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Tag: Hatch-Waxman Act

Patent Litigation: How Authorized Generics Reduce Generic Drug Competition

Patent Litigation: How Authorized Generics Reduce Generic Drug Competition

Daniel Whiteside Dec 19 13 Comments

Authorized generics let brand drug companies launch their own generic versions, undercutting independent competitors during the 180-day exclusivity window. This practice reduces price drops, discourages patent challenges, and harms true competition in the pharmaceutical market.

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Patent Term Restoration: Legal Ways to Extend Drug and Medical Device Exclusivity

Patent Term Restoration: Legal Ways to Extend Drug and Medical Device Exclusivity

Daniel Whiteside Dec 11 16 Comments

Patent term restoration lets drugmakers recover lost patent time due to FDA approval delays. Learn how the Hatch-Waxman Act works, who qualifies, and why it's critical for pharmaceutical innovation.

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