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Last Updated: July 4, 2020

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Selexipag - Generic Drug Details

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

Selexipag is the generic ingredient in one branded drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selexipag has one hundred and thirteen patent family members in thirty-five countries.

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

Recent Clinical Trials for selexipag

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

SponsorPhase
Janssen Research & Development, LLCPhase 3
ActelionPhase 2/Phase 3
ActelionPhase 4

See all selexipag clinical trials

Pharmacology for selexipag
Paragraph IV (Patent) Challenges for SELEXIPAG
Tradename Dosage Ingredient NDA Submissiondate
UPTRAVI TABLET;ORAL selexipag 207947 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 Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-001 Dec 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-002 Dec 21, 2015 RX Yes Yes   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

Supplementary Protection Certificates for selexipag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 93266 Luxembourg   Start Trial PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
2447254 PA2018008 Lithuania   Start Trial PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518 CR 2016 00048 Denmark   Start Trial PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Dow
Baxter
Johnson and Johnson
Boehringer Ingelheim

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