Details for New Drug Application (NDA): 210365
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NDA 210365 describes EPIDIOLEX, which is a drug marketed by Jazz Pharms Res and is included in one NDA. It is available from one supplier. There are twenty-nine patents protecting this drug. Additional details are available on the EPIDIOLEX profile page.
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.
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.
Summary for 210365
| Tradename: | EPIDIOLEX |
| Applicant: | Jazz Pharms Res |
| Ingredient: | cannabidiol |
| Patents: | 29 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210365
Generic Entry Date for 210365*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 210365
Suppliers and Packaging for NDA: 210365
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365 | NDA | Jazz Pharmaceuticals, Inc. | 70127-100 | 70127-100-10 | 1 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01) |
| EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365 | NDA | Jazz Pharmaceuticals, Inc. | 70127-100 | 70127-100-60 | 1 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
| Approval Date: | Sep 28, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 28, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Oct 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
| Regulatory Exclusivity Expiration: | Jul 31, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE | ||||||||
Expired US Patents for NDA 210365
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Jazz Pharms Res | EPIDIOLEX | cannabidiol | SOLUTION;ORAL | 210365-001 | Sep 28, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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