Zurzuvae is a drug owned by Biogen Inc. It is protected by 5 US drug patents filed from 2023 to 2024 out of which none have expired yet. Zurzuvae's patents will be open to challenges from 01 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 24, 2037. Details of Zurzuvae'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. | |||
| US11236121 | Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid |
Aug, 2037
(12 years from now) | Active |
| US9512165 | 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof |
Apr, 2034
(9 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). | |||
| US11884696 | Crystalline 19-nor C3,3-disubstituted C21-n-pyrazolyl steroid |
Dec, 2037
(13 years from now) | Active |
| US10172871 | 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof |
Apr, 2034
(9 years from now) | Active |
| US10342810 | 19-nor C3, 3-disubstituted C21-N-pyrazolyl steroids and methods of use thereof |
Apr, 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 Zurzuvae's patents.
Latest Legal Activities on Zurzuvae's Patents
Given below is the list of recent legal activities going on the following patents of Zurzuvae.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9512165 |
| Initial letter Re: PTE Application to regulating agency | 05 Mar, 2024 | US11236121 |
| Initial letter Re: PTE Application to regulating agency | 05 Mar, 2024 | US10172871 |
| Initial letter Re: PTE Application to regulating agency | 05 Mar, 2024 | US10342810 |
| Initial letter Re: PTE Application to regulating agency | 05 Mar, 2024 | US9512165 |
| Patent eGrant Notification | 30 Jan, 2024 | US11884696 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Jan, 2024 | US11884696 |
| Recordation of Patent eGrant | 30 Jan, 2024 | US11884696 |
| Mail Patent eGrant Notification | 30 Jan, 2024 | US11884696 |
| Email Notification Critical | 30 Jan, 2024 | US11884696 |
FDA has granted several exclusivities to Zurzuvae. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zurzuvae, 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 Zurzuvae.
Exclusivity Information
Zurzuvae holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Zurzuvae's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 31, 2028 |
US patents provide insights into the exclusivity only within the United States, but Zurzuvae 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 Zurzuvae's family patents as well as insights into ongoing legal events on those patents.
Zurzuvae's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zurzuvae's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 24, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zurzuvae Generics:
There are no approved generic versions for Zurzuvae as of now.
Alternative Brands for Zurzuvae
Zurzuvae which is used for treating postpartum depression., 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Sage Therap |
| |||
About Zurzuvae
Zurzuvae is a drug owned by Biogen Inc. It is used for treating postpartum depression. Zurzuvae uses Zuranolone as an active ingredient. Zurzuvae was launched by Biogen Inc in 2023.
Approval Date:
Zurzuvae was approved by FDA for market use on 31 October, 2023.
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 Zurzuvae is 31 October, 2023, its NCE-1 date is estimated to be 01 November, 2027.
Active Ingredient:
Zurzuvae uses Zuranolone as the active ingredient. Check out other Drugs and Companies using Zuranolone ingredient
Treatment:
Zurzuvae is used for treating postpartum depression.
Dosage:
Zurzuvae is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG | CAPSULE | Prescription | ORAL |
| 25MG | CAPSULE | Prescription | ORAL |
| 20MG | CAPSULE | Prescription | ORAL |