Belsomra is a drug owned by Merck Sharp And Dohme Corp. It is protected by 3 US drug patents filed from 2014 to 2024 out of which none have expired yet. Belsomra's patents have been open to challenges since 13 August, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be May 29, 2033. Details of Belsomra'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. | |||
| US7951797 | Substituted diazepan orexin receptor antagonists |
Nov, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10098892 | Solid dosage formulations of an orexin receptor antagonist |
May, 2033
(8 years from now) | Active |
| US11980623 | Solid dosage formulations of an orexin receptor antagonist |
May, 2033
(8 years from now) | Active |
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 Belsomra's patents.
Latest Legal Activities on Belsomra's Patents
Given below is the list of recent legal activities going on the following patents of Belsomra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2022 | US7951797 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Mar, 2022 | US10098892 |
| Notice of Final Determination -Eligible | 26 Feb, 2021 | US7951797 |
| FDA Final Eligibility Letter Critical | 03 Jul, 2019 | US7951797 |
| Recordation of Patent Grant Mailed Critical | 16 Oct, 2018 | US10098892 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Oct, 2018 | US7951797 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Oct, 2018 | US10098892 |
| Email Notification Critical | 27 Sep, 2018 | US10098892 |
| Issue Notification Mailed Critical | 26 Sep, 2018 | US10098892 |
| Dispatch to FDC | 17 Sep, 2018 | US10098892 |
FDA has granted several exclusivities to Belsomra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Belsomra, 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 Belsomra.
Exclusivity Information
Belsomra holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Belsomra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 13, 2019 |
| M(M-253) | Jan 29, 2023 |
US patents provide insights into the exclusivity only within the United States, but Belsomra 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 Belsomra's family patents as well as insights into ongoing legal events on those patents.
Belsomra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Belsomra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 29, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Belsomra Generics:
There are no approved generic versions for Belsomra as of now.
Alternative Brands for Belsomra
Belsomra which is used for promoting sleep and treating insomnia., has several other brand drugs in the same treatment category . 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.
About Belsomra
Belsomra is a drug owned by Merck Sharp And Dohme Corp. It is used for promoting sleep and treating insomnia. Belsomra uses Suvorexant as an active ingredient. Belsomra was launched by Merck Sharp Dohme in 2014.
Approval Date:
Belsomra was approved by FDA for market use on 13 August, 2014.
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 Belsomra is 13 August, 2014, its NCE-1 date is estimated to be 13 August, 2018.
Active Ingredient:
Belsomra uses Suvorexant as the active ingredient. Check out other Drugs and Companies using Suvorexant ingredient
Treatment:
Belsomra is used for promoting sleep and treating insomnia.
Dosage:
Belsomra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |