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Last Updated: March 19, 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 forty-eight 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
Sheffield Teaching Hospitals NHS Foundation TrustPhase 4
University of GlasgowPhase 4
University of SheffieldPhase 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG

Heterocyclic compound derivatives and medicines
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions containing macitentan
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-005 Dec 21, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actelion UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 1658
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 10263569
Estimated Expiration: ⤷  Try a Trial

Patent: 16366073
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 1015936
Estimated Expiration: ⤷  Try a Trial

Patent: 2018009534
Estimated Expiration: ⤷  Try a Trial

Patent: 2021005510
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 64475
Estimated Expiration: ⤷  Try a Trial

Patent: 05169
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11003264
Estimated Expiration: ⤷  Try a Trial

Patent: 18001464
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2459198
Estimated Expiration: ⤷  Try a Trial

Patent: 4326991
Estimated Expiration: ⤷  Try a Trial

Patent: 8289890
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 30432
Estimated Expiration: ⤷  Try a Trial

Patent: 18006834
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180171
Estimated Expiration: ⤷  Try a Trial

Patent: 0200539
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19788
Estimated Expiration: ⤷  Try a Trial

Patent: 22893
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 18049108
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

Patent: 84911
Estimated Expiration: ⤷  Try a Trial

Patent: 89855
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 44788
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 36721
Estimated Expiration: ⤷  Try a Trial

Patent: 48467
Estimated Expiration: ⤷  Try a Trial

Patent: 800015
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6928
Estimated Expiration: ⤷  Try a Trial

Patent: 3287
Estimated Expiration: ⤷  Try a Trial

Patent: 9461
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2010150865
Estimated Expiration: ⤷  Try a Trial

Patent: 2017098998
Estimated Expiration: ⤷  Try a Trial

Patent: 25574
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 447254
Estimated Expiration: ⤷  Try a Trial

Patent: 2018008
Estimated Expiration: ⤷  Try a Trial

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6531
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6318
Estimated Expiration: ⤷  Try a Trial

Patent: 11013471
Estimated Expiration: ⤷  Try a Trial

Patent: 18006343
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 637
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7352
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 18015
Estimated Expiration: ⤷  Try a Trial

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 181072
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015502824
Estimated Expiration: ⤷  Try a Trial

Patent: 015502825
Estimated Expiration: ⤷  Try a Trial

Patent: 018501161
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 56206
Estimated Expiration: ⤷  Try a Trial

Patent: 35547
Estimated Expiration: ⤷  Try a Trial

Patent: 12102678
Estimated Expiration: ⤷  Try a Trial

Patent: 18123304
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 6915
Estimated Expiration: ⤷  Try a Trial

Patent: 201403313W
Estimated Expiration: ⤷  Try a Trial

Patent: 201804320Q
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 47254
Estimated Expiration: ⤷  Try a Trial

Patent: 75871
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1109099
Estimated Expiration: ⤷  Try a Trial

Patent: 1804387
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 120109457
Estimated Expiration: ⤷  Try a Trial

Patent: 170024165
Estimated Expiration: ⤷  Try a Trial

Patent: 180081141
Patent: 2-{4-[N--N-이소프로필아미노]부틸옥시}-N-아세트아미드를 함유하는 의약 조성물
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 60007
Estimated Expiration: ⤷  Try a Trial

Patent: 97124
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 31565
Estimated Expiration: ⤷  Try a Trial

Patent: 50143
Estimated Expiration: ⤷  Try a Trial

Patent: 1111352
Estimated Expiration: ⤷  Try a Trial

Patent: 1720444
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8849
Estimated Expiration: ⤷  Try a Trial

Patent: 4002
Estimated Expiration: ⤷  Try a Trial

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
South Korea 20170024165 결정 (CRYSTALS) ⤷  Try a Trial
Australia 2009280843 Therapeutic compositions containing macitentan ⤷  Try a Trial
Japan 5956025 ⤷  Try a Trial
Denmark 3300729 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UPTRAVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 CR 2016 00048 Denmark ⤷  Try a Trial PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518 532 Finland ⤷  Try a Trial
1400518 2016/047 Ireland ⤷  Try a Trial PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
2447254 PA2018008 Lithuania ⤷  Try a Trial PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
>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.