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TRACLEER Drug Profile
» See Plans and Pricing
When do Tracleer patents expire, and when can generic versions of Tracleer launch?
Tracleer is a drug marketed by Actelion Pharms and Actelion Pharms Ltd and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-eight patent family members in twenty-three countries.
The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the bosentan profile page.
US ANDA Litigation and Generic Entry Outlook for Tracleer
A generic version of TRACLEER was approved as bosentan by AMNEAL PHARMS CO on April 26th, 2019.
Summary for TRACLEER
| International Patents: | 28 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 39 |
| Patent Applications: | 3,465 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRACLEER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRACLEER |
| DailyMed Link: | TRACLEER at DailyMed |
Recent Clinical Trials for TRACLEER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | Phase 1 |
| Geropharm | Phase 1 |
Pharmacology for TRACLEER
| 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 TRACLEER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 TRACLEER
| 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 TRACLEER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 922323 | Start Trial |
| Norway | 2002012 | Start Trial |
| Canada | 2071193 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRACLEER
| 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 | 300097 | Netherlands | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
