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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.
Summary for selexipag
International Patents: | 100 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 50 |
Clinical Trials: | 17 |
Patent Applications: | 62 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for selexipag |
DailyMed Link: | selexipag at DailyMed |
Recent Clinical Trials for selexipag
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Actelion | Phase 2/Phase 3 |
Actelion | Phase 4 |
Actelion | Phase 2 |
Recent Litigation for selexipag
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
NIPPON SHINYAKU CO., LTD. v. KAPPOS | 2010-07-06 |
Pharmacology for selexipag
Drug Class | Prostacyclin Receptor Agonist |
Mechanism of Action | Prostacyclin Receptor Agonists |
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 |
International Patents for selexipag
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 5956026 | Start Trial |
Norway | 2447254 | Start Trial |
South Africa | 201101900 | Start Trial |
Mexico | 2011013471 | Start Trial |
Ukraine | 108849 | Start Trial |
Denmark | 2315587 | Start Trial |
>Country | >Patent Number | >Estimated 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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