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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 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.
DrugPatentWatch® 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: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 40 |
| Patent Applications: | 4,694 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRACLEER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRACLEER |
| What excipients (inactive ingredients) are in TRACLEER? | TRACLEER excipients list |
| DailyMed Link: | TRACLEER at DailyMed |
Recent Clinical Trials for TRACLEER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Mississippi Medical Center | Early Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | 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 | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | AB | RX | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Actelion | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Actelion | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | AB | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| >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 | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | Get Started for $10 | Get Started for $10 |
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRACLEER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Romania | 111268 | Get Started for $10 |
| South Africa | 200710903 | Get Started for $10 |
| Germany | 10299047 | Get Started for $10 |
| Russian Federation | 2007146395 | Get Started for $10 |
| Denmark | 0526708 | Get Started for $10 |
| >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 | Get Started for $10 | PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228 |
| 0526708 | CA 2002 00026 | Denmark | Get Started for $10 | |
| 0526708 | 300097 | Netherlands | Get Started for $10 | |
| 0526708 | 02C0042 | France | Get Started for $10 | PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228 |
| 0526708 | C300097 | Netherlands | Get Started for $10 | PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
