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VELETRI Drug Profile
» See Plans and Pricing
When do Veletri patents expire, and what generic alternatives are available?
Veletri is a drug marketed by Actelion Pharms Ltd and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has nineteen patent family members in fifteen countries.
The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Veletri
A generic version of VELETRI was approved as epoprostenol sodium by TEVA PHARMS USA on April 23rd, 2008.
Summary for VELETRI
| International Patents: | 19 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 1 |
| Patent Applications: | 653 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VELETRI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VELETRI |
| What excipients (inactive ingredients) are in VELETRI? | VELETRI excipients list |
| DailyMed Link: | VELETRI at DailyMed |
Recent Clinical Trials for VELETRI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 4 |
Pharmacology for VELETRI
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Paragraph IV (Patent) Challenges for VELETRI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELETRI | INJECTABLE;INJECTION | epoprostenol sodium | 022260 | 2017-03-31 |
US Patents and Regulatory Information for VELETRI
| 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 | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-002 | Jun 28, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-001 | Jun 27, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Actelion Pharms Ltd | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-002 | Jun 28, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Actelion Pharms Ltd | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-001 | Jun 27, 2008 | RX | Yes | Yes | Start Trial | Start Trial | 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 VELETRI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2423130 | Start Trial |
| Japan | 5415771 | Start Trial |
| China | 101410119 | Start Trial |
| Japan | 2009525344 | Start Trial |
| Poland | 1993557 | Start Trial |
| Portugal | 1993557 | Start Trial |
| Denmark | 1993557 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
