Zulresso is a drug owned by Sage Therapeutics Inc. It is protected by 8 US drug patents filed from 2019 to 2021 out of which none have expired yet. Zulresso's patents have been open to challenges since 18 June, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 08, 2037. Details of Zulresso's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10940156 | Neuroactive steroids, compositions, and uses thereof |
Mar, 2037
(11 years from now) | Active |
| US10251894 | Anticonvulsant activity of steroids |
Nov, 2033
(8 years from now) | Active |
| US10322139 | Neuroactive steroid formulations and methods of treating CNS disorders |
Jan, 2033
(7 years from now) | Active |
| US9200088 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US9750822 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US7635773 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US10117951 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US8410077 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 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 Zulresso's patents.
Latest Legal Activities on Zulresso's Patents
Given below is the list of recent legal activities going on the following patents of Zulresso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2022 | US10322139 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Sep, 2022 | US10251894 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Mar, 2021 | US10940156 |
| Recordation of Patent Grant Mailed Critical | 09 Mar, 2021 | US10940156 |
| Email Notification Critical | 18 Feb, 2021 | US10940156 |
| Issue Notification Mailed Critical | 17 Feb, 2021 | US10940156 |
| Dispatch to FDC | 29 Jan, 2021 | US10940156 |
| Email Notification Critical | 18 Jan, 2021 | US10940156 |
| Mail Response to 312 Amendment (PTO-271) Critical | 18 Jan, 2021 | US10940156 |
| Response to Amendment under Rule 312 Critical | 13 Jan, 2021 | US10940156 |
FDA has granted several exclusivities to Zulresso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zulresso, 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 Zulresso.
Exclusivity Information
Zulresso holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Zulresso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 17, 2024 |
| New Patient Population(NPP) | Jun 16, 2025 |
Several oppositions have been filed on Zulresso's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zulresso's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zulresso patents.
Zulresso's Oppositions Filed in EPO
Zulresso has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 08, 2020, by Dr. Schön, Neymeyr & Partner Patentanwälte Mbb. This opposition was filed on patent number EP13740743A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13740743A | Jul, 2020 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Zulresso 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 Zulresso's family patents as well as insights into ongoing legal events on those patents.
Zulresso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zulresso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 08, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zulresso Generics:
There are no approved generic versions for Zulresso as of now.
Alternative Brands for Zulresso
Zulresso 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 | ||
|---|---|---|---|---|
| Biogen Inc |
| |||
About Zulresso
Zulresso is a drug owned by Sage Therapeutics Inc. It is used for treating postpartum depression. Zulresso uses Brexanolone as an active ingredient. Zulresso was launched by Sage Therap in 2019.
Can you believe Zulresso received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Zulresso was approved by FDA for market use on 17 June, 2019.
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 Zulresso is 17 June, 2019, its NCE-1 date is estimated to be 18 June, 2023.
Active Ingredient:
Zulresso uses Brexanolone as the active ingredient. Check out other Drugs and Companies using Brexanolone ingredient
Treatment:
Zulresso is used for treating postpartum depression.
Dosage:
Zulresso is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/20ML (5MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |