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Addressing Generic Drug Market Challenges: Strategies for Stability and Affordability

Drug Patent Watch

The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. These challenges can lead to drug shortages, price spikes, and reduced affordability for patients and payers.

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Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage.

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Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Why Generic Drugs Matter Generic drugs are the Robin Hoods of the pharmaceutical world, stealing from the rich (brand-name drugs) and giving to the poor (our wallets).

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Risk Management Strategies for Generic Drug Development

Drug Patent Watch

Navigating the Complex World of Generic Drug Development: Risk Management Strategies to Know As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. One of the biggest risks generic drug developers face is patent infringement.

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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. 11 Must-know FAQs about the Drug Approval Process in Japan. Freyr Solutions.

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In the News: August 2021 Regulatory and Development Updates

Camargo

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. Final Regulation Issued for “Intended Use”.