APIXABAN Drug Patent Profile
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When do Apixaban patents expire, and when can generic versions of Apixaban launch?
Apixaban is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Indoco, Micro Labs, Mylan, and Zydus Pharms. and is included in ten NDAs.
The generic ingredient in APIXABAN is apixaban. There are thirty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the apixaban profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Apixaban
A generic version of APIXABAN was approved as apixaban by ACCORD HLTHCARE on July 28th, 2020.
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Summary 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | APIXABAN | apixaban | TABLET;ORAL | 210180-001 | Jul 28, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | APIXABAN | apixaban | TABLET;ORAL | 210128-002 | Dec 23, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bionpharma | APIXABAN | apixaban | TABLET;ORAL | 210152-001 | Apr 8, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | APIXABAN | apixaban | TABLET;ORAL | 210091-002 | Feb 16, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd V | APIXABAN | apixaban | TABLET;ORAL | 210066-002 | Nov 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | APIXABAN | apixaban | TABLET;ORAL | 210185-002 | Feb 27, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bionpharma | APIXABAN | apixaban | TABLET;ORAL | 210152-002 | Apr 8, 2020 | DISCN | 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 |
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 |
