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.