Tentative approval from the FDA means your generic drug is ready to sell - but you can't launch yet due to patents. Learn how litigation, timing, and paperwork determine whether you win market entry or lose millions.
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Paragraph IV certifications let generic drug makers challenge brand patents before launching. This legal tool under the Hatch-Waxman Act has saved U.S. consumers over $2 trillion since 1984 by speeding up generic access.
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