APIXABAN - Generic Drug Details

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, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Indoco, Micro Labs, Mylan, Zydus Pharms, and Bristol Myers Squibb, and is included in eleven 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 seventy-one patent family members in forty-two countries.

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

Summary for APIXABAN

International Patents:	171
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	211
Patent Applications:	4,507
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
Centre Hospitalier Universitaire Vaudois	Phase 2
Imperial College London	Phase 4
Janssen Research & Development, LLC	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

Anatomical Therapeutic Chemical (ATC) Classes for APIXABAN

B01AF	Direct factor Xa inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-002	Sep 11, 2020	AB	RX	No	No
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-002	Dec 23, 2019		DISCN	No	No
Breckenridge	APIXABAN	apixaban	TABLET;ORAL	209845-001	Jul 26, 2021		DISCN	No	No
Hetero Labs Ltd V	APIXABAN	apixaban	TABLET;ORAL	210066-001	Nov 21, 2023	AB	RX	No	No
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-001	Dec 28, 2012	AB	RX	Yes	No			Y
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-001	Sep 11, 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	202155-001	Dec 28, 2012
Bristol Myers Squibb	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012

EU/EMA Drug Approvals for APIXABAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb / Pfizer EEIG	Eliquis	apixaban	EMEA/H/C/002148 For Eliquis 2.5 mg film-coated tablets:Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).For Eliquis 5 mg film-coated tablets:Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	no	no	no	2011-05-18
Accord Healthcare S.L.U.	Apixaban Accord	apixaban	EMEA/H/C/005358 Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).	Authorised	yes	no	no	2020-07-23

International Patents for APIXABAN

Country	Patent Number	Title	Estimated Expiration
Serbia	59576	FORMULACIJE APIKSABANA (APIXABAN FORMULATIONS)
Slovenia	3246021
Portugal	3017811
Spain	2758031
Russian Federation	2004112191
Japan	2013521226

Supplementary Protection Certificates for APIXABAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	122011100050	Germany		PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	31/2011	Austria		PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520
1427415	115 5011-2011	Slovakia		OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH
1427415	C01427415/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1427415	443	Finland
1427415	11C0042	France		PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520