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 HONG KONG 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 | |||
Actelion | VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260-001 | Jun 27, 2008 | AP2 | RX | Yes | Yes | ⤷ 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 |
---|---|---|---|
Denmark | 1993557 | ⤷ Try a Trial | |
Portugal | 1993557 | ⤷ Try a Trial | |
Canada | 2868998 | NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF) | ⤷ 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 |
World Intellectual Property Organization (WIPO) | 2007092343 | ⤷ Try a Trial | |
Spain | 2558705 | ⤷ Try a Trial | |
European Patent Office | 1993557 | 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 |