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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Summary for UPTRAVI
| International Patents: | 151 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 4 |
| Patent Applications: | 216 |
| 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 Sheffield | Phase 4 |
| University of Cambridge | Phase 4 |
| University of Newcastle Upon-Tyne | Phase 4 |
Pharmacology for UPTRAVI
| Drug Class | Prostacyclin Receptor Agonist |
| Mechanism of Action | Prostacyclin Receptor Agonists |
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
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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
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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 | |||
| >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
Patent: FORMAS CRISTALINAS DEL 2-{4-[N-(5,6-DIFENILPIRAZIN-2-IL)-N-ISOPROPILAMINO]BUTILOXI}N-(METILSULFONIL)ACETAMIDA, COMPOSICIONES FARMACEUTICAS QUE LAS CONTIENEN, METODO PARA PREPARARLAS Y USO DE LAS MISMAS EN EL TRATAMIENTO DE ISQUEMIAS, INSUFICIENCIA CORONARIA Y ASMA, ENTRE OTRAS ENFERMEDADES.
Estimated Expiration: ⤷ Sign Up
Patent: 1658
Patent: CRISTAL DE PIRAZINA Y COMPOSICIÓN FARMACÉUTICA
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Australia
Patent: 10263569
Patent: Crystals
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Patent: 16366073
Patent: Pharmaceutical composition containing 2-{4-[N-(5,6- diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N- (methylsulfonyl)acetamide
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 1015936
Patent: cristais
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Patent: 2018009534
Patent: composição farmacêutica contendo 2-{4-[n-(5,6-difenilpirazin-2-il)-n-isopropilamino]butiloxi }-n-(metilsulfonil)acetamida
Estimated Expiration: ⤷ Sign Up
Patent: 2021005510
Patent: Forma ii do cristal de 2-{4-[n-(5,6-difenilpirazin-2-il)-n isopropilamino]butilóxi}-n- metilsulfonil)acetamida e composição farmacêutica
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Canada
Patent: 64475
Patent: CRISTAUX (CRYSTALS)
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Patent: 05169
Patent: COMPOSITION SOLIDE STABILISEE CONTENANT 2-{4-[N-(5,6-DIPHENYLPYRAZINE-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY} (METHYLSULFONYLE)ACETAMIDE ET D-MANNITOL (STABILIZED SOLID COMPOSITION CONTAINING 2-{4-[N-(5,6-DIPHENYLPYRAZIN-2-Y)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(METHYLSULFONYL)ACETAMIDE AND D-MANNITOL)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11003264
Patent: Forma cristalina i de 2-{4-[n-(5,6-difenilpirazin-2-il)-n-isopropil-amino]butiloxi}-n-(metilsulfonil)acetamida, agonista del receptor de pgi2; metodo de preparacion, composicion farmaceutica, y uso para el tratamiento de hipertension, trombosis, nefropatia diabetica, asma bronquial, ulcera, entre otras.
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Patent: 18001464
Patent: Composición farmacéutica que contiene 2-{4-[n-(5,6-difenilpirazin-2-il)-n-isopropilamino]butiloxi}-n-(metilsulfonil)acetamida
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China
Patent: 2459198
Patent: Crystals
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Patent: 4326991
Patent: CRYSTALs
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Patent: 8289890
Patent: 含有2-{4-[N-(5,6-二苯基吡嗪-2-基)-N-异丙基氨基]丁氧基}-N-(甲磺酰基)乙酰胺的医药组合物 (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6-DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(METHYLSULFONYL)ACETAMIDE)
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Colombia
Patent: 30432
Patent: CRISTALES
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Patent: 18006834
Patent: Composición farmacéutica que contiene 2-{4-[n-(5,6-difenilpirazin-2-il)-n-isopropilamino]butiloxi}-n-(metilsulfonil)acetamida
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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
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Patent: 75871
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Ecuador
Patent: 18049108
Patent: COMPOSICIÓN FARMACÉUTICA QUE CONTIENE 2-{4-[N-(5,6-DIFENILPIRAZIN-2-IL)-N-ISOPROPILAMINO]BUTILOXI}-N-(METILSULFONIL)ACETAMIDA
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European Patent Office
Patent: 47254
Patent: CRISTAUX (CRYSTALS)
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Patent: 75871
Patent: CRISTAUX (CRYSTALS)
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Patent: 84911
Patent: COMPOSITION PHARMACEUTIQUE CONTENANT DE LA 2-{4-[N-(5,6-DIPHÉNYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(MÉTHYLSULFONYL)ACÉTAMIDE (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE)
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Patent: 89855
Patent: CRISTAUX (CRYSTALS)
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Patent: 31607
Patent: COMPOSITION PHARMACEUTIQUE CONTENANT DU 2-¢4-(N-(5,6-DIPHÉNYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO!BUTYLOXY}-N-(MÉTHYLSULFONYL)ACÉTAMIDE (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6-DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(METHYLSULFONYL)ACETAMIDE)
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Hong Kong
Patent: 44788
Patent: 晶體 (CRYSTALS)
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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
Patent: 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)
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Patent: 3287
Patent: צורה גבישית -ii- של 2-{4-[-n-(5,6-דיפנילפיראזין-2-יל)--n-איזופרופילאמינו]בוטילוקסי}-n-(מתילסולפוניל)אצטאמיד, הרכבים רוקחיים המכילים אותה והשימושים הטיפוליים שלה (Form-ii crystal of 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n-(methylsulfonyl)acetamide, pharmaceutical composition comprising it and it’s therapeutic uses)
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Patent: 9461
Patent: תכשיר רוקחות המכיל 2-{4-[n-(6,5-דיפנילפיראזין-2-איל)-n-איזופרופילאמינו]בוטילאוקסי}-n-(מתילסולפוניל)אצטאמיד (Pharmaceutical composition containing 2-{4-[n-(5,6- diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n- (methylsulfonyl)acetamide)
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Patent: 0203
Patent: תכשיר רוקחות המכיל 2-{4-[n-(6,5-דיפנילפיראזין-2-איל)-n-איזופרופילאמינו]בוטילאוקסי}-n-(מתילסולפוניל)אצטאמיד (Pharmaceutical composition containing 2-{4n-(5,6- diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n- (methylsulfonyl)acetamide)
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Japan
Patent: 2010150865
Patent: 結晶
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Patent: 2017098998
Patent: ２−｛４−［Ｎ−（５，６−ジフェニルピラジン−２−イル）−Ｎ−イソプロピルアミノ］ブチルオキシ｝−Ｎ−（メチルスルホニル）アセトアミドを含有する医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 25574
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 447254
Estimated Expiration: ⤷ Sign Up
Patent: 2018008
Estimated Expiration: ⤷ Sign Up
Patent: 47254
Estimated Expiration: ⤷ Sign Up
Patent: 75871
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6531
Patent: CRYSTALS
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Mexico
Patent: 6318
Patent: CRISTALES. (CRYSTALS.)
