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, Bionpharma Inc, Breckenridge, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in seven 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 sixty-eight patent family members in forty-two countries.
There are thirty drug master file entries for apixaban. Seven suppliers are listed for this compound.
Summary for apixaban
International Patents: | 168 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 195 |
Patent Applications: | 4,817 |
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 |
---|---|
University Hospital, Geneva | Phase 3 |
Sunnybrook Health Sciences Centre | Phase 3 |
Laval University | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Bionpharma Inc | APIXABAN | apixaban | TABLET;ORAL | 210152-002 | Apr 8, 2020 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | See Plans and Pricing | See Plans and Pricing |
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for apixaban
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1427415 | COMPOSES CONTENANT DU LACTAME ET LEURS DERIVES EN TANT QU'INHIBITEURS DU FACTEUR XA (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS) | See Plans and Pricing |
Singapore | 10201501349V | APIXABAN FORMULATIONS | See Plans and Pricing |
China | 104744461 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for apixaban
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1427415 | 91888 | Luxembourg | See Plans and Pricing | 91888, EXPIRES: 20260518 |
1427415 | C 2011 008 | Romania | See Plans and Pricing | PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518 |
1427415 | 31/2011 | Austria | See Plans and Pricing | PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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