apixaban · Bristol Myers Squibb · NDA 202155

Eliquis

Earliest generic entry, as listed · earliest of 3 marketed strengths

24 Aug 2031

Blocked by patent: US 9326945 (pediatric extension).

Listed patents · 2 unexpired

14 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 9326945	drug product	24 Aug 2031	2 listing rows
US 9326945 listing row	drug product	24 Feb 2031	3 strengths · listed 26 May 2016
US 9326945 listing row	pediatric extension · sets the listed date	24 Aug 2031	3 strengths
US 6967208	drug substance, drug product, use U-1167, U-1200, U-1301, U-1302, U-1323, U-1501, U-1502, U-1729, U-1730, U-4178, U-4179	21 May 2027	12 listing rows
US 6967208 listing row	drug substance, drug product, use U-1167	21 Nov 2026	listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1200	21 Nov 2026	2 strengths · listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1301	21 Nov 2026	2 strengths · listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1302	21 Nov 2026	2 strengths · listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1323	21 Nov 2026	2 strengths · listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1501	21 Nov 2026	listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1502	21 Nov 2026	listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1729	21 Nov 2026	listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-1730	21 Nov 2026	listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-4178	21 Nov 2026	2 strengths · listed 25 Jan 2013
US 6967208 listing row	drug substance, drug product, use U-4179	21 Nov 2026	listed 16 May 2025
US 6967208 listing row	pediatric extension	21 May 2027	3 strengths

Exclusivities · 3 unexpired

PED	pediatric (6 months added)	17 Oct 2028
NPP	new patient population	17 Apr 2028
NS	new strength	17 Apr 2028

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

Generic tentatively approved · ANDA 210142, Teva Pharms Usa Inc · 202155-001Tentative approval 19 Oct 2026Detected 25 Oct 2026Historical import

Products covered · 3

NDA · product	Form	Strength	Approved	Listed expiry
202155 · 001 · RLD	tablet, oral	2.5MG	28 Dec 2012	24 Aug 2031
202155 · 002 · RLD	tablet, oral	5MG	28 Dec 2012	24 Aug 2031
202155 · 003 · RLD	tablet, for suspension, oral	0.5MG	17 Apr 2025	24 Aug 2031