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BELVIQ XR Drug Profile
» See Plans and Pricing
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 |


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
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 |
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 | 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 |
International Patents for BELVIQ XR
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 03086306 | Start Trial |
Poland | 231405 | Start Trial |
South Korea | 20140091458 | Start Trial |
South Korea | 101281919 | Start Trial |
Japan | 6272695 | Start Trial |
Japan | 2014156490 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |