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Last Updated: July 16, 2020

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ELIDEL Drug Profile

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When do Elidel patents expire, and when can generic versions of Elidel launch?

Elidel is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Elidel

A generic version of ELIDEL was approved as pimecrolimus by ACTAVIS LABS UT INC on December 27th, 2018.

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Drug patent expirations by year for ELIDEL
Drug Prices for ELIDEL

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Recent Clinical Trials for ELIDEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St Joseph University, Beirut, LebanonPhase 2/Phase 3
PfizerPhase 4
Glenmark Pharmaceuticals Ltd. IndiaPhase 3

See all ELIDEL clinical trials

Pharmacology for ELIDEL

US Patents and Regulatory Information for ELIDEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ELIDEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001   Start Trial   Start Trial
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001   Start Trial   Start Trial
Bausch ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ELIDEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0427680 SPC/GB03/015 United Kingdom   Start Trial PRODUCT NAME: PIMECROLIMUS OR SALTS OR ESTERS THEREOF; REGISTERED: DK 21034 (MT-NO.32700) 20020315; UK PL 00101/0659 20021003
0427680 12/2003 Austria   Start Trial PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE; NAT. REGISTRATION NO/DATE: 1-24689 20020917; FIRST REGISTRATION: DK 21034 20020315
0427680 91021 Luxembourg   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
Merck
Medtronic
Mallinckrodt
Express Scripts

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