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.
Summary for UPTRAVI
International Patents: | 148 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 4 |
Patent Applications: | 253 |
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 |
Recent Clinical Trials for UPTRAVI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Glasgow | Phase 4 |
University of Sheffield | Phase 4 |
University of Cambridge | Phase 4 |
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.
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 |
---|---|---|---|
Hungary | E036071 | ⤷ Try a Trial | |
Norway | 2315587 | ⤷ Try a Trial | |
Israel | 216928 | צורה גבישית של 2-{4-[n-(5,6-דיפנילפיראזינ-2-איל)-n- איזופרופילאמינו] בוטוקסי}-n-(מתילסולפוניל) אצטאמיד, הרכב פרמצבטי המכיל אותה והשימוש בו להכנת תרופה (Crystal form of 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino] butyloxy}-n-(methylsulfonyl) acetamide, pharmaceutical composition comprising it and its use in the manufacture of a medicament) | ⤷ Try a Trial |
Portugal | 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 |
---|---|---|---|---|
2447254 | PA2018008 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512 |
1400518 | 122016000077 | Germany | ⤷ Try a Trial | PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512 |
2447254 | C20180012 00263 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016 |
1400518 | 300836 | Netherlands | ⤷ Try a Trial | 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 |