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Bosentan - Generic Drug Details
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What are the generic drug sources for bosentan and what is the scope of freedom to operate?
Bosentan
is the generic ingredient in two branded drugs marketed by Actelion Pharms, Alembic Pharms Ltd, Alvogen Pine Brook, Amneal Pharms Co, Cipla, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Actelion Pharms Ltd, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Bosentan has twenty-eight patent family members in twenty-three countries.
There are nineteen drug master file entries for bosentan. Fourteen suppliers are listed for this compound.
Summary for bosentan
International Patents: | 28 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 13 |
NDAs: | 13 |
Drug Master File Entries: | 19 |
Suppliers / Packagers: | 14 |
Bulk Api Vendors: | 89 |
Clinical Trials: | 122 |
Patent Applications: | 6,562 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for bosentan |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bosentan |
What excipients (inactive ingredients) are in bosentan? | bosentan excipients list |
DailyMed Link: | bosentan at DailyMed |
Recent Clinical Trials for bosentan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital, Rouen | Phase 2 |
Johns Hopkins University | Phase 3 |
National Cancer Institute (NCI) | Phase 1 |
Pharmacology for bosentan
Drug Class | Endothelin Receptor Antagonist |
Mechanism of Action | Endothelin Receptor Antagonists Cytochrome P450 3A Inducers Cytochrome P450 2C9 Inducers |
US Patents and Regulatory Information for bosentan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | BOSENTAN | bosentan | TABLET;ORAL | 209324-001 | Apr 26, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Par Pharm Inc | BOSENTAN | bosentan | TABLET;ORAL | 205699-002 | Apr 26, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Natco Pharma Ltd | BOSENTAN | bosentan | TABLET;ORAL | 206987-001 | Apr 26, 2019 | 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 bosentan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Actelion Pharms Ltd | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | Start Trial | Start Trial |
Actelion Pharms Ltd | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bosentan
Country | Patent Number | Estimated Expiration |
---|---|---|
South Korea | 20080014002 | Start Trial |
Japan | 4219399 | Start Trial |
South Africa | 200710903 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for bosentan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0526708 | 0290017-3 | Sweden | Start Trial | PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228 |
0526708 | SPC/GB02/030 | United Kingdom | Start Trial | PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS |
0526708 | 02C0042 | France | Start Trial | PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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