Apixaban Orange Book Patents and Generics
What patents and exclusivities are listed in the FDA Orange Book for apixaban (Eliquis), when do they expire, and which generic ANDAs are approved?
The FDA Orange Book lists two patents for Eliquis (apixaban) tablets: US 6,967,208, which expires Nov 21, 2026, and US 9,326,945, which expires Feb 24, 2031. Each has a pediatric extension, to May 21, 2027 and Aug 24, 2031. The newest exclusivities run to Apr 17, 2028, with pediatric exclusivity to Oct 17, 2028. Thirteen generic ANDAs are approved, all for 2.5 mg and 5 mg tablets. Only two of them (Accord and Regcon) are listed as active prescription products with an AB rating; the other eleven are marked discontinued.
Approach: I searched the Orange Book products file, which lists the patents and exclusivities for each product. That file does not include use-code definitions, tentative approvals or Paragraph IV certifications, so those are not covered here.
Innovator products (Bristol Myers Squibb)
| Product | Patents (expiry) | Exclusivities |
|---|---|---|
| Eliquis 2.5 mg tablet, NDA 202155/001 (approved Dec 28, 2012; AB) | '208 expires Nov 21, 2026, listed with 10 use codes (U-1167, U-1200, U-1301, U-1302, U-1323, U-1501, U-1502, U-1729, U-1730, U-4178); '208PED May 21, 2027; '945 Feb 24, 2031; '945PED Aug 24, 2031 | NPP until Apr 17, 2028; PED until Oct 17, 2028 [1] |
| Eliquis 5 mg tablet, NDA 202155/002 (approved Dec 28, 2012; AB, Reference Standard) | '208 expires Nov 21, 2026 (U-1200, U-1301, U-1302, U-1323, U-4178); '208PED May 21, 2027; '945 Feb 24, 2031; '945PED Aug 24, 2031 | NPP until Apr 17, 2028; PED until Oct 17, 2028 [2] |
| Eliquis 0.5 mg tablet for suspension, NDA 202155/003 (approved Apr 17, 2025) | '208 expires Nov 21, 2026 (U-4179); '208PED May 21, 2027; '945 Feb 24, 2031; '945PED Aug 24, 2031 | NS until Apr 17, 2028; PED until Oct 17, 2028 [3] |
| Eliquis Sprinkle 0.15 mg for suspension, NDA 220073/001 (approved Apr 17, 2025) | '208 expires Nov 21, 2026 (U-4180); '208PED May 21, 2027; US 11,896,586 expires Nov 22, 2040 (U-4180); '586PED May 22, 2041 | NP until Apr 17, 2028; PED until Oct 17, 2028 [4] |
What this means for generic entry:
- Current tablets: For the 2.5 mg and 5 mg tablets, the compound patent and its pediatric extension end May 21, 2027. After that, the last listed barrier is the '945 patent, including its pediatric extension, to Aug 24, 2031. The NPP and PED exclusivities on these products run to April and October 2028.
- Sprinkle product: Only the Sprinkle formulation carries the '586 patent, with pediatric extension to May 22, 2041.
Approved generic ANDAs (each has 2.5 mg and 5 mg oral tablets)
| ANDA | Applicant | Approval date | Status / TE code |
|---|---|---|---|
| 210013 | Micro Labs Ltd | 2019-12-23 | Discontinued [5][6] |
| 210128 | Mylan Pharmaceuticals Inc | 2019-12-23 | Discontinued [7][8] |
| 210152 | Bionpharma Inc | 2020-04-08 | Discontinued [9][10] |
| 210180 | Accord Healthcare Inc | 2020-07-28 | Rx, AB [11][12] |
| 209898 | Regcon Holdings LLC | 2020-09-11 | Rx, AB [13][14] |
| 209845 | Breckenridge Pharmaceutical Inc | 2021-07-26 | Discontinued [15][16] |
| 210185 | Zydus Pharmaceuticals USA Inc | 2023-02-27 | Discontinued [17][18] |
| 210026 | Aurobindo Pharma Ltd | 2023-05-26 | Discontinued [19][20] |
| 210066 | Hetero Labs Ltd Unit V | 2023-11-21 | Discontinued [21][22] |
| 210091 | Apotex Inc | 2024-02-16 | Discontinued [23][24] |
| 210156 | Torrent Pharmaceuticals Ltd | 2024-12-17 | Discontinued [25][26] |
| 209810 | Impax Laboratories LLC | 2025-02-14 | Discontinued [27][28] |
| 210067 | Macleods Pharmaceuticals Ltd | 2025-02-27 | Discontinued [29][30] |
No ANDA is listed for the 0.5 mg tablet for suspension or the Sprinkle formulation.
The Orange Book shows status codes only. It does not say why the eleven ANDAs are marked discontinued or when any generic will launch. I can look for FDA shortage records or NDC listings for these generics next if that would help.