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Lidocaine; tetracaine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for lidocaine; tetracaine?

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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine; tetracaine has twenty 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:2
Applicants:2
NDAs:2
Drug Master File Entries: see list29
Suppliers / Packagers: see list3
Clinical Trials: see list376
Drug Prices:see low prices
DailyMed Link:lidocaine; tetracaine at DailyMed

Pharmacology for Ingredient: lidocaine; tetracaine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 2005RXYesYes6,465,709► SubscribeY ► Subscribe
Galderma Labs Lp
PLIAGLIS
lidocaine; tetracaine
CREAM;TOPICAL021717-001Jun 29, 2006RXYesYes6,528,086► 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, 20055,658,583► Subscribe
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 20056,465,006► Subscribe
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 20056,306,431► Subscribe
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International Patent Family for Ingredient: lidocaine; tetracaine

Country Document Number Estimated Expiration
Japan2012246315► Subscribe
World Intellectual Property Organization (WIPO)0122907► Subscribe
Austria345757► Subscribe
Australia7719800► Subscribe
Canada2386017► 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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