Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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Licensing Licensing Branding Drugs 96

Drug Patent Watch

DECEMBER 30, 2024

Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan. The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan.

Generic Drugs 52

Generic Drugs Bioequivalency Development Drugs 52

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For more information, please download our white paper.

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Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. MYTH: Treatment-experienced patients cannot be prescribed biosimilars.

Production 78

Production Insulin Branding Generic Drugs 78

Druggist

MARCH 25, 2021

Cerelle and Cerazette are two brands of daily progestogen-only pill (POP), also known as mini-pill. In recent years prescribing of Cerazette in NHS decreased, in place of other brands, including Cerelle. Do generic, and branded drugs produce exactly the same effect? . Summary of the post: Cerelle vs Cerazette: are they the same?

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug.

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Generic Drugs Drugs Branding Bioequivalency 89