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Selexipag - Generic Drug Details
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.
Summary for selexipag
| International Patents: | 113 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 19 |
| Patent Applications: | 64 |
| 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 |
|---|---|
| Janssen Research & Development, LLC | Phase 3 |
| Actelion | Phase 2/Phase 3 |
| Actelion | Phase 4 |
Pharmacology for selexipag
| Drug Class | Prostacyclin Receptor Agonist |
| Mechanism of Action | Prostacyclin Receptor Agonists |
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 |
International Patents for selexipag
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2283835 | Start Trial |
| Norway | 2315587 | Start Trial |
| Brazil | PI0209249 | Start Trial |
| >Country | >Patent Number | >Estimated 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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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 verification 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.
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