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. Four 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 23^rd, 2008.

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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
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

Drug patent expirations by year for VELETRI

Recent Clinical Trials for VELETRI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Duke University	Phase 4

See all VELETRI clinical trials

Pharmacology for VELETRI

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1993557	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)	⤷ Sign Up
Japan	5415771		⤷ Sign Up
South Korea	101351668		⤷ Sign Up
Canada	2641393	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)	⤷ Sign Up
Japan	2009525344		⤷ Sign Up
Cyprus	1117128		⤷ Sign Up
Russian Federation	2423130	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (EPOPROSTENOL-CONTAINING COMPOSITION AND METHOD OF ITS OBTAINING)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration