Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 9, 2019

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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 patent family members in thirty-three 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
ActelionPhase 2/Phase 3
ActelionPhase 4
ActelionPhase 2

See all selexipag clinical trials

Recent Litigation for selexipag

Identify potential future generic entrants

District Court Litigation
Case NameDate
NIPPON SHINYAKU CO., LTD. v. KAPPOS2010-07-06

See all selexipag litigation

Pharmacology for selexipag
Synonyms for selexipag
144383-EP2289518A1
144383-EP2292231A1
2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-N-(methylsulfonyl)acetamide
2-(4-((5,6-Diphenylpyrazin-2-yl)(propan-2-yl)amino)butoxy}-n-(methanesulfonyl)acetamide
2-(4-((5,6-Diphenylpyrazinyl)(1-methylethyl)amino)butoxy)-N-(methylsulfonyl)-acetamide
2-[4-[(5,6-Diphenyl-2-pyrazinyl)(1-methylethyl)amino]butoxy]-N-(methylsulfonyl)acetamide
2-[4-[[5,6-di(phenyl)pyrazin-2-yl]-propan-2-ylamino]butoxy]-N-methylsulfonylacetamide
2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-(methanesulfonyl)acetamide
2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-methanesulfonylacetamide
2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide
3938AH
475086-01-2
5EXC0E384L
AC-30209
ACT 293987
ACT-293987
AK298890
AKOS024457572
B7378
BCP09146
CHEBI:90844
CHEMBL238804
CS-3774
CTK8F0123
D09994
DB11362
GTPL7552
HY-14870
KB-79567
KS-00000L89
MolPort-009-019-323
NCGC00370833-01
NS 304
NS 304; ACT 293987; Uptravi
NS-304
NS-304(Selexipag)
QXWZQTURMXZVHJ-UHFFFAOYSA-N
RT-014761
SB17055
SCHEMBL674122
Selexipag (JAN/USAN/INN)
Selexipag [USAN:INN]
Selexipag(NS-304)
UNII-5EXC0E384L
Uptravi
Uptravi (TN)
ZINC3990451

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 207947-008 Dec 21, 2015 RX Yes Yes   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 207947-006 Dec 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 RX Yes No   Start Trial   Start Trial Y Y   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 207947-002 Dec 21, 2015 RX Yes No   Start Trial   Start Trial Y Y   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 2016/047 Ireland   Start Trial PRODUCT NAME: SELEXIPAG OR SALT THEREOF; 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
1400518 1690044-1 Sweden   Start Trial PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. 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 16C0042 France   Start Trial PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254 PA2018008 Lithuania   Start Trial PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKesson
Medtronic
Baxter
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.