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Last Updated: January 28, 2021

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BELVIQ XR Drug Profile

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When do Belviq Xr patents expire, and what generic alternatives are available?

Belviq Xr is a drug marketed by Eisai Inc and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in BELVIQ XR 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 Xr

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 31, 2031. This may change due to patent challenges or generic licensing.

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 XR
Drug Prices for BELVIQ XR

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Generic Entry Opportunity Date for BELVIQ XR
Generic Entry Date for BELVIQ XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BELVIQ XR

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

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 XR clinical trials

Paragraph IV (Patent) Challenges for BELVIQ XR
Tradename Dosage Ingredient NDA Submissiondate
BELVIQ XR TABLET, EXTENDED RELEASE;ORAL lorcaserin hydrochloride 208524 2016-12-13

US Patents and Regulatory Information for BELVIQ XR

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 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   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   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   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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