced shortages around July 2023.¹⁴ One feature of the lisdexamfetamine market around the shortage (eFigure 8 in Supplement 1) was that the patent for brand-name lisdexamfetamine had expired in the first quarter of 2023, although a pediatric exclusivity period extended the manufacturer’s market exclusivity through August 2023.²⁴ Thus, the lisdexamfetamine shortage in 2023 coincided with the expiration of its patent and the entry of multiple generic manufacturers.

We do not consider imports of the raw methylphenidate active ingredient because of the way that raw methylphenidate imports are recorded in trade statistics: methylphenidate should be under HS 2933.33, but that category is rather broad (heterocyclic compounds with an unfused pyridine ring) and includes, for example, fentanyl.

Data

The analyses for stimulant pills dispensed by month, active ingredient, and manufacturer in the US relied on data from Symphony Health estimates. We validated the quality of the data by comparing the total number of stimulant prescriptions with the total number of such prescriptions reported in a DEA-commissioned IQVIA report (eTable 3 in the Supplement 1).²⁵

Data on grams of the active ingredient dispensed quarterly by retail per 100 000 population came from the DEA’s Automation of Reports and Consolidated Orders System summary reports. The data on historical aggregate production quotas also came from the DEA, whereas the allotted aggregate production quotas came from publicly available DEA documents.

The US Census Bureau’s USA Trade Online²⁶ database was used for tracking imports of amphetamine and phenylacetone. Specifically, we used 2 Harmonized System (HS) codes: (1) INN codes 2921.46: amfetamine, benzfetamine, dexamfetamine, etilamfetamine, fencamfamin, lefatamine, levamfetamine, mefenorex, and phentermine; salts thereof (salts of the active ingredients in kilograms), under the HS code 29, organic chemicals; and (2) INN code 2914.31: phenylacetone (phenylpropan-2-one) (kilograms), also under the HS code 29, organic chemicals.

Data on US exports of finished dosage stimulants came from International Narcotics Control Board (INCB) technical reports. Although we were unable to validate export volumes for amphetamine, we were able to validate exports of finished dosage methylphenidate as reported in the INCB technical reports using DEA documents (Supplement 1).

There were several sources of uncertainty in the data. For example, the amphetamine imports data aggregate all amphetamines, including those that were not relevant for this study. Additionally, we were only partially able to verify that the exports data included only exports of finished dosage-form drugs (rather than combining exports of finished dosage-form drugs and the raw active ingredient). We discuss these and additional sources of uncertainty in the data in Supplement 1.

Results

Figure 1 shows the relative severity of the most recent shortage by plotting time series for total brand-name or generic amphetamine pills dispensed per month, prescriptions filled per month, and grams dispensed over retail per 100 000 population per quarter. All 3 measures show an abrupt drop starting in the second half of 2022 and reaching bottom in the first quarter of 2023: the number of amphetamine pills dispensed reverted to first-quarter 2021 levels after 2 years of fast growth, whereas amphetamine grams dispensed per 100 000 population reverted to the first-quarter 2020 levels.

Figure 2A-C further shows that some of the 2022-2023 amphetamine shortage appears to have been mitigated by individuals’ switching to another stimulant, lisdexamfetamine. This inference follows from the large spike in all of the 3 measures of demand for lisdexamfetamine shortly after the FDA announced the amphetamine shortage. The trend for the consumption of methylphenidate, however, is less pronounced ( eFigure 1 in Supplement 1). The most recent ADHD drug shortage is still pronounced but much less so when all 3 stimulants are treated as perfect substitutes and considered jointly Figure 2D and E.

We also explored geographical variation in the amphetamine shortage at the 3-digit zip code level documenting that the shortage was more severe in some areas than others. In particular, the 50th percentile percentage change in the total grams of amphetamine dispensed at the 3-digit zip code level between the first quarters of 2022 and 2023 was more than −50% in some areas, although the median was −5.42% (eFigure 2 and eTable 2 in Supplement 1).

