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Last Updated: January 17, 2022

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UPTRAVI Drug Patent Profile


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Which patents cover Uptravi, and what generic alternatives are available?

Uptravi is a drug marketed by Actelion and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-two patent family members in thirty-seven countries.

The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.

DrugPatentWatch® 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.

There is one tentative approval for the generic drug (selexipag), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for UPTRAVI
Drug Prices for UPTRAVI

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for UPTRAVI
Generic Entry Dates for UPTRAVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for UPTRAVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*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 4
ActelionPhase 3

See all UPTRAVI clinical trials

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

UPTRAVI is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UPTRAVI is ⤷  Try it Free.

This potential generic entry date is based on patent ⤷  Try it Free.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting UPTRAVI

Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG

Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG

Heterocyclic compound derivatives and medicines
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG

Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Therapeutic compositions containing macitentan
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN

Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG

FDA Regulatory Exclusivity protecting UPTRAVI

FOR USE OF UPTRAVI (SELEXIPAG) TABLETS, 200, 400, 600, 800, 1000, 1200, 1400, AND 1600 MCG FOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I) TO REDUCE THE RISKS OF DISEASE PROGRESSION AND HOSPITALIZATION FOR PAH
Exclusivity Expiration: ⤷  Try it Free

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion UPTRAVI selexipag TABLET;ORAL 207947-006 Dec 21, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actelion UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actelion UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actelion UPTRAVI selexipag TABLET;ORAL 207947-006 Dec 21, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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
2447254 325 10-2018 Slovakia ⤷  Try it Free PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518 300836 Netherlands ⤷  Try it Free PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518 132016000106856 Italy ⤷  Try it Free PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
2447254 2018015 Norway ⤷  Try it Free PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1400518 532 Finland ⤷  Try it Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKesson
McKinsey
Baxter
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.