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LOCOID Drug Profile

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Locoid is a drug marketed by Yamanouchi and Precision Dermat and is included in eight NDAs. It is available from five suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in LOCOID is hydrocortisone butyrate. There are fifty-seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

Summary for Tradename: LOCOID

Suppliers / Packagers: see list5
Clinical Trials: see list3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LOCOID at DailyMed

Pharmacology for Tradename: LOCOID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
hydrocortisone butyrate
OINTMENT;TOPICAL019106-001Jul 3, 1984DISCNNoNo► subscribe► subscribe
Precision Dermat
hydrocortisone butyrate
LOTION;TOPICAL022076-001May 18, 2007RXYesYes7,981,877► subscribeY ► subscribe
hydrocortisone butyrate
SOLUTION;TOPICAL019819-001Sep 15, 1988DISCNNoNo► subscribe► subscribe
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Paragraph IV activity for: LOCOID

Drugname Dosage Strength RLD Submissiondate
hydrocortisone butyrateLotion0.1%Locoid 8/31/2016
hydrocortisone butyrateCream0.1%Locoid Lipocream6/28/2010

Premature patent expiration for: LOCOID

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
May 27, 2016

Non-Orange Book Patents for Tradename: LOCOID

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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