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Last Updated: October 1, 2023

ELIDEL Drug Patent 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. Four suppliers are listed for this compound. Additional details are available on the pimecrolimus profile page.

DrugPatentWatch® 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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Summary for ELIDEL
Drug patent expirations by year for ELIDEL
Drug Prices for ELIDEL

See drug prices for ELIDEL

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

International Patents for ELIDEL

See the table below for patents covering ELIDEL around the world.

Country Patent Number Title Estimated Expiration
Colombia 4940463 MACROLIDAS CRISTALINAS ⤷  Try a Trial
Slovakia 284591 ⤷  Try a Trial
European Patent Office 0994880 MACROLIDES CRISTALLINS ET PROCEDE DE PREPARATION ASSOCIE (CRYSTALLINE MACROLIDES AND PROCESS FOR THEIR PREPARATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ELIDEL

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

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Serving leading biopharmaceutical companies globally:

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