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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

Summary for BELVIQ XR

International Patents:	212
US Patents:	17
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	25
Patent Applications:	34
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BELVIQ XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELVIQ XR
DailyMed Link:	BELVIQ XR at DailyMed

See drug prices for BELVIQ XR

Generic Entry Opportunity Date for BELVIQ XR

NDA:

208524

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

Sponsor	Phase
The Mind Research Network	Phase 2
New York State Psychiatric Institute	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1

See all BELVIQ XR clinical trials

Pharmacology for BELVIQ XR

Drug Class	Serotonin-2c Receptor Agonist
Mechanism of Action	Serotonin 2c Receptor Agonists Cytochrome P450 2D6 Inhibitors

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

International Patents for BELVIQ XR

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03086306
Poland	231405
South Korea	20140091458
South Korea	101281919
Japan	6272695
Japan	2014156490