Table 1. Examples of FDA new drug approvals from 1986 to 2014 brought to market with new chemical entity exclusivity but either (i) no patents listed in the FDA Orange Book, or (ii) listed patents expiring prior to new chemical entity exclusivity.
The priority review eligibility and orphan drug status of each drug are also indicated. Source: Lietzan, E. The Myths of Data Exclusivity. Lewis Clark Law Rev. 20, 91–164 (2016).
| Year of
Approval |
Drug | Indication | Priority Review
Granted (‘Significant Improvement’ Over Standard of Care) |
Concurrent
Orphan Drug Exclusivity |
Orange Book
Listed Patent (Expiry) |
|---|---|---|---|---|---|
| 1986 | Provocholine (methacholine chloride) | Diagnosis of bronchial airway hyper-reactivity in patients who do not
have clinically apparent asthma |
+ | ||
| 1987 | Levatol (penbutolol sulfate) | Mild to moderate arterial hypertension | |||
| 1989 | Anafranil (clomipramine hydrochloride) | Obsessive-compulsive disorder | + | ||
| 1989 | Optipranolol (metipranolol hydrochloride) | Open-angle glaucoma and other causes of ocular high pressure | |||
| 1989 | Lariam (mefloquine hydrochloride) | Mild to moderate acute malaria | + | ||
| 1989 | Clorazil (clozapine) | Severely ill schizophrenic patients | + | ||
| 1990 | Hexalen (altretamine) | Refractory ovarian cancer | + | + | |
| 1993 | Leustatin (cladribine) | Active hairy cell leukemia | + | + | |
| 1993 | Trasylol (aprotinin bovine) | Reduction of bleeding during complex surgery | + | + | |
| 1993 | Flumadine (rimantadine hydrochloride) | Influenza type-A infections | + | ||
| 1995 | Revex (nalmefene hydrochloride) | Partial reversal of effects of narcotics | |||
| 1996 | Proamatine (midodrine hydrochloride) | Orthostatic hypotension | + | ||
| 1997 | Normiflo (ardeparin sodium) | Prevention of blood clot formation following certain types of surgery | |||
| 1997 | Corlopam (fenoldopam mesylate) | Short-term management of hypertension | |||
| 1998 | Infasurf (calfactant) | Respiratory distress syndrome in premature infants | |||
| 1999 | Nilandron (nilutamide) | Treatment of prostate cancer in men who have undergone surgical
castration |
|||
| 1999 | Curosurf (poractant alfa) | Respiratory distress syndrome in premature infants | |||
| 2000 | Celexa (citalopram hydrobromide) | Depression | |||
| 2000 | Innohep (tinzaparin sodium) | Deep vein thrombosis | |||
| 2003 | Elestat (epinastine hydrochloride) | Prevention of itching associated with allergic conjunctivitis | |||
| 2004 | Sanctura (trospium chloride) | Overactive bladder | |||
| 2011 | Potiga (ezogabine) | Epileptic seizures | |||
| 2011 | Firazyr (icatibant) | Hereditary angioedema | + | + | + (July 2015) |
| 2011 | Ferriprox (deferiprone) | Iron overload in patients with thalassemia receiving blood transfusions | + | ||
| 2012 | Choline C 11 | PET scan imaging agent for detection of recurrent prostate cancer | |||
| 2013 | Dotarem (gadoterate meglumine) | MRI contrast agent for use in brain and spinal tissues | |||
| 2014 | Impavido (miltefosine) | Bacterial leishmaniasis | + |