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, 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 patent family members in forty-two countries.

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

Summary for apixaban

International Patents:	170
US Patents:	2
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	210
Patent Applications:	4,870
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
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

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
Accord Hlthcare	APIXABAN	apixaban	TABLET;ORAL	210180-001	Jul 28, 2020	AB	RX	No	No
Hetero Labs Ltd V	APIXABAN	apixaban	TABLET;ORAL	210066-002	Nov 21, 2023	AB	RX	No	No
Zydus Pharms	APIXABAN	apixaban	TABLET;ORAL	210185-002	Feb 27, 2023		DISCN	No	No
Indoco	APIXABAN	apixaban	TABLET;ORAL	209898-002	Sep 11, 2020	AB	RX	No	No
Micro Labs	APIXABAN	apixaban	TABLET;ORAL	210013-001	Dec 23, 2019		DISCN	No	No
Mylan	APIXABAN	apixaban	TABLET;ORAL	210128-002	Dec 23, 2019		DISCN	No	No
Aurobindo Pharma Ltd	APIXABAN	apixaban	TABLET;ORAL	210026-002	May 26, 2023		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

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
Norway	20041163
Japan	2005507889
Serbia	58699	FORMULACIJE APIKSABANA (APIXABAN FORMULATIONS)
Poland	204263
China	102770126	Apixaban formulations
Hungary	E047139
Peru	20210468	FORMULACIONES DE APIXABAN

Supplementary Protection Certificates for apixaban

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	122011100050	Germany		PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
1427415	PA2011012	Lithuania		PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
1427415	1190029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415	31/2011	Austria		PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520