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Last Updated: May 29, 2024

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 two Paragraph IV challenges.

This drug has one hundred and fifty-one patent family members in thirty-eight 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® Litigation and Generic Entry Outlook for Uptravi

A generic version of UPTRAVI was approved as selexipag by ALEMBIC on October 11th, 2023.

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Drug patent expirations by year for UPTRAVI
Drug Prices for UPTRAVI

See drug prices for UPTRAVI

Recent Clinical Trials for UPTRAVI

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

SponsorPhase
University of SheffieldPhase 4
University of CambridgePhase 4
University of Newcastle Upon-TynePhase 4

See all UPTRAVI clinical trials

Pharmacology for UPTRAVI
Paragraph IV (Patent) Challenges for UPTRAVI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UPTRAVI For Injection selexipag 1.8 mg/vial 214275 1 2022-07-29
UPTRAVI Tablets selexipag 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg 207947 4 2019-12-23

US Patents and Regulatory Information for UPTRAVI

UPTRAVI is protected by six US patents.

Patents protecting UPTRAVI

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

Heterocyclic compound derivatives and medicines
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic compositions containing macitentan
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG

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 207947-007 Dec 21, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actelion UPTRAVI selexipag TABLET;ORAL 207947-005 Dec 21, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actelion UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for UPTRAVI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen Cilag International NV Uptravi selexipag EMEA/H/C/003774
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies., , Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.,
Authorised no no no 2016-05-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for UPTRAVI

When does loss-of-exclusivity occur for UPTRAVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7242
Estimated Expiration: ⤷  Sign Up

Patent: 1658
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Australia

Patent: 10263569
Estimated Expiration: ⤷  Sign Up

Patent: 16366073
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Brazil

Patent: 1015936
Estimated Expiration: ⤷  Sign Up

Patent: 2018009534
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Patent: 2021005510
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Canada

Patent: 64475
Estimated Expiration: ⤷  Sign Up

Patent: 05169
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Chile

Patent: 11003264
Estimated Expiration: ⤷  Sign Up

Patent: 18001464
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China

Patent: 2459198
Estimated Expiration: ⤷  Sign Up

Patent: 4326991
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Patent: 8289890
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Colombia

Patent: 30432
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Patent: 18006834
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Croatia

Patent: 0180171
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Patent: 0200539
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Cyprus

Patent: 19788
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Patent: 22893
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Patent: 18011
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Denmark

Patent: 47254
Estimated Expiration: ⤷  Sign Up

Patent: 75871
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 18049108
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European Patent Office

Patent: 47254
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Patent: 75871
Estimated Expiration: ⤷  Sign Up

Patent: 84911
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Patent: 89855
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Patent: 31607
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Hong Kong

Patent: 44788
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Hungary

Patent: 36721
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Patent: 48467
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Patent: 800015
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Israel

Patent: 6928
Estimated Expiration: ⤷  Sign Up

Patent: 3287
Estimated Expiration: ⤷  Sign Up

Patent: 9461
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Patent: 0203
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Japan

Patent: 2010150865
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Patent: 2017098998
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Patent: 25574
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Lithuania

Patent: 447254
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Patent: 2018008
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Patent: 47254
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Patent: 75871
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Malaysia

Patent: 6531
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Mexico

Patent: 6318
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Patent: 11013471
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Patent: 18006343
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Morocco

Patent: 637
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New Zealand

Patent: 7352
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Norway

Patent: 18015
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Patent: 47254
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Peru

Patent: 181072
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Philippines

Patent: 015502824
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Patent: 015502825
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Patent: 018501161
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Poland

Patent: 47254
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Patent: 75871
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Portugal

Patent: 47254
Estimated Expiration: ⤷  Sign Up

Patent: 75871
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Russian Federation

Patent: 56206
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Patent: 35547
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Patent: 12102678
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Patent: 18123304
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Singapore

Patent: 6915
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Patent: 201403313W
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Patent: 201804320Q
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Slovenia

Patent: 47254
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Patent: 75871
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South Africa

Patent: 1109099
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Patent: 1804387
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South Korea

Patent: 120109457
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Patent: 170024165
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Patent: 180081141
Patent: 2-{4-[N--N-이소프로필아미노]부틸옥시}-N-아세트아미드를 함유하는 의약 조성물
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 60007
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Patent: 97124
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Taiwan

Patent: 31565
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Patent: 50143
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Patent: 1111352
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Patent: 1720444
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Ukraine

Patent: 8849
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Patent: 4002
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering UPTRAVI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2017098998 ⤷  Sign Up
Taiwan I446911 ⤷  Sign Up
Mexico PA03009800 DERIVADOS Y MEDICINAS DE COMPUSTOS HETEROCiCLICOS. (COMPOSITING OF IMAGES IN A CINEMATOGRAPHIC PUPPETRY PRODUCTION.) ⤷  Sign Up
Taiwan 201010985 Therapeutic compositions containing macitentan ⤷  Sign Up
Japan 2015187148 マシテンタン含有治療用組成物 (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UPTRAVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 2016/047 Ireland ⤷  Sign Up PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518 16C0042 France ⤷  Sign Up PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254 325 10-2018 Slovakia ⤷  Sign Up PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518 44/2016 Austria ⤷  Sign Up PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519
1400518 300836 Netherlands ⤷  Sign Up PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION 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.