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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 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:	51
Clinical Trials:	22
Patent Applications:	31
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELVIQ XR
DailyMed Link:	BELVIQ XR at DailyMed

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			Y	Y
Eisai Inc	BELVIQ XR	lorcaserin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208524-001	Jul 15, 2016		RX	Yes	Yes			Y	Y
Eisai Inc	BELVIQ XR	lorcaserin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208524-001	Jul 15, 2016		RX	Yes	Yes			Y	Y
Eisai Inc	BELVIQ XR	lorcaserin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208524-001	Jul 15, 2016		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for BELVIQ XR

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	20 mg		2016-12-13

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
8,846,906	5HT.sub.2C receptor modulators
7,704,993	Benzazepine derivatives and methods of prophylaxis or treatment of 5ht2c receptor associated diseases
8,404,675	Benzazepine derivatives and methods of prophylaxis or treatment of 5HT2C receptor associated diseases
9,102,627	Processes for preparing 3-benzazepines

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International Patents for BELVIQ XR

Country	Document Number	Estimated Expiration
Cyprus	1117619
Japan	4782003
Japan	2005527579
Singapore	188365