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Last Updated: January 30, 2023

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, Cadila, Cosette, Glenmark Pharms, Padagis Us, Taro, Galderma Labs Lp, Leo Pharma As, Cintex Svcs, Aleor Dermaceuticals, Fougera Pharms, Pai Holdings Pharm, Akorn, Encube Ethicals, and Glenmark Pharms Ltd, and is included in twenty-four 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. Twenty 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

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

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
Akorn DESONIDE desonide OINTMENT;TOPICAL 208836-001 Mar 27, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DESOWEN desonide OINTMENT;TOPICAL 071425-001 Jun 15, 1988 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fougera Pharms DESONIDE desonide LOTION;TOPICAL 075860-001 Mar 19, 2002 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pai Holdings Pharm DESONIDE desonide LOTION;TOPICAL 207855-001 Sep 28, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro DESONIDE desonide LOTION;TOPICAL 202161-001 Oct 31, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 See Plans and Pricing See Plans and Pricing
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for desonide

Country Patent Number Title Estimated Expiration
Hong Kong 1110198 MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS See Plans and Pricing
Russian Federation 2381023 СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION) See Plans and Pricing
South Africa 200702702 Microemulsion & sub-micron emulsion process & compositions See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006024095 See Plans and Pricing
European Patent Office 2438910 Procédé et compositions de micro-émulsion et d'émulsion submicronique (Microemulsion & sub-micron emulsion process & compositions) See Plans and Pricing
Spain 2429040 See Plans and Pricing
Argentina 051197 UN PROCEDIMIENTO PARA OBTENER UNA MICROEMULSION Y SUB-MICRON EMULSION Y COMPOSICIONES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for desonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 301102 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0613371 SPC/GB02/033 United Kingdom See Plans and Pricing 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 2190014-7 Sweden See Plans and Pricing PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024 2021C/518 Belgium See Plans and Pricing 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
2435024 132021000000095 Italy See Plans and Pricing PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024 21C1020 France See Plans and Pricing 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 LUC00208 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Boehringer Ingelheim

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