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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 215064


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NDA 215064 describes FILSUVEZ, which is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the FILSUVEZ profile page.

The generic ingredient in FILSUVEZ is birch triterpenes. Two suppliers are listed for this compound. Additional details are available on the birch triterpenes profile page.
Summary for 215064
Tradename:FILSUVEZ
Applicant:Chiesi
Ingredient:birch triterpenes
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215064
Generic Entry Date for 215064*:
Constraining patent/regulatory exclusivity:
TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
Dosage:
GEL;TOPICAL

*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: 215064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FILSUVEZ birch triterpenes GEL;TOPICAL 215064 NDA Chiesi USA, Inc. 10122-310 10122-310-02 1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)
FILSUVEZ birch triterpenes GEL;TOPICAL 215064 NDA Amryt Pharmaceuticals DAC 76431-310 76431-310-01 1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength10%
Approval Date:Dec 18, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 18, 2028
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 18, 2030
Regulatory Exclusivity Use:TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
Patent:⤷  Sign UpPatent Expiration:Jan 4, 2039Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.