Quviviq is a drug owned by Idorsia Pharmaceuticals Ltd. It is protected by 3 US drug patents filed in 2022 out of which none have expired yet. Quviviq's patents will be open to challenges from 07 April, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 02, 2034. Details of Quviviq'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. | |||
| US9790208 | Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist |
Dec, 2034
(9 years from now) | Active |
| US9732075 | Benzimidazole-proline derivatives |
Jun, 2033
(8 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). | |||
| US10023560 | Crystalline salt form of (S)-(2-(6 chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist |
Dec, 2034
(9 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 Quviviq's patents.
Latest Legal Activities on Quviviq's Patents
Given below is the list of recent legal activities going on the following patents of Quviviq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Pub Notice re 312 amendment | 31 May, 2024 | US9732075 |
| Email Notification Critical | 31 May, 2024 | US9732075 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 28 May, 2024 | US9732075 |
| Second letter to regulating agency to determine regulatory review period | 23 Oct, 2023 | US9732075 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US9732075 |
| Initial letter Re: PTE Application to regulating agency | 28 Dec, 2022 | US9732075 |
| Post Issue Communication - Certificate of Correction | 18 Nov, 2022 | US9732075 |
| Post Issue Communication - Certificate of Correction | 01 Aug, 2022 | US9732075 |
| Post Issue Communication - Certificate of Correction | 20 May, 2022 | US9732075 |
| Email Notification Critical | 29 Apr, 2022 | US9732075 |
FDA has granted several exclusivities to Quviviq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Quviviq, 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 Quviviq.
Exclusivity Information
Quviviq holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Quviviq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 07, 2027 |
| M(M-310) | Sep 30, 2027 |
US patents provide insights into the exclusivity only within the United States, but Quviviq 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 Quviviq's family patents as well as insights into ongoing legal events on those patents.
Quviviq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Quviviq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Quviviq Generics:
There are no approved generic versions for Quviviq as of now.
Alternative Brands for Quviviq
Quviviq which is used for 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 Quviviq
Quviviq is a drug owned by Idorsia Pharmaceuticals Ltd. It is used for treating insomnia. Quviviq uses Daridorexant Hydrochloride as an active ingredient. Quviviq was launched by Idorsia in 2022.
Approval Date:
Quviviq was approved by FDA for market use on 07 April, 2022.
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 Quviviq is 07 April, 2022, its NCE-1 date is estimated to be 07 April, 2026.
Active Ingredient:
Quviviq uses Daridorexant Hydrochloride as the active ingredient. Check out other Drugs and Companies using Daridorexant Hydrochloride ingredient
Treatment:
Quviviq is used for treating insomnia.
Dosage:
Quviviq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |