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Last Updated: November 28, 2020

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Lorcaserin hydrochloride - Generic Drug Details

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What are the generic sources for lorcaserin hydrochloride and what is the scope of patent protection?

Lorcaserin hydrochloride is the generic ingredient in two branded drugs marketed by Eisai Inc and is included in two NDAs. There are seventeen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lorcaserin hydrochloride has two hundred and eleven patent family members in forty-two countries.

There are five drug master file entries for lorcaserin hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for lorcaserin hydrochloride

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

SponsorPhase
Eisai Inc.Phase 3
National Cancer Institute (NCI)Phase 1
Ohio State University Comprehensive Cancer CenterPhase 1

See all lorcaserin hydrochloride clinical trials

Generic filers with tentative approvals for LORCASERIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lorcaserin hydrochloride
Paragraph IV (Patent) Challenges for LORCASERIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BELVIQ TABLET;ORAL lorcaserin hydrochloride 022529 2020-06-27
BELVIQ TABLET;ORAL lorcaserin hydrochloride 022529 2019-06-27
BELVIQ XR TABLET, EXTENDED RELEASE;ORAL lorcaserin hydrochloride 208524 2016-12-13

US Patents and Regulatory Information for lorcaserin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc BELVIQ lorcaserin hydrochloride TABLET;ORAL 022529-001 Jun 27, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc BELVIQ lorcaserin hydrochloride TABLET;ORAL 022529-001 Jun 27, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc BELVIQ lorcaserin hydrochloride TABLET;ORAL 022529-001 Jun 27, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc BELVIQ lorcaserin hydrochloride TABLET;ORAL 022529-001 Jun 27, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Medtronic
AstraZeneca
McKesson
Baxter

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