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Last Updated: April 12, 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. Seventeen 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
Galderma Labs Lp DESOWEN desonide LOTION;TOPICAL 072354-001 Jan 24, 1992 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us DESONIDE desonide CREAM;TOPICAL 017010-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro DESONIDE desonide CREAM;TOPICAL 073548-001 Jun 30, 1992 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro DESONIDE desonide LOTION;TOPICAL 202161-001 Oct 31, 2014 AB RX No 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
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
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
>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 ⤷  Try a Trial
China 101048136 Microemulsion and sub-micron emulsion process and compositions ⤷  Try a Trial
Spain 2429040 ⤷  Try a Trial
Canada 2578594 PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & 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
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 132021000000095 Italy ⤷  Try a Trial 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 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
2435024 LUC00208 Luxembourg ⤷  Try a Trial 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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