Figure 3 shows that the amount of amphetamine that was distributed via retail in the US relative to the allotted aggregate production quota in 2022 was approximately 70%, which is consistent with reports from the DEA and FDA.^12,27 When amphetamine finished dosage exports were added to domestic retail distribution, aggregate production remained significantly below the allotted aggregate production quota in 2022 (see eFigure 3 on US exports of amphetamine over time and a note on DEA quotas for amphetamine in Supplement 1).

Market shares were computed based on the total number of pills dispensed in the first half of 2022 (panel A of eFigure 4 in Supplement 1. We also computed market shares by total prescriptions filled. Panel B of eFigure 4 in Supplement 1 shows that the results are very similar.) Just prior to the shortage, the top manufacturer held about a quarter of the market, whereas the top 3 manufacturers held almost half (48.6%) of the amphetamine-based stimulants market. Clearly, a big decrease in production at any of the 3 top manufacturers would have had a noticeable impact on the market.

Figure 4A shows the total amphetamine pills dispensed for the top 3 manufacturers and all others combined, demonstrating that it is the “all others combined” that were associated with the biggest drop in production around the shortage. Panels B through D of Figure 4B-D show the time series of pills dispensed for select manufacturers, highlighting 6 medium-sized and smaller manufacturers who experienced sharp declines in production around the time of the shortage. Some of them (Figure 4D) never restored their production levels to the preshortage period, suggesting potential market exit. Although market exit could happen for many reasons, increased competition from generics and falling generic prices could have played a role. Although we cannot establish a causal relationship, we provide descriptive evidence by plotting prices for brand-name Adderall XR, 20 mg, amphetamine-dextroamphetamine extended-release, 20 mg, and amphetamine/dextroamphetamine, 20 mg, in eFigure 5 in Supplement 1, showing that both generic and brand-name product prices fell for most of the last 10 years, although they leveled off during the shortage period.

Panel A of Figure 5 plots time series for aggregate US imports of raw amphetamines, and Panel B plots time series for aggregate US imports of phenylacetone. Both panels show a drop in 2022. In particular, US imports of amphetamines declined by 36.7% in 2022 relative to 2021, and by 21.3% relative to 2020. Imports of amphetamines were 11 042 kg in 2020, 13 920 kg in 2021, and 8685 kg in 2022. Although amphetamine imports recovered in 2023, reaching 93.7% of the 2021 level, the catch-up was slow and by July 1, 2023, only 33.2% of total 2023 amphetamine imports had been completed (eFigure 6 in Supplement 1). US imports of raw amphetamines have been growing since at least 2014, and for the last 10 years, Germany accounted for more than 85% of US imports of amphetamines, thus also being responsible for the large drop in 2022. Imports of phenylacetone, albeit less stable over time, dropped by 17.1% relative to 2021 and by 16.9% relative to 2020 (Figure 5B).

We estimated that domestic production of amphetamine API in 2021 could likely meet roughly 70% to 80% of total amphetamine API needs (see Supplement 1 for details on this calculation and the underlying assumptions). In other words, the back-of-the-envelope calculation suggested that roughly 20% to 30% of amphetamine API was likely foreign-sourced in 2021, just prior to the shortage. However, this estimate is sensitive to assumptions about manufacturers’ inventory holdings and other parameters; more precise data would be needed to quantify the US market’s reliance on foreign-sourced amphetamine API.

Panel A1 of eFigure 8 in Supplement 1 documents that in the second half of 2023, when the patent expired, production of lisdexamfetamine by the brand-name manufacturer dropped abruptly, while the production of generic lisdexamfetamine by other manufacturers jumped. However, the initial jump in the availability of generic lisdexamfetamine was also followed by an abrupt decline until the beginning of 2024. (Note that the DEA raised the lisdexamfetamine production quota for 2024.²⁸) The shortage of the active ingredient could have potentially contributed to this temporary drop in generic lisdexamfetamine production. Panel A2 of eFigure 8 in Supplement 1 shows that while some of the top 3 generic manufacturers of lisdexamfetamine (by market share of pills dispensed in July-December 2023) exhibited what looks like an unstable production pattern, the overall decline was driven mostly by smaller manufacturers and not by the maker of Vyvanse. Panel A3 of eFigure 8 in Supplement 1 shows a simultaneous drop in production by 3 medium-sized manufacturers, suggesting that these manufacturers could have experienced a shortage of the active ingredient.

