Pediatric exclusivity is a widely sought-after form of patent protection that can add 6 months onto any existing non-expired listed patent protection (not the patent itself, because only the Patent and Trademark Office can extend a patent, but, rather, it is a period of protection during which the FDA cannot approve a generic for the drug). When granted, it attaches to any existing unexpired period market exclusivity (3-year Hatch-Waxman, 5-year new chemical entity and 7-year orphan drug exclusivity); thus its value can be quite considerable. Just think of a $3 billion/year drug product that gets 6 month months of market protection. A $1.5 billion windfall is nothing to sneeze at!
The FDA has updated its pediatric exclusivity page (here); a search of the document reveals 9 different products received pediatric exclusivity during 2015. A look at the products, the firms, and indications are provided in the table below.
Pediatric Exclusivity Awarded 2015
Drug Firm Indication
| Asenapine | Forest Labs | Schizophrenia and Bipolar Disease |
| Atazanavir | Bristol-Myers Squibb | HIV Infection |
| Azelastine | Meda | PAR and SAR |
| Azelastine/fluticasone | Meda | PAR and SAR |
| Bortezomib | Millennium | Acute Lymphocytic Leukemia (ALL) |
| Eltrombopag | Novartis | Thrombocytopenia in children with chronic idiopathic thrombocytopenia purpura (ITP) |
| Erlotinib | OSI Pharmaceuticals | Treatment of cancer (recurrent ependymoma) |
| Rufinamide | Eisai | Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) |
| Sumatriptan/Naproxen | GSK-Pernix | Migrane |
The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring? We will see, but it is certain that the industry will be looking to protect their products, and pediatric exclusivity is certainly a good way to do that!