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Patent: 11013471
Patent: CRISTALES. (CRYSTALS.)
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Patent: 18006343
Patent: COMPOSICION FARMACEUTICA QUE CONTIENE 2-{4-[N-(5,6-DIFENILPIRAZIN- 2-IL)-N-ISOPROPILAMINO]BUTILOXI}-N-(METILSULFONIL)ACETAMIDA. (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE.)
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Morocco
Patent: 637
Patent: بلورات
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New Zealand
Patent: 7352
Patent: CRYSTALS of 2-{ 4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy} -N-(methylsulfonyl)acetamide
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Norway
Patent: 18015
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Patent: 47254
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Peru
Patent: 181072
Patent: COMPOSICION FARMACEUTICA QUE CONTIENE 2-{4-[N-(5,6-DIFENILPIRAZIN-2-IL)-N-ISOPROPILAMINO]BUTILOXI}-N-(METILSULFONIL)ACETAMIDA
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Philippines
Patent: 015502824
Patent: CRYSTALS
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Patent: 015502825
Patent: CRYSTALS
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Patent: 018501161
Patent: PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE
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Poland
Patent: 47254
Estimated Expiration: ⤷ Sign Up
Patent: 75871
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 47254
Estimated Expiration: ⤷ Sign Up
Patent: 75871
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Russian Federation
Patent: 56206
Patent: КРИСТАЛЛЫ (CRYSTALS)
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Patent: 35547
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ 2-{ 4-[N-(5,6-ДИФЕНИЛПИРАЗИН-2-ИЛ)-N-ИЗОПРОПИЛАМИНО]БУТИЛОКСИ} -N-(МЕТИЛСУЛЬФОНИЛ)АЦЕТАМИД (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6-DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(METHYLSULPHONYL)ACETAMIDE)
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Patent: 12102678
Patent: КРИСТАЛЛЫ
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Patent: 18123304
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ 2-{ 4-[N-(5,6-ДИФЕНИЛПИРАЗИН-2-ИЛ)-N-ИЗОПРОПИЛАМИНО]БУТИЛОКСИ} -N-(МЕТИЛСУЛЬФОНИЛ)АЦЕТАМИД
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Singapore
Patent: 6915
Patent: CRYSTALS
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Patent: 201403313W
Patent: CRYSTALS
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Patent: 201804320Q
Patent: PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE
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Slovenia
Patent: 47254
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Patent: 75871
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South Africa
Patent: 1109099
Patent: CRYSTALS
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Patent: 1804387
Patent: PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE
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South Korea
Patent: 120109457
Patent: CRYSTALS
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Patent: 170024165
Patent: 결정 (CRYSTALS)
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Patent: 180081141
Patent: 2-｛4-[N--N-이소프로필아미노]부틸옥시｝-N-아세트아미드를 함유하는 의약 조성물
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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
Patent: Crystal
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Patent: 1720444
Patent: Pharmaceutical composition containing 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n-(methylsulfonyl)acetamide
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Ukraine
Patent: 8849
Patent: КРИСТАЛІЧНА ФОРМА 2-{4-[N-(5,6-ДИФЕНІЛПІРАЗИН-2-ІЛ)-N-ІЗОПРОПІЛАМІНО]БУТИЛОКСИ}-N-(МЕТИЛСУЛЬФОНІЛ)АЦЕТАМІДУ
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Patent: 4002
Patent: ТВЕРДИЙ ПРЕПАРАТ, ЩО МІСТИТЬ 2-{4-[N-(5,6- ДИФЕНІЛПІРАЗИН-2-ІЛ)-N-ІЗОПРОПІЛАМІНО]БУТИЛОКСИ}-N-(МЕТИЛСУЛЬФОНІЛ)АЦЕТАМІД (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE)
Estimated Expiration: ⤷ Sign Up
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 | E047767 | ⤷ Sign Up | |
| Spain | 2660007 | ⤷ Sign Up | |
| Brazil | PI0209249 | agonista de receptor de pgi2, inibidor de agregacao de plaqueta, agentes terapeuticos e derivados de composto heterociclico | ⤷ 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 | 93266 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519 |
| 2447254 | PA2018008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512 |
| 1400518 | 44/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 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.
ISSN: 2162-2639
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