FDA Grants Extra Patent Time for ADZYNMA Drug Review
Published Date: 12/29/2025
Notice
Summary
The FDA has set the official review period for ADZYNMA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ADZYNMA and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until early 2026 to speak up—so keep an eye on those deadlines!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Applicants Seek Specific Extension Lengths
The patent applicants for ADZYNMA have applied to the USPTO seeking patent term extensions of 702 days, 1,346 days, 1,479 days, 1,916 days, or the statutory maximum of 5 years. The USPTO will apply statutory limitations in calculating the actual extension that may be granted.
Regulatory Review Period Set at 4,059 Days
FDA determined that ADZYNMA's regulatory review period is 4,059 days total, consisting of 3,821 days in the testing phase and 238 days in the approval phase. This determination (using IND effective date September 30, 2012; BLA submission March 17, 2023; approval November 9, 2023) establishes the maximum potential length of any patent term extension that may be awarded for this product.
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Key Dates
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