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Last Updated: March 29, 2024

Desonide - Generic Drug Details


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What are the generic sources for desonide and what is the scope of freedom to operate?

Desonide is the generic ingredient in four branded drugs marketed by Almirall, Alembic, Cadila, Cosette, Glenmark Pharms, Padagis Us, Taro, Galderma Labs Lp, Leo Pharma As, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Desonide has twenty-two patent family members in sixteen countries.

There are thirty-one drug master file entries for desonide. Eighteen suppliers are listed for this compound.

Drug Prices for desonide

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Drug Sales Revenue Trends for desonide

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Recent Clinical Trials for desonide

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SponsorPhase
Procter and GamblePhase 3
EMSPhase 4
NeoStrata Company, Inc.Phase 3

See all desonide clinical trials

Pharmacology for desonide
Medical Subject Heading (MeSH) Categories for desonide
Paragraph IV (Patent) Challenges for DESONIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DESONATE Gel desonide 0.05% 021844 1 2010-12-01

US Patents and Regulatory Information for desonide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms DESONIDE desonide LOTION;TOPICAL 075860-001 Mar 19, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic DESONIDE desonide OINTMENT;TOPICAL 212473-001 Oct 23, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DESOWEN desonide OINTMENT;TOPICAL 071425-001 Jun 15, 1988 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 DISCN Yes No ⤷  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 desonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for desonide

Country Patent Number Title Estimated Expiration
Israel 181632 תכשירים ותהליך להכנת מיקרואמולסיה ואמולסיה תת-מיקרונים (Microemulsion and sub-micron emulsion process and compositions) ⤷  Try a Trial
Russian Federation 2381023 СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION) ⤷  Try a Trial
European Patent Office 1796636 PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS) ⤷  Try a Trial
China 101048136 Microemulsion and sub-micron emulsion process and compositions ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for desonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom ⤷  Try a Trial PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024 SPC/GB21/029 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 2021C/518 Belgium ⤷  Try a Trial PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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