BOSENTAN Drug Patent Profile
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When do Bosentan patents expire, and what generic alternatives are available?
Bosentan is a drug marketed by Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Natco Pharma Ltd, Par Pharm Inc, Sun Pharm, Watson Labs Inc, and Zydus Pharms. and is included in eleven NDAs.
The generic ingredient in BOSENTAN is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bosentan
A generic version of BOSENTAN was approved as bosentan by SUN PHARM on April 26th, 2019.
Summary for BOSENTAN
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 131 |
| Patent Applications: | 4,458 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | BOSENTAN | bosentan | TABLET;ORAL | 211461-001 | Jan 23, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm | BOSENTAN | bosentan | TABLET;ORAL | 209324-002 | Apr 26, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Molecular | BOSENTAN | bosentan | TABLET;ORAL | 210342-001 | Jan 3, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alvogen Pine Brook | BOSENTAN | bosentan | TABLET;ORAL | 206002-002 | Apr 26, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
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 |
