SIBUTRAMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for sibutramine hydrochloride and what is the scope of freedom to operate?

Sibutramine hydrochloride is the generic ingredient in one branded drug marketed by Abbott and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for sibutramine hydrochloride.

Summary for SIBUTRAMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	38
Patent Applications:	6,557
DailyMed Link:	SIBUTRAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for SIBUTRAMINE HYDROCHLORIDE

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2
University of Calgary	Phase 4

See all SIBUTRAMINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SIBUTRAMINE HYDROCHLORIDE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SIBUTRAMINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MERIDIA	Capsules	sibutramine hydrochloride	10 mg and 15 mg	020632	1	2009-08-14

US Patents and Regulatory Information for SIBUTRAMINE HYDROCHLORIDE

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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
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997		DISCN	No	No	⤷ 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

Expired US Patents for SIBUTRAMINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-002	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-003	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
Abbott	MERIDIA	sibutramine hydrochloride	CAPSULE;ORAL	020632-001	Nov 22, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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