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Apixaban - Generic Drug Details

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What are the generic drug 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:	108
Clinical Trials:	171
Patent Applications:	4,011
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
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network	Phase 4

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
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012	AB	RX	Yes	Yes			Y	Y
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No			Y
Bionpharma Inc	APIXABAN	apixaban	TABLET;ORAL	210152-001	Apr 8, 2020		DISCN	No	No
Accord Hlthcare	APIXABAN	apixaban	TABLET;ORAL	210180-001	Jul 28, 2020	AB	RX	No	No
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-001	Dec 23, 2019		DISCN	No	No
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-001	Sep 11, 2020	AB	RX	No	No
Mylan	APIXABAN	apixaban	TABLET;ORAL	210128-001	Dec 23, 2019		DISCN	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	202155-001	Dec 28, 2012
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012

International Patents for apixaban

Country	Patent Number	Estimated Expiration
Malaysia	137830
Israel	203533
San Marino	T201600049
Russian Federation	2004112191
Hungary	E047139
Portugal	3017811
Colombia	5560567

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	C 2011 008	Romania		PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1427415	SPC/GB11/042	United Kingdom		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/11/691/001 20110520; UK EU/1/11/691/002 20110520; UK EU/1/11/691/003 20110520; UK EU/1/11/691/004 20110520; UK EU/1/11/691/005 20110520
1427415	CA 2011 00028	Denmark
1427415	C300500	Netherlands		PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	2011/032	Ireland		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	1190029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415	115 5011-2011	Slovakia		OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH