Details for New Drug Application (NDA): 212102
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NDA 212102 describes FINTEPLA, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the FINTEPLA profile page.
The generic ingredient in FINTEPLA is fenfluramine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fenfluramine hydrochloride profile page.
The generic ingredient in FINTEPLA is fenfluramine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fenfluramine hydrochloride profile page.
Summary for 212102
| Tradename: | FINTEPLA |
| Applicant: | Ucb Inc |
| Ingredient: | fenfluramine hydrochloride |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212102
Generic Entry Date for 212102*:
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.
Suppliers and Packaging for NDA: 212102
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102 | NDA | UCB, Inc. | 43376-322 | 43376-322-30 | 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC |
| FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102 | NDA | UCB, Inc. | 43376-322 | 43376-322-36 | 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 2.2MG BASE/ML | ||||
| Approval Date: | Jun 25, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 25, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Mar 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Dec 25, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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