cliffwatch

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.

Listed patents · 14 unexpired

PatentClaimsExpires
US 9326945—24 Aug 2031
US 9326945product24 Feb 2031
US 6967208—21 May 2027
US 6967208substance, product, use U-130221 Nov 2026
US 6967208substance, product, use U-132321 Nov 2026
US 6967208substance, product, use U-417821 Nov 2026
US 6967208substance, product, use U-150121 Nov 2026
US 6967208substance, product, use U-417921 Nov 2026
US 6967208substance, product, use U-150221 Nov 2026
US 6967208substance, product, use U-120021 Nov 2026
US 6967208substance, product, use U-172921 Nov 2026
US 6967208substance, product, use U-130121 Nov 2026
US 6967208substance, product, use U-173021 Nov 2026
US 6967208substance, product, use U-116721 Nov 2026

Exclusivities · 3 unexpired

PEDpediatric (6 months added)17 Oct 2028
NPPnew patient population17 Apr 2028
NSnew strength17 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

  • 25 Oct 2026Generic tentatively approved · 202155-001

Products covered · 3

NDA · productFormStrengthListed expiry
202155 · 001 · RLDtablet, oral2.5MG24 Aug 2031
202155 · 002 · RLDtablet, oral5MG24 Aug 2031
202155 · 003 · RLDtablet, for suspension, oral0.5MG24 Aug 2031