.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

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

DrugPatentWatch Database Preview

Hydrocortisone butyrate - Generic Drug Details

« Back to Dashboard
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 one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifty-three drug master file entries for hydrocortisone butyrate. Eight suppliers are listed for this compound.

Summary for Generic Name: hydrocortisone butyrate

Tradenames:3
Patents:2
Applicants:5
NDAs:12
Drug Master File Entries: see list53
Suppliers / Packaging: see list8
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydrocortisone butyrate

Clinical Trials for: hydrocortisone butyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yamanouchi
LOCOID
hydrocortisone butyrate
SOLUTION;TOPICAL019819-001Sep 15, 1988DISCNNo<disabled><disabled>
Precision Dermat
LOCOID
hydrocortisone butyrate
LOTION;TOPICAL022076-001May 18, 2007RXYes7,981,877<disabled>Y <disabled>
Taro Pharm Inds
HYDROCORTISONE BUTYRATE
hydrocortisone butyrate
SOLUTION;TOPICAL076364-001Jan 14, 2004RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: hydrocortisone butyrate

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Precision Dermat
LOCOID LIPOCREAM
hydrocortisone butyrate
CREAM;TOPICAL020769-001Sep 8, 19975,635,497<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,546,364Stabilized steroid composition and method for its preparation<disabled in preview>
8,389,502Stabilized steroid composition and method for its preparation<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

How are People Using DrugPatentWatch?

`abc