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Last Updated: November 30, 2022

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 one branded drug marketed by Actelion and is included in two 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

SponsorPhase
Janssen-Cilag Ltd.Phase 2
University of Sao Paulo General HospitalPhase 2
Janssen Research & Development, LLCPhase 3

See all selexipag clinical trials

Generic filers with tentative approvals for SELEXIPAG
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1600MCGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1400MCGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1200MCGTABLET;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
Actelion UPTRAVI selexipag TABLET;ORAL 207947-002 Dec 21, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-002 Dec 21, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-001 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-006 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for selexipag

Country Patent Number Title Estimated Expiration
Japan WO2017098998 2−{4−[N−(5,6−ジフェニルピラジン−2−イル)−N−イソプロピルアミノ]ブチルオキシ}−N−(メチルスルホニル)アセトアミドを含有する医薬組成物 See Plans and Pricing
Russian Federation 2556206 КРИСТАЛЛЫ (CRYSTALS) See Plans and Pricing
Denmark 2315587 See Plans and Pricing
South Korea 20110045006 See Plans and Pricing
Taiwan I446911 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017098998 See Plans and Pricing
China 104326991 CRYSTALs See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selexipag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 132016000106856 Italy See Plans and Pricing PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
2447254 PA2018008,C2447254 Lithuania See Plans and Pricing PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518 1690044-1 Sweden See Plans and Pricing PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518 93266 Luxembourg See Plans and Pricing PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518 122016000077 Germany See Plans and Pricing PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
1400518 CA 2016 00048 Denmark See Plans and Pricing PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
2447254 325 10-2018 Slovakia See Plans and Pricing PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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