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, 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 |
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 |
Generic filers with tentative approvals for APIXABAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 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
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Micro Labs | APIXABAN | apixaban | TABLET;ORAL | 210013-002 | Dec 23, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Breckenridge | APIXABAN | apixaban | TABLET;ORAL | 209845-001 | Jul 26, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd V | APIXABAN | apixaban | TABLET;ORAL | 210066-001 | Nov 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for apixaban
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 59576 | FORMULACIJE APIKSABANA (APIXABAN FORMULATIONS) | ⤷ Sign Up |
Slovenia | 3246021 | ⤷ Sign Up | |
Portugal | 3017811 | ⤷ Sign Up | |
Spain | 2758031 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for apixaban
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1427415 | 122011100050 | Germany | ⤷ Sign Up | PRODUCT NAME: APIXABAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 |
1427415 | 31/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520 |
1427415 | 115 5011-2011 | Slovakia | ⤷ Sign Up | OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH |
1427415 | C01427415/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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