Orange Book Update – Patent Submission Date

It's been quite a while any changes were made in FDA Orange Book. It is welcoming to see FDA is adding/updating NDA holders' patent submission date in Orange Book. At the time of NDA submission, NDA applicants are required to indicate the patents to be listed in Orange Book. Previously, this date is only known …

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FDA BE Guidance – Injectables

To facilitate generic drug product availability and assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs. After more than a decade in action, this …

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Resources for Topical Generic Product Development

With many blockbuster brand drugs at or near the edge of the so called “patent cliff”, and with significant technical hurdles in biosimilar development, some generic companies are shifting their attention to additional dosage forms or niche products to create product portfolio diversity. One of the market segments that offers multiple sub-billion-dollar product opportunities is …

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