MACITENTAN Drug Patent Profile
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Which patents cover Macitentan, and when can generic versions of Macitentan launch?
Macitentan is a drug marketed by Apotex, Aurobindo Pharma Ltd, and Zydus. and is included in three NDAs.
The generic ingredient in MACITENTAN is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Macitentan
A generic version of MACITENTAN was approved as macitentan by APOTEX on January 9th, 2024.
Summary for MACITENTAN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 57 |
| Patent Applications: | 543 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MACITENTAN |
| DailyMed Link: | MACITENTAN at DailyMed |
Recent Clinical Trials for MACITENTAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen, LP | Phase 4 |
| American Heart Association | Phase 4 |
| Janssen Pharmaceutical K.K. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for MACITENTAN
Paragraph IV (Patent) Challenges for MACITENTAN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OPSUMIT | Tablets | macitentan | 10 mg | 204410 | 11 | 2017-10-18 |
US Patents and Regulatory Information for MACITENTAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | MACITENTAN | macitentan | TABLET;ORAL | 211195-001 | Jan 9, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma Ltd | MACITENTAN | macitentan | TABLET;ORAL | 211198-001 | Apr 18, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus | MACITENTAN | macitentan | TABLET;ORAL | 211224-001 | Apr 6, 2021 | 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 MACITENTAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International N.V. | Opsumit | macitentan | EMEA/H/C/002697 Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. |
Authorised | no | no | yes | 2013-12-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
