Veletri Patent Expiration

Veletri is a drug owned by Actelion Pharmaceuticals Us Inc. It is protected by 2 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2027. Details of Veletri's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8598227 Epoprostenol formulation and method of making thereof
Feb, 2027

(2 years from now)

Active
US8318802 Epoprostenol formulation and method of making thereof
Mar, 2027

(2 years from now)

Active

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Several oppositions have been filed on Veletri'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 Veletri's generic, the next section provides detailed information on ongoing and past EP oppositions related to Veletri patents.

Veletri's oppositions filed in EPO

Veletri has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 11, 2016, by Generics (U.K.) Limited. This opposition was filed on patent number EP07763188A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07763188A Aug, 2016 Generics (U.K.) Limited Revoked


US patents provide insights into the exclusivity only within the United States, but Veletri 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 Veletri's family patents as well as insights into ongoing legal events on those patents.

Veletri's family patents

Veletri has patent protection in a total of 15 countries. It's US patent count contributes only to 40.0% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Veletri.

Family Patents

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Generic Launch

Generic Release Date:

Veletri's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 15, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Veletri Generics:

Epoprostenol Sodium is the generic name for the brand Veletri. 3 different companies have already filed for the generic of Veletri, with Meitheal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Veletri's generic

How can I launch a generic of Veletri before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Veletri's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Veletri'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 Veletri -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0. 5m/vial and 1.5 mg/vial 31 Mar, 2017 1 15 Jan, 2021 15 Mar, 2027 Deferred




About Veletri

Veletri is a drug owned by Actelion Pharmaceuticals Us Inc. Veletri uses Epoprostenol Sodium as an active ingredient. Veletri was launched by Actelion in 2012.

Market Authorisation Date:

Veletri was approved by FDA for market use on 28 June, 2012.

Active Ingredient:

Veletri uses Epoprostenol Sodium as the active ingredient. Check out other Drugs and Companies using Epoprostenol Sodium ingredient

Dosage:

Veletri is available in injectable form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 1.5MG BASE/VIAL INJECTABLE Prescription INJECTION
EQ 0.5MG BASE/VIAL INJECTABLE Prescription INJECTION