Benefits of FDA Pediatric Exclusivity

Benefits of FDA Pediatric Exclusivity

Just two weeks after suffering defeat in U.K. patent battles involving pain drug Lyrica (pregabalin), pharma giant Pfizer has secured FDA Pediatric Exclusivity, extending their U.S. market exclusivity for Lyrica through June 30, 2019.

Pediatric Exclusivity is a powerful tool for drug developers, delaying FDA ANDA and 505(b)(2) approvals six months after patent expiration.

The marketing exclusivity extends beyond the studied drug to include all formulations, dosage forms, and indications – as long as products have existing exclusivity or patent life and contain the same active moiety.

Products that qualify for Pediatric Exclusivity typically must have remaining patent life or remaining exclusivity; there are exceptions for products that are granted new exclusivity for a supplemental application. Although Pediatric Exclusivity can affect regulatory exclusivities for biologics, it has no effect on biologic patents.

Six-Month Exclusivity Bonus Encourages Pediatric Studies

Under Section 505A of the Food, Drug, and Cosmetic Act (FDCA), the FDA can issue written requests for pediatric studies if it agrees that a drug’s pediatric use may produce health benefits. As an incentive to conduct these studies, §505(A) offers six months of marketing exclusivity, “Pediatric Exclusivity.”

For small molecule products gaining the benefit of Pediatric Exclusivity, the FDA cannot grant final approval to generic applications before the expiration of the 6-month Pediatric Exclusivity period (following patent expiration) unless the patent is invalid or non-infringed. Accordingly, the patent benefit associated with Pediatric Exclusivity does not come from a change in the patent’s expiration. Instead, it comes from delaying the FDA’s final approval date following patent expiration.

The six-month period also attaches to the end of existing regulatory exclusivities, such as New Chemical Entity (NCE) Exclusivity, New Product Exclusivity, and Orphan Drug Exclusivity. The 6-month period of Pediatric Exclusivity is reflected in the patent and regulatory exclusivity information listed in the Orange Book.

Specifically, the six-month Pediatric Exclusivity applies as follows:

  • Five-year NCE Exclusivity becomes five years and six months.
  • Three-year New Product Exclusivity becomes three years and six months.
  • Four-year prohibition on generic drug application submissions (under FDCA §505(j)) containing Paragraph IV certification becomes four years and six months. The same applies to applications filed under FDCA §505(b)(2) (requiring investigations for approval of a new indication for, or other change from, a listed drug).
  • Seven-and-a-half-year duration of the stay of FDA approval if a generic sponsor files an application containing a Paragraph IV certification at the expiration of the four-year prohibition (or before the end of the five-year NCE exclusivity) becomes eight years.
  • Period during which FDA may not approve a generic application (for a patent that is invalid or not infringed) is extended by six months after the patent expiration date (including patent extensions).
  • Seven-year Orphan Drug Exclusivity becomes seven years and six months.
  • The 12-year Reference Product Exclusivity becomes 12 years and six months.

Avoiding the impact of Pediatric Exclusivity is not easy for AMDA applicants. They would have to prove patent invalidity or non-infringement, get the listing removed from the Orange Book, or get a waiver from the ANDA sponsor.

Pediatric Exclusivity and Supplemental Applications

Products without patents or remaining exclusivity generally don’t qualify for Pediatric Exclusivity, but the FDA may grant Pediatric Exclusivity if the supplemental application qualifies for a new exclusivity period.

For example, an application to extend an approved adult indication to the pediatric population for a product with no patent life or remaining exclusivity could obtain Pediatric Exclusivity as long as new clinical studies of safety and efficacy are required for approval.

Here, the pediatric supplement would earn three years of New Product Exclusivity plus six months of Pediatric Exclusivity.

Biologics Patents and Pediatric Exclusivity

As mentioned earlier, the patent benefit associated with Pediatric Exclusivity comes from delaying FDA approval for six months following the patent expiration (where the patent is valid or not infringed).

But for biologics, there is no patent-related prohibition on FDA approval of biosimilar applications. This means Pediatric Exclusivity has no effect on rights associated with biologics patents.

In addition, although the Affordable Care Act (Title VII, Subtitle A – Biologics Price Competition and Innovation) applies the six-month Pediatric Exclusivity period to most of the relevant time periods applicable to biosimilar applications under PHS Act §351(k), it does not apply the six-month period to the four-year prohibition on biosimilar application submissions.

Therefore, a sponsor can still file a biosimilar application at four-years after innovator biological product approval - even if it references a biologic product with 12 years and six months of Reference Product Exclusivity due to the added Pediatric Exclusivity.

How to Qualify for FDA Pediatric Exclusivity

Thinking of pursuing this six-month exclusivity extension? To qualify, applicants must:

  1. Obtain a Written Request containing a detailed description of the studies and the time frame needed for completion.
  2. Submit study reports (typically in the form of a new drug application, as a supplement to an approved application, or as an amendment to a pending application).
  3. Meet the conditions (including time frame and study terms) of the Written Request.

Remember, approval isn’t tied to labeling information on pediatric use based on the studies conducted. The FDA may grant pediatric exclusivity merely upon acceptance of the study reports.


Gregory J. Glover MD JD is a patent attorney and non-practicing physician. A noted expert on developments and emerging conflicts in the pharmaceutical industry, Greg is an expert on regulatory IP issues.

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