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Generated: September 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021302

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NDA 021302 describes ELIDEL, which is a drug marketed by Valeant Bermuda and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ELIDEL profile page.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimecrolimus profile page.
Summary for 021302
Tradename:ELIDEL
Applicant:Valeant Bermuda
Ingredient:pimecrolimus
Patents:1
Generic Entry Opportunity Date for 021302
Generic Entry Date for 021302*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;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.

Pharmacology for NDA: 021302
Mechanism of ActionCalcineurin Inhibitors
Suppliers and Packaging for NDA: 021302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIDEL pimecrolimus CREAM;TOPICAL 021302 NDA Valeant Pharmaceuticals North America LLC 0187-5100 0187-5100-01 1 TUBE in 1 CARTON (0187-5100-01) > 30 g in 1 TUBE
ELIDEL pimecrolimus CREAM;TOPICAL 021302 NDA Valeant Pharmaceuticals North America LLC 0187-5101 0187-5101-02 1 TUBE in 1 CARTON (0187-5101-02) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 13, 2001TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 26, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021302

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Bermuda ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 ➤ Sign Up ➤ Sign Up
Valeant Bermuda ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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