BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Covington
Cerilliant
Healthtrust
Cipla
Medtronic
Express Scripts
Chinese Patent Office
Fuji
Dow

Generated: January 19, 2018

DrugPatentWatch Database Preview

Hydrocortisone butyrate - Generic Drug Details

« Back to Dashboard

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 Glenmark Generics, Taro Pharm Inds, Precision Dermat, Yamanouchi, and Taro, 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-four drug master file entries for hydrocortisone butyrate. Seven suppliers are listed for this compound.
Pharmacology for hydrocortisone butyrate

US Patents and Regulatory Information for hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yamanouchi LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019819-001 Sep 15, 1988 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Yamanouchi LOCOID hydrocortisone butyrate CREAM;TOPICAL 018795-001 Jan 7, 1983 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654-001 Aug 3, 2005 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Precision Dermat LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076-001 May 18, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Precision Dermat LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769-001 Sep 8, 1997 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro HYDROCORTISONE BUTYRATE hydrocortisone butyrate OINTMENT;TOPICAL 076842-001 Dec 27, 2004 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Precision Dermat LOCOID hydrocortisone butyrate SOLUTION;TOPICAL 019116-001 Feb 25, 1987 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Yamanouchi LOCOID hydrocortisone butyrate OINTMENT;TOPICAL 019106-001 Jul 3, 1984 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro Pharm Inds HYDROCORTISONE BUTYRATE hydrocortisone butyrate SOLUTION;TOPICAL 076364-001 Jan 14, 2004 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glenmark Generics HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145-001 Sep 27, 2013 AB2 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for 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
8,389,502 Stabilized steroid composition and method for its preparation ➤ Subscribe
8,546,364 Stabilized steroid composition and method for its preparation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Federal Trade Commission
Daiichi Sankyo
Novartis
Moodys
Chinese Patent Office
Merck
US Department of Justice

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.

botpot