However, the evidence of active ingredient shortages is much less pronounced for methylphenidate. Panel A4 of eFigure 8 in Supplement 1 shows total pills dispensed for the top 5 manufacturers of methylphenidate by market share. Although manufacturers 1 and 3 reduced production around the amphetamine drug shortage, manufacturer 4 raised production. Additionally, although there was a temporary decrease in the aggregate number of methylphenidate pills dispensed around July 2023, this decline does not stand out when the longer time series of methylphenidate pills dispensed is considered.

Discussion

The available data suggested that, although there was increased demand for stimulants after the pandemic, manufacturers collectively had sufficient quota to raise production. At the same time, the most recent ADHD drug shortage coincided with an unprecedented decline in US imports of the active ingredient, amphetamine, following years of sustained growth in these imports. Therefore, it is likely that the abrupt drop in US imports of the active ingredient and the simultaneous but modest drop in the imports of its precursor in 2022, rather than DEA quotas, made it impossible for at least some manufacturers to meet demand. This conclusion is consistent with multiple manufacturers’ publicly referring to a shortage of the active ingredient as the reason for back-orders during the shortage.^22,29 It is also consistent with the fact that it is not easy to change API suppliers; drug manufacturers must use the API suppliers they listed on their applications to the FDA,³⁰ which could have created additional friction during the shortage.

Much of the discussion surrounding US dependence on imported APIs has so far focused on a concerning reliance on China and India.^31,32 This emphasis is not surprising: one recent study found that China—often classified as a nonpartner country—accounted for more than 60% of the total imported volume of antibiotic APIs between 2020 and 2024,³³ whereas another reported that approximately 62% of generic APIs on the US market in 2020 and 2021 (by count) were produced in India and 22% in China.³⁴ One nonpeer-reviewed study analyzed API trade in dollars rather than volumes or counts and found that 54% of APIs in US-consumed medicines in 2019 were made in the US.³⁵ The present analysis, however, highlights a supply chain disruption that appears to be originating in a European Union country. This finding suggests that supply chain vulnerability may lie not only in whether APIs are sourced from partner vs nonpartner countries but also in the degree of concentration among facilities producing each API for the US market and the independence of their precursor suppliers. Indeed, one study found that 33.7% of generic APIs for the US market in 2020 and 2021 were produced by a single facility, and another 30.4% by only 2 or 3 facilities.³⁴ Using the FDA’s Generic Drug User Fee Amendments (GDUFA) facility database, we identified 29 facilities in Germany that produced APIs for the US market in 2021 and 30 in 2022. However, how many of these facilities manufactured the amphetamine API specifically or whether they sourced their precursors independently remains unknown. Future research should aim to identify APIs supplied to the US market—whether they are produced domestically or abroad—by fewer than 4 or 5 facilities because these may represent the most vulnerable points in the pharmaceutical supply chain, regardless of the API country of origin.

Limitations

There are several limitations to the study. First, the main limitation is that it does not establish a causal relationship between the ADHD drug shortage and either a drop in amphetamine or phenylacetone imports or individual manufacturers exiting the market. Data on individual manufacturers’ transactions in the market for raw amphetamine would be needed to definitively link the disruption in amphetamine imports with output declines for individual manufacturers. Nevertheless, this study provides descriptive evidence suggesting potential reasons for the shortage that deserve further research. Second, we do not consider individual manufacturers’ quotas because these data are lacking. Information on individual manufacturers’ quotas would be helpful for understanding the fluctuations in individual manufacturers’ production that was documented in this study. Third, this study did not analyze nonstimulant ADHD mediations or antidepressants used for the treatment of ADHD off label (nonstimulant ADHD medications make up about 12% to 15% of prescription fills for FDA-approved ADHD medications,¹³ and antidepressants are usually not considered to be a first-line treatment for ADHD because they are not approved by the FDA for this purpose). Fourth, there are several sources of uncertainty in the data, especially regarding imports and exports, which are discussed in detail in Supplement 1.

