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Last Updated: March 3, 2024

Selexipag - Generic Drug Details

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What are the generic sources for selexipag and what is the scope of freedom to operate?

Selexipag is the generic ingredient in two branded drugs marketed by Actelion, Alembic, and Zydus, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selexipag has one hundred and forty-eight patent family members in thirty-eight countries.

There are two drug master file entries for selexipag. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for selexipag
Recent Clinical Trials for selexipag

Identify potential brand extensions & 505(b)(2) entrants

University of SheffieldPhase 4
University of CambridgePhase 4
University of Newcastle Upon-TynePhase 4

See all selexipag clinical trials

Generic filers with tentative approvals for SELEXIPAG
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1600MCGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1400MCGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1200MCGTABLET;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 selexipag
Paragraph IV (Patent) Challenges for SELEXIPAG
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UPTRAVI For Injection selexipag 1.8 mg/vial 214275 1 2022-07-29
UPTRAVI Tablets selexipag 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg 207947 4 2019-12-23

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 214414-002 Oct 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-006 Dec 21, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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 selexipag

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen Cilag International NV Uptravi selexipag EMEA/H/C/003774
Uptravi 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

Supplementary Protection Certificates for selexipag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 1690044-1 Sweden ⤷  Try a Trial PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
2447254 C20180012 00263 Estonia ⤷  Try a Trial PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
1400518 93266 Luxembourg ⤷  Try a Trial PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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