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Selexipag - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for selexipag?

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.

This ingredient has sixty-four patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for Generic Name: selexipag

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Bulk Api Vendors: see list27
Clinical Trials: see list6
Patent Applications: see list24
Drug Prices:see low prices
DailyMed Link:selexipag at DailyMed

Pharmacology for Ingredient: selexipag

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-007Dec 21, 2015RXYesNo► Subscribe► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-007Dec 21, 2015RXYesNo► Subscribe► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-002Dec 21, 2015RXYesNo9,284,280► Subscribe ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-005Dec 21, 2015RXYesNo7,205,302► SubscribeYY ► Subscribe
Actelion Pharms Ltd
UPTRAVI
selexipag
TABLET;ORAL207947-006Dec 21, 2015RXYesNo► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: selexipag

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,809,334Therapeutic compositions containing macitentan► Subscribe
9,340,516Form-II crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl) acetamide, method for producing the same, and use thereof► Subscribe
9,440,931Form-III crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and use thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: selexipag

Country Document Number Estimated Expiration
New Zealand597352► Subscribe
Canada2731370► Subscribe
Mexico2011001625► Subscribe
Russian Federation2012102678► Subscribe
Taiwan201010985► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SELEXIPAG

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00048Denmark► SubscribePRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
266Luxembourg► SubscribePRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
0836Netherlands► SubscribePRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
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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 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.

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