Tag: Bioequivalencestudies

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The Brivaracetam Generic Opportunity: Patent Status, Market Dynamics, and Bioequivalence Study Design

Brivaracetam, commercially available as Briviact®, is an established antiepileptic medication approved for focal epilepsy management. It is used in conjunction with other medications to help control seizures. This drug is designed to offer pharmacologic differentiation from levetiracetam, including higher SV2A affinity and improved tolerability in select patients. Major patents for Briviact® are set to expire […]

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Preparing for Post-Patent Generic Launch: A Practical Guide to Bioequivalence Studies

When patents for Reference Listed Drugs (RLDs) expire, it opens the door for generic manufacturers to offer more affordable alternatives to brand-name drugs. However, successful entry into the market requires careful preparation ahead of the patent expiration. To demonstrate that a generic drug is equivalent to its branded counterpart, companies conduct thorough clinical research. This […]

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Trending Molecules and Generic Drug Opportunities: Blockbuster Drugs With Upcoming Patent Expirations (2026–2030)

The pharmaceutical industry is undergoing a major change as patent exclusivity expires for popular drugs, highlighting vast generic drug opportunities. This shift will open up a $236 billion opportunity for generic and biosimilar manufacturers between 2025 and 2030. This significant loss of patent protection means more than just the end of exclusive rights. It will […]

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