Apixaban - Generic Drug Details
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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 |
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 |
| ⤷ Try a Trial | ⤷ Try a Trial | 5MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 2.5MG | TABLET; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | APIXABAN | apixaban | TABLET;ORAL | 210185-001 | Feb 27, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Indoco | APIXABAN | apixaban | TABLET;ORAL | 209898-001 | Sep 11, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Accord Hlthcare | APIXABAN | apixaban | TABLET;ORAL | 210180-002 | Jul 28, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | APIXABAN | apixaban | TABLET;ORAL | 210091-002 | Feb 16, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| South Korea | 101796300 | ⤷ Try a Trial | |
| Montenegro | 00384 | JEDINJENJA KOJA SADRŽE LAKTAM I NJIHOVI DERIVATI KAO INHIBITORI FAKTORA Xa (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS) | ⤷ Try a Trial |
| Mexico | PA04002526 | COMPUESTOS QUE CONTIENEN LACTAMA Y SUS DERIVADOS COMO INHIBIDORES DEL FACTOR XA. (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS.) | ⤷ Try a Trial |
| Hong Kong | 1224216 | 阿哌沙班組合物 (APIXABAN FORMULATIONS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for apixaban
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1427415 | 443 | Finland | ⤷ Try a Trial | |
| 1427415 | C20110017 00045 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011 |
| 1427415 | 91888 | Luxembourg | ⤷ Try a Trial | 91888, EXPIRES: 20260518 |
| 1427415 | PA2011012,C1427415 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005, 0110518 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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