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TRACLEER Drug Profile
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-seven patent family members in twenty-two countries.
The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bosentan profile page.
Summary for TRACLEER
| International Patents: | 27 |
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 38 |
| Patent Applications: | 3,314 |
| 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 |
|---|---|
| Geropharm | Phase 1 |
| Xuzhou Medical University | Phase 4 |
| Ochsner Health System | Phase 4 |
Recent Litigation for TRACLEER
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ACTELION PHARMACEUTICALS LTD. v. NATCO PHARMA LIMITED | 2019-05-28 |
Pharmacology for TRACLEER
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists Cytochrome P450 3A Inducers Cytochrome P450 2C9 Inducers |
Synonyms for TRACLEER
| 144096-EP2287165A2 |
| 144096-EP2287166A2 |
| 144096-EP2292620A2 |
| 147536-97-8 |
| 174227-18-0 |
| 212B550 |
| 4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl) benzenesulfornamide |
| 4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl)benzenesulfornamide |
| 4-(1,1-Dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-(2,2''-bipyrimidin)-4-yl) benzenesulfornamide |
| 4-(1,1-dimethylethyl)-n-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide |
| 4-(tert-butyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidin]-4-yl)benzenesulfonamide |
| 4-(tert-Butyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide |
| 4-t-butyl-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide |
| 4-tert butyl-N-[4-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)pyrimidin-6-yl]benzenesulphonamide |
| 4-tert-butyl-n-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide |
| 4-tert-Butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-[2,2'-bipyrimidine]-4-yl]benzene-1-sulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzene-1-sulfonamide |
| 4-tert-Butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)pyrimidin-4-yl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-ylpyrimidin-4-yl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2''-bipyrimidin-4-yl]benzenesulfonamide |
| 4-tert-butyl-N-[6-(2-hydroxyethyloxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]benzenesulfonamide |
| A808658 |
| AB0018010 |
| AB01275536-01 |
| ABP001094 |
| AC-148 |
| AC1L2XN2 |
| ACN-048487 |
| Actelion |
| AKOS015852063 |
| AM84442 |
| AN-16081 |
| B5118 |
| BCP05202 |
| BCP9000445 |
| BDBM50061101 |
| Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)(2,2'-bipyrimidin)-4-yl)- |
| Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]- |
| Bosentan |
| Bosentan (INN) |
| Bosentan [USAN:INN:BAN] |
| bosentanum |
| C27H29N5O6S |
| CAS-147536-97-8 |
| CCG-221182 |
| CHEBI:51450 |
| CHEMBL957 |
| CS-0381 |
| CTK4D4929 |
| D07538 |
| DB00559 |
| DSSTox_CID_26627 |
| DSSTox_GSID_46627 |
| DSSTox_RID_81776 |
| DTXSID7046627 |
| EN002863 |
| FT-0658809 |
| GJPICJJJRGTNOD-UHFFFAOYSA-N |
| GTPL3494 |
| HMS2090N14 |
| HMS3652F15 |
| HMS3715N05 |
| HY-A0013 |
| I06-1873 |
| J-008366 |
| K86 |
| KS-5062 |
| L001086 |
| LS-31532 |
| MCULE-3074160312 |
| MolPort-003-845-300 |
| N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-pyrimidin-2-yl-pyrimidin-4-yl]-4-tert-butyl-benzenesulfonamide |
| NCGC00167440-01 |
| NCGC00167440-02 |
| p-tert-Butyl-N-(6-(2-hydroxyethoxy)-5-(o-methoxyphenoxy)-2-(2-pyrimidinyl)-4-pyrimidinyl)benzenesulfonamide |
| PDSP1_001731 |
| PDSP2_001714 |
| PubChem19119 |
| Ro 47-0203 |
| Ro 47-0203/039 |
| Ro-47-0203 |
| Ro-47-0203-029 |
| Ro-47-0203/029 |
| Ro-47-0203/039 |
| Ro-470203029 |
| s4220 |
| SB17356 |
| SC-19679 |
| SCHEMBL4218 |
| SR-05000001532 |
| SR-05000001532-1 |
| SR-05000001532-2 |
| SR-05000001532-4 |
| SW199648-3 |
| TL8001039 |
| Tox21_112444 |
| Tox21_112444_1 |
| UNII-XUL93R30K2 |
| VA10428 |
| W-5165 |
| XUL93R30K2 |
| Z1541632805 |
| ZINC1538857 |
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 | |||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | 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 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 |
Paragraph IV (Patent) Challenges for TRACLEER
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | for Oral Suspension | 32 mg | ➤ Subscribe | Start Trial |
International Patents for TRACLEER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1120212 | Start Trial |
| European Patent Office | 1883397 | Start Trial |
| China | 101175484 | Start Trial |
| Germany | 602006011150 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRACLEER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 | C300097 | Netherlands | Start Trial | 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 |
