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Last Updated: January 28, 2023

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-nine 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® 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

See drug prices for UPTRAVI

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 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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UPTRAVI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG

Heterocyclic compound derivatives and medicines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions containing macitentan
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-004 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-007 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-008 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actelion UPTRAVI selexipag TABLET;ORAL 207947-006 Dec 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Patent: 1658
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10263569
Estimated Expiration: See Plans and Pricing

Patent: 16366073
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1015936
Estimated Expiration: See Plans and Pricing

Patent: 2018009534
Estimated Expiration: See Plans and Pricing

Patent: 2021005510
Estimated Expiration: See Plans and Pricing

Canada

Patent: 64475
Estimated Expiration: See Plans and Pricing

Patent: 05169
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11003264
Estimated Expiration: See Plans and Pricing

Patent: 18001464
Estimated Expiration: See Plans and Pricing

China

Patent: 2459198
Estimated Expiration: See Plans and Pricing

Patent: 4326991
Estimated Expiration: See Plans and Pricing

Patent: 8289890
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30432
Estimated Expiration: See Plans and Pricing

Patent: 18006834
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180171
Estimated Expiration: See Plans and Pricing

Patent: 0200539
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19788
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 18049108
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

Patent: 84911
Estimated Expiration: See Plans and Pricing

Patent: 89855
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 44788
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 36721
Estimated Expiration: See Plans and Pricing

Patent: 48467
Estimated Expiration: See Plans and Pricing

Patent: 800015
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6928
Estimated Expiration: See Plans and Pricing

Patent: 3287
Estimated Expiration: See Plans and Pricing

Patent: 3293
Estimated Expiration: See Plans and Pricing

Patent: 9461
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2010150865
Estimated Expiration: See Plans and Pricing

Patent: 2017098998
Estimated Expiration: See Plans and Pricing

Patent: 25574
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 447254
Estimated Expiration: See Plans and Pricing

Patent: 2018008
Estimated Expiration: See Plans and Pricing

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6531
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6318
Estimated Expiration: See Plans and Pricing

Patent: 11013471
Estimated Expiration: See Plans and Pricing

Patent: 18006343
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 637
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7352
Estimated Expiration: See Plans and Pricing

Norway

Patent: 18015
Estimated Expiration: See Plans and Pricing

Patent: 47254
Estimated Expiration: See Plans and Pricing

Peru

Patent: 181072
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015502824
Estimated Expiration: See Plans and Pricing

Patent: 015502825
Estimated Expiration: See Plans and Pricing

Patent: 018501161
Estimated Expiration: See Plans and Pricing

Poland

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 56206
Estimated Expiration: See Plans and Pricing

Patent: 35547
Estimated Expiration: See Plans and Pricing

Patent: 12102678
Estimated Expiration: See Plans and Pricing

Patent: 18123304
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 6915
Estimated Expiration: See Plans and Pricing

Patent: 201403313W
Estimated Expiration: See Plans and Pricing

Patent: 201804320Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 47254
Estimated Expiration: See Plans and Pricing

Patent: 75871
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1109099
Estimated Expiration: See Plans and Pricing

Patent: 1804387
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 120109457
Estimated Expiration: See Plans and Pricing

Patent: 170024165
Estimated Expiration: See Plans and Pricing

Patent: 180081141
Estimated Expiration: See Plans and Pricing

Spain

Patent: 60007
Estimated Expiration: See Plans and Pricing

Patent: 97124
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 31565
Estimated Expiration: See Plans and Pricing

Patent: 50143
Estimated Expiration: See Plans and Pricing

Patent: 1111352
Estimated Expiration: See Plans and Pricing

Patent: 1720444
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8849
Estimated Expiration: See Plans and Pricing

Patent: 4002
Estimated Expiration: See Plans and Pricing

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
Japan 2011530581 See Plans and Pricing
Japan 5956026 See Plans and Pricing
Mexico PA03009800 DERIVADOS Y MEDICINAS DE COMPUSTOS HETEROCiCLICOS. (COMPOSITING OF IMAGES IN A CINEMATOGRAPHIC PUPPETRY PRODUCTION.) See Plans and Pricing
Australia 2016366073 Pharmaceutical composition containing 2-{4-[N-(5,6- diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N- (methylsulfonyl)acetamide See Plans and Pricing
Philippines 12015502825 CRYSTALS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UPTRAVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1400518 122016000077 Germany See Plans and Pricing PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
1400518 CA 2016 00048 Denmark See Plans and Pricing PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
2447254 2018015 Norway See Plans and Pricing PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1400518 1690044-1 Sweden See Plans and Pricing PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518 93266 Luxembourg See Plans and Pricing PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey
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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.