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Apixaban - Generic Drug Details

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What are the generic sources for apixaban and what is the scope of patent protection?

Apixaban is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Bionpharma Inc, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apixaban has one hundred and sixty-six patent family members in forty-two countries.

There are thirty drug master file entries for apixaban. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for apixaban

International Patents:	166
US Patents:	2
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	30
Suppliers / Packagers:	7
Bulk Api Vendors:	109
Clinical Trials:	174
Patent Applications:	4,214
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for apixaban
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apixaban
What excipients (inactive ingredients) are in apixaban?	apixaban excipients list
DailyMed Link:	apixaban at DailyMed

See drug sales revenues for apixaban

Recent Clinical Trials for apixaban

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dt&Sanomedics	Phase 2
Korea University Guro Hospital	Phase 2
Cambridge University Hospitals NHS Foundation Trust (joint Sponsor)	Phase 3

See all apixaban clinical trials

Generic filers with tentative approvals for APIXABAN

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		2.5MG	TABLET; ORAL
		5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for apixaban

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for APIXABAN

Tradename	Dosage	Ingredient	NDA	Submissiondate
ELIQUIS	TABLET;ORAL	apixaban	202155	2016-12-28

US Patents and Regulatory Information for apixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-002	Sep 11, 2020	AB	RX	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No			Y
Mylan	APIXABAN	apixaban	TABLET;ORAL	210128-001	Dec 23, 2019		DISCN	No	No
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-001	Sep 11, 2020	AB	RX	No	No
Accord Hlthcare	APIXABAN	apixaban	TABLET;ORAL	210180-002	Jul 28, 2020	AB	RX	No	No

Expired US Patents for apixaban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012

International Patents for apixaban

Country	Patent Number	Estimated Expiration
South Korea	101796300
Hong Kong	1180248
Serbia	20040227
Portugal	1427415
Japan	4249621

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	31/2011	Austria		PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520
1427415	PA2011012	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
1427415	115 5011-2011	Slovakia		OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
1427415	443	Finland