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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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Contezolid

New Drug Approvals

Contezolid (4), also referred to as MRX-I, is an orally administered oxazolidinone antibacterial agent developed by Shanghai MicuRx Pharmaceutical Co. 34) MicuRx Pharmaceuticals. 35) MSD Pharmaceuticals. 2011, 46, 1027−1039. (38) SYN Contezolid (Youxitai). 2021, 34, 1348−1354. (33) 33) Hoy, S. Contezolid: First approval.

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] Jump up to: a b c d e “Gepirone – Fabre-Kramer Pharmaceuticals” AdisInsight. Jump up to: a b Fabre LF, Brown CS, Smith LC, Derogatis LR (May 2011). 1] It is taken orally. [1]

FDA
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Redafamdastat

New Drug Approvals

1] It was being developed by Jazz Pharmaceuticals for the treatment of alcoholism , pain , and post-traumatic stress disorder (PTSD) and reached phase 2 clinical trials. [2] February 2011). 2011 Feb 10;2(2):91-96. 2011 Jul;338(1):114-24. 2] [3] However, development of the drug was discontinued in December 2023. [2]

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PRITELIVIR MESYLATE

New Drug Approvals

Salt Formation: The pritelivir free base is then reacted with methanesulfonic acid to form the mesylate salt, which is the active pharmaceutical ingredient (API). Amide Coupling: The resulting carboxylic acids are coupled with thiazolyl sulfonamides using amide coupling conditions to form the pritelivir molecule. 152 (8): 1489–500.

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Landiolol

New Drug Approvals

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. June 2011). June 1992).

FDA
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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

Drug patents are a form of intellectual property protection that grants pharmaceutical companies exclusive rights to manufacture, sell, and profit from their innovations for a set period. Types of Patents in the Pharmaceutical Industry Not all patents are created equal. File too late, and you risk someone else beating you to the punch.