Lidocaine Hydrochloride

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

48 Suppliers, 13 USDMF, 8 CEP/COS, 3 JDMF, 9 EU WC, 12 KDMF, 29 NDC API, 35 Listed Suppliers

DEVELOPMENTS

4 Drug(s) in Development

4 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

DOSSIERs // Finished Dosage Forms

382 Dossiers, 225 FDA Orange Book, 48 Europe, 63 Canada, 15 South Africa, 31 Listed Dossiers

DRUG PRODUCT COMPOSITION

INJECTABLE;INJECTION - 4%, INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 0.005MG/ML;0.5%, INJECTABLE;INJECTION - 0.005MG/ML;1%, INJECTABLE;INJECTION - 0.005MG/ML;1.5%, INJECTABLE;INJECTION - 0.005MG/ML;2%, INJECTABLE;INJECTION - 0.01MG/ML;1%, INJECTABLE;INJECTION - 0.01MG/ML;2%, INJECTABLE;INJECTION - 0.02MG/ML;2%, INJECTABLE;INJECTION - 0.5%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 1.5%, INJECTABLE;INJECTION - 2%, INJECTABLE;INJECTION - 1%, INJECTABLE;INJECTION - 2%, INJECTABLE;SPINAL - 5%, JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%, INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

RELATED EXCIPIENT COMPANIES

Suppliers, 43 BASF, 25 Seppic, 22 Actylis, 21 Roquette, 18 Kerry, 17 Nanjing Well Pharmaceutical, 17 Corel Pharma Chem, 13 Gangwal Chemicals, 12 SPI Pharma, 9 Microlex e.U, 9 Lubrizol Life Science Health, 6 Lonza Capsugel, 6 DKSH, 6 Rochem International Inc, 5 Finar, 4 Kima Chemical, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Sigachi Industries, 4 Ideal Cures Pvt Ltd, 3 Aeon Procare, 3 Shandong Focus Biotechnology Co., Ltd, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Nanjing Bold Chemical, 3 Gangwal Healthcare, 3 Seqens, 3 The Dow Chemical Company, 3 Doshion Polyscience, 2 Nippon Fine Chemical, 2 Ingredion Pharma Solutions, 2 Nomisma Healthcare, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Pharmatrans-Sanaq, 1 Clariant, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Pharm-RX Chemical, 1 ACG Worldwide, 1 Qualicaps, 1 Bioplus Life Sciences, 1 PMC Isochem, 1 BioSpectra, 1 Pfanstiehl, 1 Ulanqab Kema New Material, 1 Boai NKY Pharmaceuticals Ltd, 1 Zhejiang Huakang Pharmaceutical, 1 Jai Radhe Sales

EXCIPIENTS BY APPLICATIONS

68 Topical, 62 Solubilizers, 50 Coating Systems & Additives, 35 Parenteral, 35 Fillers, Diluents & Binders, 33 Controlled & Modified Release, 33 Thickeners and Stabilizers, 23 Film Formers & Plasticizers, 22 Emulsifying Agents, 21 Direct Compression, 18 Taste Masking, 17 Surfactant & Foaming Agents, 17 Granulation, 14 Co-Processed Excipients, 10 API Stability Enhancers, 9 Lubricants & Glidants, 9 Disintegrants & Superdisintegrants, 9 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

36 US Medicaid Prescriptions, 38 Finished Drug Prices

MARKET PLACE

45 APIs, 15 DOSSIERS // FDF

PATENTS

4 US Patents

4 US Patents

ANALYTICAL SOLUTION(s)

1 EDQM Standards, 1 USP Standards, 1 Other Ref. Standards

DIGITAL CONTENT

1 Data Compilation & Company Tracker #PharmaFlow, 59 News

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Aspen Pharmacare Holdings

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South Africa

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Sandoz completes acquisition of Aspen’s Japanese operations, strengthening its position in world’s third largest market for generics and off-patent medicines

Details:

The acquisition strengthens Sandoz’s presence in the hospital channel by complementing the broad Sandoz portfolio and pipeline of hospital generic and biosimilar products in Japan like Lidocaine Hydrochloride.

Lead Product(s): Lidocaine Hydrochloride

Therapeutic Area: Neurology Product Name: Lidocaine HCl-Generic

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Sandoz B2B

Deal Size: $440.0 million Upfront Cash: $330.0 million

Deal Type: Acquisition January 31, 2020

RDD 2024

Not Confirmed

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Sustained Therapeutics

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U.S.A

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Sustained Therapeutics Announces Second Phase II Trial of New Drug Platform

Details:

ST-01 is a controlled release formulation of lidocaine, a local anesthetic used in a wide variety of superficial and invasive procedures, it works by blocking sodium channels preventing pain signals at the nerve endings. It is being developed for acute post-operative pain.

Lead Product(s): Lidocaine Hydrochloride

Therapeutic Area: Neurology Product Name: ST-01

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2023

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SINTETICA SA

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Switzerland

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Sintetica US Launches Lidocaine Hydrochloride Injection, USP 1%, 2% and 4%

Details:

Lidocaine hydrochloride is a local anesthetic used in a wide variety of superficial and invasive procedures, it works by blocking sodium channels and thus decreasing the rate of contractions of the heart.

Lead Product(s): Lidocaine Hydrochloride

Therapeutic Area: Neurology Product Name: Lidocaine Hydrochloride-Generic

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 27, 2023

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Amneal Pharmaceuticals

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U.S.A

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Amneal Receives Abbreviated New Drug Application Approval for Lidocaine Patch, 5%

Details:

Amneal has received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration (FDA) for a generic version of Lidocaine Patch, 5%. Lidocaine Patch, 5% is the generic version of Lidoderm Patch, 5% for treatment of post-herpetic neuralgia.

Lead Product(s): Lidocaine Hydrochloride

Therapeutic Area: Neurology Product Name: Lidocaine HCl- Generic

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2020

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