DrugPatentWatch Database Preview
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 fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and seventy-six patent family members in forty-one 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.
Summary for BELVIQ XR
| International Patents: | 176 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 22 |
| Patent Applications: | 31 |
| 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
*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.
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-benzazepinium chloride |
| (1R)-8-Chloro-2,3,4,5-tetrahydro-1-methyl-1H-3-benzazepine hydrochloride |
| (5R)-7-chloro-5-methyl-2,3,4,5-tetrahydro-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 hydrochloride |
| (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-benzo[d]azepine hydrochloride |
| (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-benzo[d]azepine hydrochloride hemihydrate |
| 0QJF08GDPE |
| 846589-98-8 |
| AB0080320 |
| AC-8945 |
| ACT10402 |
| AK142745 |
| AKOS005145786 |
| AN-7508 |
| AOB87116 |
| APD-356 |
| BC224447 |
| BCP9000859 |
| Belviq |
| Belviq (TN) |
| CHEBI:65350 |
| CHEMBL2095211 |
| CS-0752 |
| D06613 |
| DTXSID60233650 |
| EX-A1697 |
| FT-0696346 |
| HY-15368 |
| ITIHHRMYZPNGRC-QRPNPIFTSA-N |
| KS-0000006Z |
| KS-1439 |
| Lorcaserin (Hydrochloride) |
| Lorcaserin HCl |
| Lorcaserin hydrochloride |
| Lorcaserin hydrochloride (USAN) |
| Lorcaserin hydrochloride [USAN] |
| Lorcaserin hydrochloride(APD-356) |
| Lorqess |
| MFCD09833667 |
| MolPort-005-942-404 |
| QC-9041 |
| SCHEMBL173899 |
| ST24035516 |
| UNII-0QJF08GDPE |
| W-5408 |
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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Eisai Inc | BELVIQ XR | lorcaserin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208524-001 | Jul 15, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Eisai Inc | BELVIQ XR | lorcaserin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208524-001 | Jul 15, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Eisai Inc | BELVIQ XR | lorcaserin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208524-001 | Jul 15, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Eisai Inc | BELVIQ XR | lorcaserin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208524-001 | Jul 15, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| 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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Paragraph IV (Patent) Challenges for BELVIQ XR
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Tablets | 20 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for BELVIQ XR
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,704,993 | Benzazepine derivatives and methods of prophylaxis or treatment of 5ht2c receptor associated diseases | ➤ Sign Up |
| 8,846,906 | 5HT.sub.2C receptor modulators | ➤ Sign Up |
| 8,404,675 | Benzazepine derivatives and methods of prophylaxis or treatment of 5HT2C receptor associated diseases | ➤ Sign Up |
| 9,102,627 | Processes for preparing 3-benzazepines | ➤ Sign Up |
| 8,993,750 | 5HT.sub.2C receptor modulators | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for BELVIQ XR
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200400037 | ➤ Sign Up |
| New Zealand | 608266 | ➤ Sign Up |
| European Patent Office | 1838677 | ➤ Sign Up |
| Spain | 2571220 | ➤ Sign Up |
| Slovenia | 2332921 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
