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BELVIQ XR Drug Profile
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» See Plans and PricingWhen 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
Summary for BELVIQ XR
| International Patents: | 211 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 23 |
| 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 |
Recent Clinical Trials for BELVIQ XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Drug Abuse (NIDA) | Early Phase 1 |
| New York State Psychiatric Institute | Early Phase 1 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
Recent Litigation for BELVIQ XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Arena Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-03-06 |
| Arena Pharmaceuticals Inc. v. Lupin Ltd. | 2016-09-30 |
Pharmacology for BELVIQ XR
| Drug Class | Serotonin-2c Receptor Agonist |
| Mechanism of Action | Serotonin 2c Receptor Agonists Cytochrome P450 2D6 Inhibitors |
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 |
International Patents for BELVIQ XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2886875 | Start Trial |
| South Korea | 20190128001 | Start Trial |
| Mexico | 2015004532 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
