Zurzuvae Patent Expiration

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.

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

Activity Date Patent Number
Patent litigations
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 30 Jan, 2024 US11884696
Recordation of Patent eGrant 30 Jan, 2024 US11884696
Mail Patent eGrant Notification 30 Jan, 2024 US11884696
Email Notification 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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


Family Patents

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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
Zulresso Used for treating postpartum depression.





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