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Last Updated: January 23, 2021

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UPTRAVI Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Uptravi

Uptravi was eligible for patent challenges on December 21, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 1, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for UPTRAVI
Drug Prices for UPTRAVI

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Generic Entry Opportunity Date for UPTRAVI
Generic Entry Date for UPTRAVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for UPTRAVI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ActelionPhase 3
ActelionPhase 4

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Pharmacology for UPTRAVI
Paragraph IV (Patent) Challenges for UPTRAVI
Tradename Dosage Ingredient NDA Submissiondate
UPTRAVI TABLET;ORAL selexipag 207947 2019-12-23

US Patents and Regulatory Information for UPTRAVI

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 207947-007 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 Y Y   Start Trial
Actelion Pharms Ltd UPTRAVI selexipag TABLET;ORAL 207947-008 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   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 UPTRAVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 44/2016 Austria   Start Trial PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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.