Table. Biosimilars With Litigated Ancillary Product Patentsa.
| Branded drug name (generic name) | Primary patent (expiration date)b | FDA approval date | Litigated ancillary product patent (expiration date)c | Extension of time, dd | Ancillary product claim subject matter |
|---|---|---|---|---|---|
| Epogen/Procrit (epoetin alfa) | US 5 547 933 (Aug 20, 2013) | Jun 1, 1989 | US 5 856 298 (Jan 5, 2016) | 868 | Silylation profile |
| Eylea (aflibercept) | US 7 070 959 (Jun 16, 2023) | Nov 18, 2011 | US 11 186 625 (Aug 18, 2040) US 11 306 135 (Aug 18, 2040) US 11 066 458 (Jun 14, 2027) US 10 464 992 (Jun 14, 2027) |
6273 | Oxidation profile Oxidation profile Glycosylation profile Aggregation profile |
| Herceptin (trastuzumab) | US 5 821 337 (Oct 13, 2015) | Sep 25, 1998 | US 6 339 142 (May 3, 2019) US 9 249 218 (May 3, 2019) |
1298 | Acidic profile Acidic profile |
| Humira (adalimumab) | US 6 090 382 (Dec 31, 2016) | Dec 31, 2002 | US 8 916 153 (Nov 14, 2034) US 9 550 826 (Nov 14, 2034) US 9 181 337 (Nov 12, 2033) US 9 200 070 (Nov 12, 2033) US 9 505 833 (Nov 12, 2033) US 9 085 618 (Nov 12, 2033) US 9 522 953 (Nov 12, 2033) US 9 334 319 (Mar 14, 2033) US 9 683 033 (Mar 14, 2033) US 9 708 400 (Mar 14, 2033) US 9 365 645 (Apr 26, 2032) US 9 255 143 (Apr 26, 2032) US 8 231 876 (Apr 4, 2027) US 8 895 009 (Apr 4, 2027) US 9 096 666 (Apr 4, 2027) |
6527 | Purity level Glycosylation profile Lysine species Acidic profile Methylglyoxal species Acidic profile Acidic profile Acidic profile Acidic profile Lysine species Fucosylation profile Fucosylation profile Purity level Purity level Purity level |
| Avastin (bevacizumab) | US 6 407 213 (Jun 20, 2020) US 6 054 297 (Feb 26, 2018)e |
Feb 26, 2004 | |||
| Enbrel (etanercept) | US 8 163 522 (Apr 24, 2029) RE 36 755 (Oct 23, 2012)e |
Nov 2, 1998 | |||
| Neulasta (pegfilgrastim) | US 5 824 784 (Oct 20, 2015) | Jan 31, 2002 | |||
| Neupogen (filgrastim) | US 5 580 755 (Dec 3, 2013) | Feb 20, 1991 | |||
| Remicade (infliximab) | US 6 284 471 (Sep 4, 2018) | Aug 24, 1998 | |||
| Rituxan (rituximab) | US 5 736 137 (Apr 7, 2015) US 5 677 180 (Oct 14, 2014) |
Nov 26, 1997 | |||
| Stelara (ustekinumab) | US 6 902 734 (Sep 25, 2023)e | Sep 25, 2009 | |||
| Tysabri (natalizumab) | US 5 840 299 (Apr 27, 2017)e US 6 602 503 (Aug 5, 2020) |
Nov 23, 2004 |
Abbreviation: FDA, Food and Drug Administration.
We identified all patents litigated against biosimilars identified by reviewing all complaints filed in federal court by branded drug companies alleging patent infringement against biosimilar manufacturers. The independent claims of all litigated patents were reviewed.
Primary product patents were identified as the first product patent to disclose the active ingredient of the biologic drug.
Ancillary product patents were identified as having a later effective filing date and expiry date than the primary product patent and including at least 1 physiochemical property of the drug.
Extension of time was determined by subtracting the last-to-expire ancillary product patent’s expiration date from the primary patent’s expiration date.
Patent is associated with patent term extension.