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Last Updated: June 2, 2020

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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 eleven 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.

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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Recent Clinical Trials for BELVIQ XR

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

SponsorPhase
National Institute on Drug Abuse (NIDA)Early Phase 1
New York State Psychiatric InstituteEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 1

See all BELVIQ XR clinical trials

Recent Litigation for BELVIQ XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Arena Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-06
Arena Pharmaceuticals Inc. v. Lupin Ltd.2016-09-30

See all BELVIQ XR litigation

Synonyms for BELVIQ XR
(1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride
(1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate
(1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride--water (2/1)
(1R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepinium chloride
(1R)-8-Chloro-2,3,4,5-tetrahydro-1-methyl-1H-3-benzazepine hydrochloride
(R)-1h-3-benzazepine,8-chloro-2,3,4,5-tetrahydro-1-methyl-,hydrochloride
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hemihydrate hydrochloride
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride hemihydrate
(r)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1h-3-benzazepine hydrochloride salt
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride salt hemihydrate
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-benzo[d]azepine hydrochloride
(R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-benzo[d]azepine hydrochloride hemihydrate
0QJF08GDPE
1H-3-Benzazepine, 8-chloro-2,3,4,5-tetrahydro-1-methyl-, hydrochloride (1:1), (1R)-
1H-3-Benzazepine, 8-chloro-2,3,4,5-tetrahydro-1-methyl-, hydrochloride, hydrate (2:2:1), (1R)-
1H-3-Benzazepine, 8-chloro-2,3,4,5-tetrahydro-1-methyl-,hydrochloride, (1R)-
846589-98-8
856681-05-5
AB0080320
AC-28981
AC-8945
ACN-034447
ACN-036083
ACT10402
AK142745
AKOS005145786
AOB87116
APD 356
APD-356
APD356
BCP22731
BCP9000859
Belviq
Belviq (TN)
CHEBI:65350
CHEBI:66852
CHEMBL2095211
CS-0752
D06613
D11566
DTXSID60233650
EX-A1697
FT-0696346
FT-0699079
HY-15368
ITIHHRMYZPNGRC-QRPNPIFTSA-N
KS-0000006Z
KS-1439
Lorcaserin (Hydrochloride)
Lorcaserin HCl
Lorcaserin hydrochloride
Lorcaserin hydrochloride (USAN)
Lorcaserin hydrochloride [USAN]
Lorcaserin hydrochloride hemihydrate
Lorcaserin hydrochloride(APD-356)
Lorqess
Q27135478
Q27888442
QC-9041
REV26SR2B4
SCHEMBL173899
ST24035516
SW219573-1
UNII-0QJF08GDPE
UNII-REV26SR2B4
W-5408
WRZCAWKMTLRWPR-VSODYHHCSA-N
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 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Harvard Business School
Medtronic
Mallinckrodt
Moodys

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