Uptravi is a drug owned by Actelion Pharmaceuticals Us Inc. It is protected by 6 US drug patents filed from 2016 to 2021 out of which none have expired yet. Uptravi's patents have been open to challenges since 22 December, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2036. Details of Uptravi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8791122 | Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide and method for producing the same |
Aug, 2030
(4 years from now) | Active |
| US7205302 | Heterocyclic compound derivatives and medicines |
Oct, 2026
(11 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10828298 | Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsulfonyl)acetamide |
Dec, 2036
(11 years from now) | Active |
| US10821108 | Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide |
Dec, 2036
(11 years from now) | Active |
| US9284280 | Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide |
Jun, 2030
(4 years from now) | Active |
| US9173881 | Therapeutic compositions containing macitentan |
Aug, 2029
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Uptravi's patents.
Latest Legal Activities on Uptravi's Patents
Given below is the list of recent legal activities going on the following patents of Uptravi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Apr, 2024 | US10828298 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Apr, 2024 | US10821108 |
| Court Processing Terminated | 02 Apr, 2024 | US7205302 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2023 | US9284280 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Apr, 2023 | US9173881 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jan, 2022 | US8791122 |
| Patent Term Extension Certificate
Critical | 12 Nov, 2021 | US7205302 |
| Notice of Final Determination -Eligible | 09 Mar, 2021 | US7205302 |
| Case Docketed to Examiner in GAU
Critical | 06 Jan, 2021 | US7205302 |
| Patent Issue Date Used in PTA Calculation
Critical | 10 Nov, 2020 | US10828298 |
FDA has granted several exclusivities to Uptravi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Uptravi, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Uptravi.
Exclusivity Information
Uptravi holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Uptravi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 21, 2020 |
| Orphan Drug Exclusivity(ODE) | Dec 21, 2022 |
| Orphan Drug Exclusivity(ODE-106) | Dec 21, 2022 |
Several oppositions have been filed on Uptravi's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Uptravi's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Uptravi patents.
Uptravi's Oppositions Filed in EPO
Uptravi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 19, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP09786912A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17186415A | Oct, 2020 | Generics [UK] Limited | Granted and Under Opposition |
| EP17191033A | Jul, 2020 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP17191033A | Jul, 2020 | Generics (UK) Ltd | Granted and Under Opposition |
| EP17191033A | Jul, 2020 | Aera A/S | Granted and Under Opposition |
| EP10792183A | Sep, 2018 | Hexal AG | Granted and Under Opposition |
| EP10792183A | Sep, 2018 | Generics [UK] Ltd | Granted and Under Opposition |
| EP10792183A | Sep, 2018 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP09786912A | Jul, 2018 | Hexal AG | Granted and Under Opposition |
| EP09786912A | Jul, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09786912A | Jul, 2018 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP09786912A | Jul, 2018 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP09786912A | Jul, 2018 | Generics (UK) Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Uptravi is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Uptravi's family patents as well as insights into
ongoing legal events
on those patents.
Uptravi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Uptravi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Uptravi Generic API suppliers:
Selexipag is the generic name for the brand Uptravi. 2 different companies have already filed for the generic of Uptravi, with Zydus Lifesciences having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Uptravi's generic
How can I launch a generic of Uptravi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Uptravi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Uptravi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Uptravi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg | 23 Dec, 2019 | 4 | 21 Dec, 2022 | 01 Aug, 2030 | Eligible |
| 1.8 mg/vial | 29 Jul, 2022 | 1 | 01 Aug, 2030 |
About Uptravi
Uptravi is a drug owned by Actelion Pharmaceuticals Us Inc. It is used for treating pulmonary arterial hypertension. Uptravi uses Selexipag as an active ingredient. Uptravi was launched by Actelion in 2015.
Approval Date:
Uptravi was approved by FDA for market use on 21 December, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Uptravi is 21 December, 2015, its NCE-1 date is estimated to be 22 December, 2019.
Active Ingredient:
Uptravi uses Selexipag as the active ingredient. Check out other Drugs and Companies using Selexipag ingredient
Treatment:
Uptravi is used for treating pulmonary arterial hypertension.
Dosage:
Uptravi is available in the following dosage forms - powder form for intravenous use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2MG | TABLET | Prescription | ORAL |
| 1.6MG | TABLET | Prescription | ORAL |
| 1.4MG | TABLET | Prescription | ORAL |
| 1.2MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 0.4MG | TABLET | Prescription | ORAL |
| 0.8MG | TABLET | Prescription | ORAL |
| 0.6MG | TABLET | Prescription | ORAL |
| 1.8MG/VIAL | POWDER | Prescription | INTRAVENOUS |