Details for New Drug Application (NDA): 215064
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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: | RX | Dosage: | GEL;TOPICAL | Strength | 10% | ||||
Approval Date: | Dec 18, 2023 | TE: | 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 Up | Patent Expiration: | Jan 4, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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