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 six patents protecting this drug. Additional details are available on the FILSUVEZ profile page.
The generic ingredient in FILSUVEZ is birch triterpenes. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the birch triterpenes profile page.
The generic ingredient in FILSUVEZ is birch triterpenes. There is one drug master file entry for this compound. 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: | 6 |
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: | ⤷ Start Trial | Patent Expiration: | Jan 4, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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