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Last Updated: January 19, 2021

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

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 207947-006 Dec 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-005 Dec 21, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-003 Dec 21, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-001 Dec 21, 2015 RX Yes 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

Supplementary Protection Certificates for selexipag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2447254 2018015 Norway   Start Trial PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1400518 16C0042 France   Start Trial PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518 93266 Luxembourg   Start Trial PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518 1690044-1 Sweden   Start Trial PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518 132016000106856 Italy   Start Trial PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
1400518 122016000077 Germany   Start Trial PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Boehringer Ingelheim
McKesson
Harvard Business School
Medtronic

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