DESONIDE - Generic Drug Details

What are the generic drug 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.

Summary for DESONIDE

International Patents:	22
US Patents:	3
Tradenames:	4
Applicants:	15
NDAs:	25
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	8
Patent Applications:	6,966
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for DESONIDE
Drug Sales Revenues:	Drug sales revenues for DESONIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESONIDE
What excipients (inactive ingredients) are in DESONIDE?	DESONIDE excipients list
DailyMed Link:	DESONIDE at DailyMed

See drug prices for DESONIDE

See drug sales revenues for DESONIDE

Recent Clinical Trials for DESONIDE

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

Sponsor	Phase
Procter and Gamble	Phase 3
EMS	Phase 4
Massachusetts General Hospital	Phase 3

See all DESONIDE clinical trials

Pharmacology for DESONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for DESONIDE

Anti-Inflammatory Agents

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
Cintex Svcs	DESONIDE	desonide	GEL;TOPICAL	202470-001	May 11, 2020		RX	No	Yes
Glenmark Pharms Ltd	DESONIDE	desonide	OINTMENT;TOPICAL	209996-001	Sep 15, 2017	AB	RX	No	No
Glenmark Pharms	DESONIDE	desonide	CREAM;TOPICAL	209729-001	Jul 24, 2017	AB	RX	No	No
Alembic	DESONIDE	desonide	OINTMENT;TOPICAL	212473-001	Oct 23, 2019	AB	RX	No	No
Padagis Us	DESONIDE	desonide	OINTMENT;TOPICAL	017426-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

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
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006

International Patents for DESONIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	101243526
Canada	2756674	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)
Israel	181632	תכשירים ותהליך להכנת מיקרואמולסיה ואמולסיה תת-מיקרונים (Microemulsion and sub-micron emulsion process and compositions)
Poland	1796636
China	101048136	Microemulsion and sub-micron emulsion process and compositions

Supplementary Protection Certificates for DESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2190014-7	Sweden		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
0613371	SPC/GB02/033	United Kingdom		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		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	301102	Netherlands		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
2435024	2021C/518	Belgium		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