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
Summary for UPTRAVI
International Patents: | 149 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Clinical Trials: | 3 |
Patent Applications: | 317 |
Drug Prices: | Drug price information for UPTRAVI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for UPTRAVI |
What excipients (inactive ingredients) are in UPTRAVI? | UPTRAVI excipients list |
DailyMed Link: | UPTRAVI at DailyMed |


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
Sponsor | Phase |
---|---|
Actelion | Phase 4 |
Actelion | Phase 3 |
Pharmacology for UPTRAVI
Drug Class | Prostacyclin Receptor Agonist |
Mechanism of Action | Prostacyclin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for UPTRAVI
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 |