Conclusions

Supply chain disruptions can occur in many places in the supply chain.³⁶ However, descriptive evidence indicates that the most recent ADHD drug shortage may be associated with a disruption in the sourcing of raw ingredients from abroad. Therefore, one way to strengthen drug supply chains is for the FDA to require drug manufacturers to submit detailed information on the suppliers used in producing each drug product, including API suppliers. This would enable the FDA to identify and monitor supply-chain vulnerabilities arising from disruptions at API manufacturers. The agency could also require site master files for drug and API manufacturing facilities, including those located abroad, to improve facility-level risk assessment. Both policy proposals have been suggested in a recent Department of Health and Human Services white paper.³⁷ Finally, the FDA could consider making it easier for drug manufacturers to change their API suppliers when a supply chain disruption occurs.

Supplement 1.

eTable 1. ADHD medications by type and class

eTable 2. Geographic variation in the severity of the 2022-2023 ADHD drug shortage, at the three-digit zip code

eTable 3. Comparison of total stimulant prescriptions filled in Symphony Health and IQVIA data

eFigure 1. Pills dispensed, prescriptions filled, and grams of active ingredient dispensed for methylphenidate

eFigure 2. Geographic variation in the severity of the 2022-2023 ADHD drug shortage, at the three-digit zip code

eFigure 3. US annual exports of amphetamine and d-amphetamine

eFigure 4. Market shares of amphetamine (brand-name and generic) in the first half of 2022 level

eFigure 5. Real price of amphetamine-based stimulants

eFigure 6. U.S. monthly imports of raw amphetamines

eFigure 7. Lisdexamfetamine and methylphenidate: annual aggregate retail distribution and exports vs. annual aggregate production quotas

eFigure 8. Total lisdexamfetamine and methylphenidate (brand name or generic) pills dispensed by manufacturer

eReferences

jamahealthforum-e260041-s001.pdf^{(3MB, pdf)}

Supplement 2.

Data Sharing Statement

jamahealthforum-e260041-s002.pdf^{(18.2KB, pdf)}

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

eTable 1. ADHD medications by type and class

eTable 2. Geographic variation in the severity of the 2022-2023 ADHD drug shortage, at the three-digit zip code

eTable 3. Comparison of total stimulant prescriptions filled in Symphony Health and IQVIA data

eFigure 1. Pills dispensed, prescriptions filled, and grams of active ingredient dispensed for methylphenidate

eFigure 2. Geographic variation in the severity of the 2022-2023 ADHD drug shortage, at the three-digit zip code

eFigure 3. US annual exports of amphetamine and d-amphetamine

eFigure 4. Market shares of amphetamine (brand-name and generic) in the first half of 2022 level

eFigure 5. Real price of amphetamine-based stimulants

eFigure 6. U.S. monthly imports of raw amphetamines

eFigure 7. Lisdexamfetamine and methylphenidate: annual aggregate retail distribution and exports vs. annual aggregate production quotas

eFigure 8. Total lisdexamfetamine and methylphenidate (brand name or generic) pills dispensed by manufacturer

eReferences

jamahealthforum-e260041-s001.pdf^{(3MB, pdf)}

Supplement 2.

Data Sharing Statement

jamahealthforum-e260041-s002.pdf^{(18.2KB, pdf)}

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PERMALINK

Manufacturing Supply Chains and Imports in the ADHD Drug Shortage

Janet Currie, PhD

Anna Malinovskaya, PhD