TRACLEER Drug Patent Profile
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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. Nine 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 HIKMA on April 26th, 2019.
Summary for TRACLEER
| International Patents: | 28 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 43 |
| Patent Applications: | 4,300 |
| 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 |
|---|---|
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
| University of Mississippi Medical Center | Early Phase 1 |
Pharmacology for TRACLEER
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers Endothelin Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for TRACLEER
US Patents and Regulatory Information for TRACLEER
TRACLEER is protected by two US patents and two FDA Regulatory Exclusivities.
Patents protecting TRACLEER
Dispersible bosentan tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dispersible bosentan tablet
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting TRACLEER
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY
Exclusivity Expiration: ⤷ Try a Trial
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Actelion | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TRACLEER
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International N.V. | Tracleer | bosentan | EMEA/H/C/000401 Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in:, , , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology., , , Some improvements have also been shown in patients with PAH WHO functional class II., , Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease., |
Authorised | no | no | no | 2002-05-14 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TRACLEER
When does loss-of-exclusivity occur for TRACLEER?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06248593
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 1914
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0610187
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 07098
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1175484
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 10610
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 83397
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 83397
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2006011150
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 20212
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 7383
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 19399
Estimated Expiration: ⤷ Try a Trial
Patent: 08540512
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07014454
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4167
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 9781
Estimated Expiration: ⤷ Try a Trial
Patent: 076325
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 83397
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 83397
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 04774
Estimated Expiration: ⤷ Try a Trial
Patent: 07146395
Estimated Expiration: ⤷ Try a Trial
Patent: 10129460
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 83397
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0710903
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 080014002
Estimated Expiration: ⤷ Try a Trial
Patent: 100093105
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 36943
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TRACLEER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0526708 | Sulfonamide, sa préparation et son usage comme médicament et intermédiaire (Sulfonamide, preparation and use thereof as medicine and intermediate) | ⤷ Try a Trial |
| Norway | 339781 | ⤷ Try a Trial | |
| Algeria | 1587 | Nouveaux sulfonamides. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRACLEER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0526708 | 300097 | Netherlands | ⤷ Try a Trial | |
| 0526708 | SPC/GB02/030 | United Kingdom | ⤷ Try a 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 | CA 2002 00026 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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