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, 1 month from now) | Active |
| US8367657 | Processes for preparing 3-benzazepines |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US6953787 | 5HT2C receptor modulators |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US8546379 | 5HT2C receptor modulators |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US7977329 | 5HT2C receptor modulators |
Apr, 2023
(1 year, 7 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
(8 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, 1 month from now) | Active |
| US8946207 | Processes for preparing 3-benzazepines |
Jun, 2024
(4 months ago) |
Expired
|
| US8273734 | 5HT2C receptor modulators |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US7514422 | 5HT2c receptor modulators |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US8575149 | 5HT2C receptor modulators |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US8207158 | 5HT2c receptor modulators |
Apr, 2023
(1 year, 7 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.
Latest 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 |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 13 May, 2024 | US8273734 (Litigated) |
| Interim Patent Term Extension Granted Critical | 21 Mar, 2024 | US6953787 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 12 Feb, 2024 | US8207158 (Litigated) |
| Post Issue Communication - Certificate of Correction | 04 Jan, 2024 | US8168624 |
| PTE Interim Patent Extension filed Critical | 21 Dec, 2023 | US6953787 (Litigated) |
| Requirement for information sent under 37 CFR 1.750 | 21 Dec, 2023 | US6953787 (Litigated) |
| Withdrawal of Application for PTE Critical | 07 Dec, 2023 | US8207158 (Litigated) |
| Withdrawal of Application for PTE Critical | 07 Dec, 2023 | US7977329 (Litigated) |
| Withdrawal of Application for PTE Critical | 07 Dec, 2023 | US7514422 (Litigated) |
| Withdrawal of Application for PTE Critical | 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 |
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
Explore Our Curated Drug Screens
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 |
| |||
| Novo |
| |||
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 |