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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8318802 | Epoprostenol formulation and method of making thereof |
Mar, 2027
(2 years from now) | Active |
| US8598227 | Epoprostenol formulation and method of making thereof |
Feb, 2027
(2 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 Veletri's patents.
Latest Legal Activities on Veletri's Patents
Given below is the list of recent legal activities going on the following patents of Veletri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 May, 2024 | US8318802 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2021 | US8598227 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 May, 2020 | US8318802 |
| Email Notification Critical | 05 Sep, 2014 | US8598227 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Sep, 2014 | US8598227 |
| Filing Receipt - Replacement | 05 Sep, 2014 | US8598227 |
| Electronic Review Critical | 23 Jul, 2014 | US8598227 |
| Email Notification Critical | 23 Jul, 2014 | US8598227 |
| Mail Pre-Exam Notice | 23 Jul, 2014 | US8598227 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Jul, 2014 | US8318802 |
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 |
|---|---|---|---|
 | |||
| 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
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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 Generic API suppliers:
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.
Approval 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 |