OLEPTRO Drug Patent Profile

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Which patents cover Oleptro, and when can generic versions of Oleptro launch?

Oleptro is a drug marketed by Angelini Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in thirty countries.

The generic ingredient in OLEPTRO is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oleptro

A generic version of OLEPTRO was approved as trazodone hydrochloride by APOTEX on March 25^th, 1987.

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Summary for OLEPTRO

International Patents:	78
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	8
Patent Applications:	1,664
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLEPTRO
DailyMed Link:	OLEPTRO at DailyMed

Drug patent expirations by year for OLEPTRO

Recent Clinical Trials for OLEPTRO

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

Sponsor	Phase
Louis Stokes VA Medical Center	Phase 1
VA Connecticut Healthcare System	Phase 4
Algorithme Pharma Inc	Phase 1

See all OLEPTRO clinical trials

Paragraph IV (Patent) Challenges for OLEPTRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLEPTRO	Extended-release Tablets	trazodone hydrochloride	150 mg and 300 mg	022411	1	2010-10-18

US Patents and Regulatory Information for OLEPTRO

OLEPTRO is protected by two US patents.

Patents protecting OLEPTRO

Trazodone composition for once a day administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DEPRESSION

Trazodone and trazodone hydrochloride in purified form
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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
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OLEPTRO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OLEPTRO

See the table below for patents covering OLEPTRO around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2010535170		⤷ Sign Up
Japan	5269595		⤷ Sign Up
South Korea	101505522		⤷ Sign Up
European Patent Office	1305009	AMIDON RETICULE A FORTE TENEUR EN AMYLOSE POUVANT ETRE UTILISE DANS DES PREPARATIONS PHARMACEUTIQUE A LIBERATION PROLONGEE ET PROCEDES DE FABRICATION ASSOCIES (CROSS-LINKED HIGH AMYLOSE STARCH FOR USE IN CONTROLLED-RELEASE PHARMACEUTICAL FORMULATIONS AND PROCESSES FOR ITS MANUFACTURE)	⤷ Sign Up
Poland	202177		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration