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Lidocaine; tetracaine - Generic Drug Details

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Lidocaine; tetracaine is the generic ingredient in two branded drugs marketed by Galderma Labs Lp and Galen Specialty, and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-three patent family members in eleven countries.

There are twenty-nine drug master file entries for lidocaine; tetracaine. Three suppliers are listed for this compound.

Summary for Generic Name: lidocaine; tetracaine

Tradenames:2
Patents:8
Applicants:2
NDAs:2
Drug Master File Entries: see list29
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: lidocaine; tetracaine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 2005RXYes6,465,709► subscribeY ► subscribe
Galderma Labs Lp
PLIAGLIS
lidocaine; tetracaine
CREAM;TOPICAL021717-001Jun 29, 2006RXYes5,919,479► subscribeY ► subscribe
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 2005RXYes6,546,281► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: lidocaine; tetracaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
PLIAGLIS
lidocaine; tetracaine
CREAM;TOPICAL021717-001Jun 29, 20065,919,479► subscribe
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 20056,546,281► subscribe
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 20056,306,431► subscribe
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Non-Orange Book Patents for Generic Ingredient: lidocaine; tetracaine

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
6,955,819 Methods and apparatus for using controlled heat to regulate transdermal and controlled release delivery of fentanyl, other analgesics, and other medical substances► subscribe
6,340,472 Method for reducing onset time of pharmaceutically active compounds► subscribe
6,284,266 Methods and apparatus for improved administration of fentanyl and sufentanil► 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: lidocaine; tetracaine

Country Document Number Estimated Expiration
China1610540► subscribe
Denmark1244401► subscribe
European Patent Office1117356► 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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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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