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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 one Paragraph IV challenge.
This drug has one hundred and forty-two patent family members in thirty-seven 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: | 142 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 3 |
| Patent Applications: | 284 |
| 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 ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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 it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
Heterocyclic compound derivatives and medicines
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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 it Free
Patent Expiration: ⤷ Try it Free
Therapeutic compositions containing macitentan
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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 it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-004 | Dec 21, 2015 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-007 | Dec 21, 2015 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-008 | Dec 21, 2015 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Actelion | UPTRAVI | selexipag | TABLET;ORAL | 207947-006 | Dec 21, 2015 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for UPTRAVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2012102678 | ⤷ Try it Free |
| Spain | 2797124 | ⤷ Try it Free |
| Hungary | E036721 | ⤷ Try it Free |
| Japan | 5956025 | ⤷ Try it Free |
| Russian Federation | 2556206 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UPTRAVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2447254 | 325 10-2018 | Slovakia | ⤷ Try it Free | PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519 |
| 1400518 | 300836 | Netherlands | ⤷ Try it Free | PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519 |
| 1400518 | 132016000106856 | Italy | ⤷ Try it Free | PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519 |
| 2447254 | 2018015 | Norway | ⤷ Try it Free | PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530 |
| 1400518 | 532 | Finland | ⤷ Try it Free | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
