SELEXIPAG Drug Patent Profile
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Which patents cover Selexipag, and what generic alternatives are available?
Selexipag is a drug marketed by Alembic, Rk Pharma, and Zydus Lifesciences. and is included in three NDAs.
The generic ingredient in SELEXIPAG is selexipag. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the selexipag profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Selexipag
A generic version of SELEXIPAG was approved as selexipag by ALEMBIC on October 11th, 2023.
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Questions you can ask:
- What is the 5 year forecast for SELEXIPAG?
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- What is Average Wholesale Price for SELEXIPAG?
Summary for SELEXIPAG
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 24 |
| Patent Applications: | 510 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SELEXIPAG |
| DailyMed Link: | SELEXIPAG at DailyMed |
Recent Clinical Trials for SELEXIPAG
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Humanis Saglk Anonim Sirketi | PHASE1 |
| University of Sheffield | Phase 4 |
| University of Cambridge | Phase 4 |
Pharmacology for SELEXIPAG
| Drug Class | Prostacyclin Receptor Agonist |
| Mechanism of Action | Prostacyclin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SELEXIPAG
US Patents and Regulatory Information for SELEXIPAG
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | SELEXIPAG | selexipag | TABLET;ORAL | 214414-001 | Oct 11, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Lifesciences | SELEXIPAG | selexipag | TABLET;ORAL | 214302-004 | Dec 21, 2022 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rk Pharma | SELEXIPAG | selexipag | TABLET;ORAL | 214055-001 | Apr 16, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | SELEXIPAG | selexipag | TABLET;ORAL | 214414-004 | Oct 11, 2023 | AB | RX | No | No | ⤷ 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 |
EU/EMA Drug Approvals for SELEXIPAG
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Cilag International NV | Uptravi | selexipag | EMEA/H/C/003774Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies., , 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 | no | 2016-05-12 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
