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Bosentan - Generic Drug Details
What are the generic drug sources for bosentan and what is the scope of bosentan freedom to operate?
Bosentan
is the generic ingredient in one branded drug marketed by Actelion Pharms and Actelion Pharms Ltd, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are nineteen drug master file entries for bosentan. One supplier is listed for this compound.
Summary for bosentan
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 73 |
| Clinical Trials: | 116 |
| Patent Applications: | 4,936 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for bosentan |
| DailyMed Link: | bosentan at DailyMed |
Pharmacology for bosentan
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists Cytochrome P450 3A Inducers Cytochrome P450 2C9 Inducers |
Synonyms for bosentan
| 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]-?BENZENESULFONAMIDE |
| 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-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 |
| BCP9000445 |
| BDBM50061101 |
| Benzenesulfonamide, 4-(1,1-dimethylethyl)-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)(2,2'-bipyrimidin)-4-yl)- |
| Bosentan (INN) |
| Bosentan [USAN:INN:BAN] |
| bosentan anhydrous |
| bosentanum |
| C27H29N5O6S |
| CAS-147536-97-8 |
| CCG-221182 |
| CHEBI:51450 |
| CHEMBL957 |
| CS-0381 |
| CTK4D4929 |
| D07538 |
| D0U4CE |
| DB00559 |
| DR003249 |
| DSSTox_CID_26627 |
| DSSTox_GSID_46627 |
| DSSTox_RID_81776 |
| DTXSID7046627 |
| EN002863 |
| FT-0658809 |
| GJPICJJJRGTNOD-UHFFFAOYSA-N |
| GTPL3494 |
| HE226108 |
| HE312639 |
| HE312640 |
| HMS2090N14 |
| HMS3652F15 |
| 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 |
| p-tert-Butyl-N-[6-(2-hydroxyethoxy) |
| 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 |
| SC-19679 |
| SCHEMBL4218 |
| SR-05000001532 |
| SR-05000001532-4 |
| stayveer |
| TL8001039 |
| Tox21_112444 |
| Tox21_112444_1 |
| Tracleer |
| Tracleer (TN) |
| UNII-XUL93R30K2 |
| VA10428 |
| W-5165 |
| XUL93R30K2 |
| Z1541632805 |
| ZINC1538857 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion Pharms Ltd | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Actelion Pharms Ltd | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Actelion Pharms | TRACLEER | bosentan | TABLET, FOR SUSPENSION;ORAL | 209279-001 | Sep 5, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Actelion Pharms Ltd | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for bosentan
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2404774 | ➤ Try a Free Trial |
| Denmark | 1883397 | ➤ Try a Free Trial |
| Canada | 2607098 | ➤ Try a Free Trial |
| South Korea | 20080014002 | ➤ Try a Free Trial |
| Germany | 602006011150 | ➤ Try a Free Trial |
| Portugal | 1883397 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for bosentan
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00097 | Netherlands | ➤ Try a Free 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 |
| 90017-3 | Sweden | ➤ Try a Free Trial | PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228 |
| C/GB02/030 | United Kingdom | ➤ Try a Free 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 |
| C0042 | France | ➤ Try a Free Trial | PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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