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EPIDIOLEX Drug Profile
» See Plans and Pricing
When do Epidiolex patents expire, and what generic alternatives are available?
Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. There are ten patents protecting this drug.
This drug has fifty-nine patent family members in fifteen countries.
The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cannabidiol profile page.
US ANDA Litigation and Generic Entry Outlook for Epidiolex
Epidiolex will be eligible for patent challenges on September 28, 2022. 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 September 28, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for EPIDIOLEX
| International Patents: | 59 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 22 |
| Patent Applications: | 2,265 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPIDIOLEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPIDIOLEX |
| DailyMed Link: | EPIDIOLEX at DailyMed |
Generic Entry Opportunity Date for EPIDIOLEX
Generic Entry Date for EPIDIOLEX*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER NDA:
Dosage:
SOLUTION;ORAL |
*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 EPIDIOLEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zin W Myint | Phase 1 |
| Mayo Clinic | Phase 2/Phase 3 |
| National Center for Complementary and Integrative Health (NCCIH) | Early Phase 1 |
US Patents and Regulatory Information for EPIDIOLEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gw Res Ltd | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 EPIDIOLEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015275887 | Start Trial |
| Japan | 2020059723 | Start Trial |
| United Kingdom | 0111046 | Start Trial |
| Poland | 3157511 | Start Trial |
| Australia | 2002255150 | Start Trial |
| United Kingdom | 2530001 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
