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Last Updated: August 8, 2020

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BELVIQ Drug Profile

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Which patents cover Belviq, and when can generic versions of Belviq launch?

Belviq is a drug marketed by Eisai Inc and is included in two NDAs. There are seventeen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ninety patent family members in forty-two countries.

The generic ingredient in BELVIQ is lorcaserin hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lorcaserin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Belviq

Belviq was eligible for patent challenges on June 27, 2016.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (lorcaserin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for BELVIQ
Drug Prices for BELVIQ

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Recent Clinical Trials for BELVIQ

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SponsorPhase
The Mind Research NetworkPhase 2
New York State Psychiatric InstituteEarly Phase 1
National Institute on Drug Abuse (NIDA)Early Phase 1

See all BELVIQ clinical trials

Paragraph IV (Patent) Challenges for BELVIQ
Tradename Dosage Ingredient NDA Submissiondate
BELVIQ TABLET;ORAL lorcaserin hydrochloride 022529 2020-06-27
BELVIQ TABLET;ORAL lorcaserin hydrochloride 022529 2019-06-27

US Patents and Regulatory Information for BELVIQ

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 Y Y   Start Trial
Eisai Inc BELVIQ XR lorcaserin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208524-001 Jul 15, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Eisai Inc BELVIQ XR lorcaserin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208524-001 Jul 15, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc BELVIQ XR lorcaserin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208524-001 Jul 15, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc BELVIQ XR lorcaserin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208524-001 Jul 15, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   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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