Belviq Xr Patent Expiration

Belviq Xr is a drug owned by Eisai Inc. It is protected by 17 US drug patents filed from 2016 to 2019. Out of these, 8 drug patents are active and 9 have expired. Belviq Xr's patents have been open to challenges since 27 June, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 07, 2033. Details of Belviq Xr's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8168624 Crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride
Apr, 2029

(4 years from now)

Active
US8697686 Crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-thtrahydro-1H-3-benzazepine hydrochloride
Dec, 2025

(1 year, 5 days from now)

Active
US8367657 Processes for preparing 3-benzazepines
Apr, 2023

(1 year, 8 months ago)

Expired
US6953787 5HT2C receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
US8546379 5HT2C receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
US7977329 5HT2C receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8999970 Administration of an anti-obesity compound to individuals with renal impairment
Feb, 2033

(8 years from now)

Active
US9169213 Method of weight management
Dec, 2032

(7 years from now)

Active
US10226471 Modified-release dosage forms of 5-HT2C agonists useful for weight management
Aug, 2031

(6 years from now)

Active
US10463676 Modified-release dosage forms of 5-HT2C agonists useful for weight management
Aug, 2031

(6 years from now)

Active
US9770455 Administration of an anti-obesity compound to individuals with renal impairment
Aug, 2031

(6 years from now)

Active
US8980881 Crystalline forms of (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine hydrochloride
Dec, 2025

(1 year, 5 days from now)

Active
US8946207 Processes for preparing 3-benzazepines
Jun, 2024

(5 months ago)

Expired
US8273734 5HT2C receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
US7514422 5HT2c receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
US8575149 5HT2C receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired
US8207158 5HT2c receptor modulators
Apr, 2023

(1 year, 8 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Belviq Xr's patents.

Given below is the list of recent legal activities going on the following patents of Belviq Xr.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 13 May, 2024 US8273734 (Litigated)
Interim Patent Term Extension Granted 21 Mar, 2024 US6953787 (Litigated)
Maintenance Fee Reminder Mailed 12 Feb, 2024 US8207158 (Litigated)
Post Issue Communication - Certificate of Correction 04 Jan, 2024 US8168624
PTE Interim Patent Extension filed 21 Dec, 2023 US6953787 (Litigated)
Requirement for information sent under 37 CFR 1.750 21 Dec, 2023 US6953787 (Litigated)
Withdrawal of Application for PTE 07 Dec, 2023 US8207158 (Litigated)
Withdrawal of Application for PTE 07 Dec, 2023 US7977329 (Litigated)
Withdrawal of Application for PTE 07 Dec, 2023 US7514422 (Litigated)
Withdrawal of Application for PTE 07 Dec, 2023 US8273734 (Litigated)


FDA has granted several exclusivities to Belviq Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Belviq Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Belviq Xr.

Exclusivity Information

Belviq Xr holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Belviq Xr's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 27, 2017

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US patents provide insights into the exclusivity only within the United States, but Belviq Xr is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Belviq Xr's family patents as well as insights into ongoing legal events on those patents.

Belviq Xr's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Belviq Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 07, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Belviq Xr Generics:

There are no approved generic versions for Belviq Xr as of now.

How can I launch a generic of Belviq Xr before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Belviq Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Belviq Xr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Belviq Xr -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
20 mg 13 Dec, 2016 1 07 Feb, 2033 Extinguished

Alternative Brands for Belviq Xr

Belviq Xr which is used for chronic weight management in adult patients., has several other brand drugs in the same treatment category and using the same active ingredient (Lorcaserin Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Eisai Inc
Belviq

(uses Lorcaserin Hydrochloride)

used for chronic weight management by treating obesity in patients who have achieved a 5% weight loss on a reduced-calorie diet.
Novo
Saxenda Used for managing type 2 diabetes, cardiovascular disease, and chronic weight management in obese individuals.





About Belviq Xr

Belviq Xr is a drug owned by Eisai Inc. It is used for chronic weight management in adult patients. Belviq Xr uses Lorcaserin Hydrochloride as an active ingredient. Belviq Xr was launched by Eisai Inc in 2016.

Approval Date:

Belviq Xr was approved by FDA for market use on 15 July, 2016.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Belviq Xr is 15 July, 2016, its NCE-1 date is estimated to be 27 June, 2016.

Active Ingredient:

Belviq Xr uses Lorcaserin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Lorcaserin Hydrochloride ingredient

Treatment:

Belviq Xr is used for chronic weight management in adult patients.

Dosage:

Belviq Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG TABLET, EXTENDED RELEASE Discontinued ORAL