VELETRI Drug Patent Profile
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When do Veletri patents expire, and what generic alternatives are available?
Veletri is a drug marketed by Actelion 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 MEITHEAL on April 23rd, 2008.
Summary for VELETRI
| International Patents: | 19 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,188 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for VELETRI
Paragraph IV (Patent) Challenges for VELETRI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VELETRI | Injection | epoprostenol sodium | 0. 5m/vial and 1.5 mg/vial | 022260 | 1 | 2017-03-31 |
US Patents and Regulatory Information for VELETRI
VELETRI is protected by two US patents.
Patents protecting VELETRI
Epoprostenol formulation and method of making thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Epoprostenol formulation and method of making thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actelion | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-002 | Jun 28, 2012 | AP2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Actelion | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-001 | Jun 27, 2008 | AP2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Actelion | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-002 | Jun 28, 2012 | AP2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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
See the table below for patents covering VELETRI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2008135701 | КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ | ⤷ Try a Trial |
| South Korea | 101351668 | ⤷ Try a Trial | |
| Canada | 2641393 | NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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