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 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for SIBUTRAMINE HYDROCHLORIDE
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 | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
Abbott | MERIDIA | sibutramine hydrochloride | CAPSULE;ORAL | 020632-003 | Nov 22, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |