By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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ZULRESSO Drug Profile
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When do Zulresso patents expire, and when can generic versions of Zulresso launch?
Zulresso is a drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this drug.
This drug has sixty-nine patent family members in twenty-five countries.
The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.
DrugPatentWatch® Generic Entry Outlook for Zulresso
Zulresso will be eligible for patent challenges on June 17, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ZULRESSO
| International Patents: | 69 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 2 |
| Patent Applications: | 629 |
| Drug Prices: | Drug price information for ZULRESSO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZULRESSO |
| What excipients (inactive ingredients) are in ZULRESSO? | ZULRESSO excipients list |
| DailyMed Link: | ZULRESSO at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZULRESSO
Generic Entry Date for ZULRESSO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ZULRESSO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sage Therapeutics | Phase 3 |
| Sage Therapeutics | Phase 4 |
US Patents and Regulatory Information for ZULRESSO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Sage Therap | ZULRESSO | brexanolone | SOLUTION;INTRAVENOUS | 211371-001 | Jun 17, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ZULRESSO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2015110671 | Try Before You Buy |
| Eurasian Patent Organization | 031355 | Try Before You Buy |
| Canada | 2892811 | Try Before You Buy |
| Israel | 208956 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
