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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, Bionpharma Inc, Indoco, Micro Labs, Mylan, and Bristol Myers Squibb, and is included in six 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-six patent family members in forty-two countries.
There are thirty drug master file entries for apixaban. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for apixaban
International Patents: | 166 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 30 |
Suppliers / Packagers: | 7 |
Bulk Api Vendors: | 109 |
Clinical Trials: | 174 |
Patent Applications: | 4,214 |
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 |
---|---|
Dt&Sanomedics | Phase 2 |
Korea University Guro Hospital | Phase 2 |
Cambridge University Hospitals NHS Foundation Trust (joint Sponsor) | Phase 3 |
Generic filers with tentative approvals for APIXABAN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5MG | TABLET; ORAL |
Start Trial | Start Trial | 2.5MG | TABLET; ORAL |
Start Trial | Start 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Indoco | APIXABAN | apixaban | TABLET;ORAL | 209898-002 | Sep 11, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
Mylan | APIXABAN | apixaban | TABLET;ORAL | 210128-001 | Dec 23, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Indoco | APIXABAN | apixaban | TABLET;ORAL | 209898-001 | Sep 11, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Accord Hlthcare | APIXABAN | apixaban | TABLET;ORAL | 210180-002 | Jul 28, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start 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 | 202155-002 | Dec 28, 2012 | Start Trial | Start Trial |
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for apixaban
Country | Patent Number | Estimated Expiration |
---|---|---|
South Korea | 101796300 | Start Trial |
Hong Kong | 1180248 | Start Trial |
Serbia | 20040227 | Start Trial |
Portugal | 1427415 | Start Trial |
Japan | 4249621 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for apixaban
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1427415 | 31/2011 | Austria | Start Trial | PRODUCT NAME: APIXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/691/001-005 (MITTEILUNG) 20110520 |
1427415 | PA2011012 | Lithuania | Start Trial | PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518 |
1427415 | 2011C/034 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE |
1427415 | 115 5011-2011 | Slovakia | Start Trial | OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH |
1427415 | 443 | Finland | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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