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Desonide - Generic Drug Details

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Desonide is the generic ingredient in four branded drugs marketed by Perrigo New York, Galderma Labs Lp, G And W Labs Inc, Bayer Hlthcare, Taro, Fougera Pharms, and Aqua Pharms, and is included in thirteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-two patent family members in twenty-five countries.

There are twenty-eight drug master file entries for desonide. Fourteen suppliers are listed for this compound.

Summary for Generic Name: desonide

Tradenames:4
Patents:5
Applicants:7
NDAs:13
Drug Master File Entries: see list28
Suppliers / Packaging: see list14
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: desonide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc
DESONIDE
desonide
CREAM;TOPICAL074027-001Sep 28, 1992RXNo► subscribe► subscribe
Perrigo New York
DESONIDE
desonide
OINTMENT;TOPICAL017426-001Approved Prior to Jan 1, 1982RXYes► subscribe► subscribe
Fougera Pharms
DESONIDE
desonide
LOTION;TOPICAL075860-001Mar 19, 2002RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: desonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,629,128Vitamin formulation► subscribe
6,517,847 Topical gel delivery system► subscribe
8,263,580Vitamin formulation► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: desonide

Country Document Number Estimated Expiration
European Patent Office2052714► subscribe
Russian Federation2007111706► subscribe
Portugal2052714► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DESONIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90049-3Sweden► subscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
2013025Lithuania► subscribePRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
2013 00053Denmark► subscribePRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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