Apixaban - Generic Drug Details

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, Breckenridge, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in seven 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-eight patent family members in forty-two countries.

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

Summary for apixaban

International Patents:	168
US Patents:	2
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	195
Patent Applications:	4,817
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
University Hospital, Geneva	Phase 3
Sunnybrook Health Sciences Centre	Phase 3
Laval University	Phase 2

See all apixaban clinical trials

Pharmacology for apixaban

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

Paragraph IV (Patent) Challenges for APIXABAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELIQUIS	Tablets	apixaban	2.5 mg and 5 mg	202155	25	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
Bionpharma Inc	APIXABAN	apixaban	TABLET;ORAL	210152-002	Apr 8, 2020		DISCN	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No			Y

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	Title	Estimated Expiration
European Patent Office	1427415	COMPOSES CONTENANT DU LACTAME ET LEURS DERIVES EN TANT QU'INHIBITEURS DU FACTEUR XA (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS)
Singapore	10201501349V	APIXABAN FORMULATIONS
China	104744461

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	91888	Luxembourg		91888, EXPIRES: 20260518
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	31/2011	Austria		PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520