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Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Daiichi Sankyo
Colorcon
Harvard Business School
Baxter
Farmers Insurance
Teva
Novartis
UBS

Generated: October 24, 2017

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Hydrocortisone butyrate - Generic Drug Details

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What are the generic sources for hydrocortisone butyrate and what is the scope of hydrocortisone butyrate patent protection?

Hydrocortisone butyrate
is the generic ingredient in three branded drugs marketed by Yamanouchi, Precision Dermat, Taro, Glenmark Generics, and Taro Pharm Inds, and is included in twelve NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixty drug master file entries for hydrocortisone butyrate. Eight suppliers are listed for this compound.

Summary for Generic Name: hydrocortisone butyrate

US Patents:2
Tradenames:3
Applicants:5
NDAs:12
Drug Master File Entries: see list60
Suppliers / Packagers: see list8
Bulk Api Vendors: see list49
Clinical Trials: see list313
Patent Applications: see list4,052
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydrocortisone butyrate at DailyMed

Pharmacology for Ingredient: hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro Pharm Inds
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
CREAM;TOPICAL076654-001Aug 3, 2005AB1RXNoNo► Subscribe► Subscribe► Subscribe
Taro Pharm Inds
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
SOLUTION;TOPICAL076364-001Jan 14, 2004ATRXNoNo► Subscribe► Subscribe► Subscribe
Yamanouchi
LOCOID
hydrocortisone butyrate
OINTMENT;TOPICAL019106-001Jul 3, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Precision Dermat
LOCOID
hydrocortisone butyrate
LOTION;TOPICAL022076-001May 18, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Yamanouchi
LOCOID
hydrocortisone butyrate
SOLUTION;TOPICAL019819-001Sep 15, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Precision Dermat
LOCOID LIPOCREAM
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 1997AB2RXYesYes► Subscribe► Subscribe► Subscribe
Precision Dermat
LOCOID
hydrocortisone butyrate
OINTMENT;TOPICAL018652-001Oct 29, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Yamanouchi
LOCOID
hydrocortisone butyrate
CREAM;TOPICAL018795-001Jan 7, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Precision Dermat
LOCOID
hydrocortisone butyrate
LOTION;TOPICAL022076-001May 18, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Precision Dermat
LOCOID
hydrocortisone butyrate
SOLUTION;TOPICAL019116-001Feb 25, 1987ATRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Precision Dermat
LOCOID LIPOCREAM
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: hydrocortisone butyrate

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
8,389,502Stabilized steroid composition and method for its preparation► Subscribe
8,546,364Stabilized steroid composition and method for its preparation► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Queensland Health
Healthtrust
Argus Health
Farmers Insurance
Express Scripts
Covington
Julphar
Moodys
US Army

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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