BOSENTAN - Generic Drug Details
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What are the generic sources for bosentan and what is the scope of freedom to operate?
Bosentan
is the generic ingredient in two branded drugs marketed by Actelion, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Bosentan has twenty-eight patent family members in twenty-three countries.
There are nineteen drug master file entries for bosentan. Six suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for BOSENTAN
International Patents: | 28 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 13 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 131 |
Patent Applications: | 6,500 |
Drug Prices: | Drug price trends for BOSENTAN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BOSENTAN |
What excipients (inactive ingredients) are in BOSENTAN? | BOSENTAN excipients list |
DailyMed Link: | BOSENTAN at DailyMed |
Recent Clinical Trials for BOSENTAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CTI BioPharma | Phase 1 |
PPD | Phase 1 |
Jean-Pierre Routy | N/A |
Generic filers with tentative approvals for BOSENTAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 125MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 62.5MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 32MG | TABLET, FOR SUSPENSION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for BOSENTAN
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 BOSENTAN
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms | BOSENTAN | bosentan | TABLET;ORAL | 207760-001 | Apr 26, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | BOSENTAN | bosentan | TABLET;ORAL | 205699-002 | Apr 26, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | BOSENTAN | bosentan | TABLET;ORAL | 208695-001 | Apr 26, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alvogen Pine Brook | BOSENTAN | bosentan | TABLET;ORAL | 206002-002 | Apr 26, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mylan | BOSENTAN | bosentan | TABLET;ORAL | 205173-002 | Jan 15, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | TRACLEER | bosentan | TABLET;ORAL | 021290-001 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Actelion | TRACLEER | bosentan | TABLET;ORAL | 021290-002 | Nov 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BOSENTAN
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 BOSENTAN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20076325 | ⤷ Sign Up | |
Denmark | 1883397 | ⤷ Sign Up | |
European Patent Office | 1883397 | COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET) | ⤷ Sign Up |
Canada | 2607098 | COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET) | ⤷ Sign Up |
Hong Kong | 1120212 | DISPERSIBLE BOSERTAN TABLET | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BOSENTAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0526708 | SPC/GB02/030 | United Kingdom | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228 |
0526708 | 0290017-3 | Sweden | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
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