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Last Updated: March 19, 2024

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.

Recent Clinical Trials for sibutramine hydrochloride

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

SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudePhase 2
University of CalgaryPhase 4

See all sibutramine hydrochloride clinical trials

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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott MERIDIA sibutramine hydrochloride CAPSULE;ORAL 020632-001 Nov 22, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott MERIDIA sibutramine hydrochloride CAPSULE;ORAL 020632-003 Nov 22, 1997 DISCN No No ⤷  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 sibutramine hydrochloride

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.