HABITROL Drug Patent Profile

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When do Habitrol patents expire, and when can generic versions of Habitrol launch?

Habitrol is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Habitrol

A generic version of HABITROL was approved as nicotine by AVEVA on October 20^th, 1997.

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Summary for HABITROL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	11
Patent Applications:	3,162
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in HABITROL?	HABITROL excipients list
DailyMed Link:	HABITROL at DailyMed

Drug patent expirations by year for HABITROL

Recent Clinical Trials for HABITROL

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

Sponsor	Phase
NYU Langone Health	Phase 1
University of Virginia	N/A
Ohio State University	Phase 1/Phase 2

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Pharmacology for HABITROL

Drug Class	Cholinergic Nicotinic Agonist

Anatomical Therapeutic Chemical (ATC) Classes for HABITROL

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for HABITROL

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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
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-006	Nov 12, 1999		OTC	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

Expired US Patents for HABITROL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for HABITROL

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	0246385	TRANSCUTANEOUS APPLICATION OF NICOTINE	⤷ Try a Trial
Austria	143277		⤷ Try a Trial
Mexico	9203535	METODO Y APARATO PARA AYUDAR A LA REDUCCION DE LA INCIDENCIA DE FUMAR TABACO.	⤷ Try a Trial
Germany	498468		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for HABITROL

Recent Clinical Trials for HABITROL

Pharmacology for HABITROL

Anatomical Therapeutic Chemical (ATC) Classes for HABITROL

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