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Lidocaine hydrochloride - Generic Drug Details

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Lidocaine hydrochloride is the generic ingredient in thirty-five branded drugs marketed by Intl Medication, Fresenius Kabi Usa, Hospira, Roxane, Graham Chem, Eurohlth Intl Sarl, Abraxis Pharm, Vintage, Bel Mar, Miles, Hi Tech Pharma, Powder Pharms, Oak Pharms, Astrazeneca, G And W Labs Inc, Akorn, Carlisle, Elkins Sinn, Watson Labs, Pharmaton, Bionpharma Inc, B Braun, Kendall Il, Gd Searle Llc, Watson Labs Inc, Aurobindo Pharma Ltd, Mylan Labs Ltd, Meridian Medcl Techn, Luitpold, Abbott, Baxter Hlthcare, Luitpold Pharms Inc, Wockhardt, Actavis Mid Atlantic, Dentsply Pharm, Wyeth Ayerst, Dell Labs, Paco, Lyphomed, Sagent Pharms, Teligent Pharma Inc, and Pfizer, and is included in ninety-eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-four patent family members in thirty-four countries.

There are twenty-nine drug master file entries for lidocaine hydrochloride. Forty-nine suppliers are listed for this compound.

Summary for Generic Name: lidocaine hydrochloride

Tradenames:35
Patents:7
Applicants:42
NDAs:98
Drug Master File Entries: see list29
Suppliers / Packaging: see list49
Therapeutic Class:Anesthetics
Drug Prices:see low prices

Clinical Trials for: lidocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride
INJECTABLE;INJECTION083158-001Approved Prior to Jan 1, 1982RXNo
Astrazeneca
XYLOCAINE
lidocaine hydrochloride
INJECTABLE;INJECTION010418-007Approved Prior to Jan 1, 1982DISCNNo
Powder Pharms
ZINGO
lidocaine hydrochloride
SYSTEM;INTRADERMAL022114-001Aug 16, 2007RXNo9,370,622Sep 28, 2035
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Expired Orange Book Patents for Generic Ingredient: lidocaine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Powder Pharms
ZINGO
lidocaine hydrochloride
SYSTEM;INTRADERMAL022114-001Aug 16, 20075,630,796<disabled>
Powder Pharms
ZINGO
lidocaine hydrochloride
SYSTEM;INTRADERMAL022114-001Aug 16, 20075,899,880<disabled>
Powder Pharms
ZINGO
lidocaine hydrochloride
SYSTEM;INTRADERMAL022114-001Aug 16, 20076,881,200<disabled>
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Non-Orange Book Patents for Generic Ingredient: lidocaine hydrochloride

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
7,942,846Needleless syringe using supersonic gas flow for particle delivery<disabled in preview>
5,630,796 Method of delivering powder transdermally with needless injector<disabled in preview>
6,168,587 Needleless syringe using supersonic gas flow for particle delivery<disabled in preview>
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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 hydrochloride

Country Document Number Estimated Expiration
HungaryT73516<disabled in preview>
United Kingdom9318407<disabled in preview>
Poland311005<disabled in preview>
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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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