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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

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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Innovative Approaches to Generic Drug Development: Case Studies

Drug Patent Watch

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). They offer the same therapeutic benefits as their brand-name counterparts but at a fraction of the cost. But how do companies develop these cost-effective alternatives?

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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. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

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The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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The Role of Pharmacokinetics in Generic Drugs

Drug Patent Watch

Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs. PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles.

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The drug industry continues to dare regulation

World of DTC Marketing

didn’t just offer to pay for the drug’s development cost so that the price could be set very low, but it’s about investors who penalized the company stock when they learned that COVID might be on the decline. At this point, one must wonder why the U.S. About those copay cards.

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Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging. There are significant rebates associated with the sort of branded versions here.”.

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