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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
Formulation / Manufacturing:see details

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
Abraxis Pharm
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride
INJECTABLE;INJECTION080420-005Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Fresenius Kabi Usa
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
lidocaine hydrochloride
INJECTABLE;INJECTION080404-002Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
Watson Labs
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride
INJECTABLE;INJECTION080377-002Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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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, 20076,881,200<disabled>
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>
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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
5,630,796 Method of delivering powder transdermally with needless injector<disabled in preview>
7,942,846Needleless syringe using supersonic gas flow for particle delivery<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
Japan2006320737<disabled in preview>
New Zealand263606<disabled in preview>
Slovakia283855<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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