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UPTRAVI Drug Profile
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See Plans and PricingWhen do Uptravi patents expire, and when can generic versions of Uptravi launch?
Uptravi is a drug marketed by Actelion Pharms Ltd and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred patent family members in thirty-three 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.
US ANDA Litigation and 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.
Indicators of Generic Entry
Summary for UPTRAVI
| International Patents: | 100 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 2 |
| Patent Applications: | 35 |
| Drug Prices: | Drug price information for UPTRAVI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for UPTRAVI |
| DailyMed Link: | UPTRAVI at DailyMed |
Generic Entry Opportunity Date for UPTRAVI
Generic Entry Date for UPTRAVI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 3 |
| Actelion | Phase 4 |
Recent Litigation for UPTRAVI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NIPPON SHINYAKU CO., LTD. v. KAPPOS | 2010-07-06 |
Pharmacology for UPTRAVI
| Drug Class | Prostacyclin Receptor Agonist |
| Mechanism of Action | Prostacyclin Receptor Agonists |
Synonyms for UPTRAVI
| 144383-EP2289518A1 |
| 144383-EP2292231A1 |
| 2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-N-(methylsulfonyl)acetamide |
| 2-(4-((5,6-Diphenylpyrazin-2-yl)(propan-2-yl)amino)butoxy}-n-(methanesulfonyl)acetamide |
| 2-(4-((5,6-Diphenylpyrazinyl)(1-methylethyl)amino)butoxy)-N-(methylsulfonyl)-acetamide |
| 2-[4-[(5,6-Diphenyl-2-pyrazinyl)(1-methylethyl)amino]butoxy]-N-(methylsulfonyl)acetamide |
| 2-[4-[[5,6-di(phenyl)pyrazin-2-yl]-propan-2-ylamino]butoxy]-N-methylsulfonylacetamide |
| 2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-(methanesulfonyl)acetamide |
| 2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-methanesulfonylacetamide |
| 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide |
| 3938AH |
| 475086-01-2 |
| 5EXC0E384L |
| AC-30209 |
| ACT 293987 |
| ACT-293987 |
| AK298890 |
| AKOS024457572 |
| B7378 |
| BCP09146 |
| CHEBI:90844 |
| CHEMBL238804 |
| CS-3774 |
| CTK8F0123 |
| D09994 |
| DB11362 |
| GTPL7552 |
| HY-14870 |
| KB-79567 |
| KS-00000L89 |
| MolPort-009-019-323 |
| NCGC00370833-01 |
| NS 304 |
| NS 304; ACT 293987; Uptravi |
| NS-304 |
| NS-304(Selexipag) |
| QXWZQTURMXZVHJ-UHFFFAOYSA-N |
| RT-014761 |
| SB17055 |
| SCHEMBL674122 |
| Selexipag |
| Selexipag (JAN/USAN/INN) |
| Selexipag [USAN:INN] |
| Selexipag(NS-304) |
| UNII-5EXC0E384L |
| Uptravi (TN) |
| ZINC3990451 |
US Patents and Regulatory Information for UPTRAVI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion Pharms Ltd | UPTRAVI | selexipag | TABLET;ORAL | 207947-007 | Dec 21, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | UPTRAVI | selexipag | TABLET;ORAL | 207947-006 | Dec 21, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | UPTRAVI | selexipag | TABLET;ORAL | 207947-008 | Dec 21, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Actelion Pharms Ltd | UPTRAVI | selexipag | TABLET;ORAL | 207947-005 | Dec 21, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 |
|---|---|---|
| China | 102459198 | Start Trial |
| Spain | 2660007 | Start Trial |
| Australia | 2009280843 | Start Trial |
| Mexico | 2011013471 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UPTRAVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1400518 | 16C0042 | France | Start Trial | PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519 |
| 1400518 | 300836 | Netherlands | Start Trial | PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519 |
| 1400518 | 2016/047 | Ireland | Start Trial | PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512 |
| 1400518 | 1690044-1 | Sweden | Start Trial | PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
