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Raptor gets 5th patent for PROCYSBI in FDA Orange Book

PROCYSBI has been granted additional U.S. orphan exclusivity

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Raptor's most recent patent expires in June 2034.

Raptor Pharma (NASDAQ:RPTP) jumped in morning trading after the biopharmaceutical company obtained a fifth patent for PROCYSBI in the FDA Orange Book.

Shares gained 11% to $3.83 at 11:03 a.m. in New York.

U.S. PROCYSBI patent, number 9,233,077, is now listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, the Novato, California-based company said in a statement on Monday.

The patent is entitled “Delayed Release Cysteamine Bead Formulation, and Methods of Making and Using Same.” It covers the enteric coated micro-bead formulation of PROCYSBI as well as other related formulations.

This patent expires in June 2034.

Raptor Pharmaceutical now has five patents for PROCYSBI listed in the Orange Book, including four issued in the last three months.

In addition, the U.S. Food and Drug Administration (FDA) granted additional orphan drug designation for PROCYSBI (cysteamine bitartrate) delayed-release capsules to treat nephropathic cystinosis in children aged 2 to 6 years old.

The FDA approved the expanded use of PROCYSBI in this patient population in August 2015 after initially approving PROCYSBI for the treatment of nephropathic cystinosis in adults and children 6 years and older in April 2013.

Orphan drug designation for PROCYSBI has been granted post-approval, conferring the benefit of seven years of orphan drug exclusivity for the treatment of nephropathic cystinosis in pediatric patients 2 to 6 years of age.

The seven-year term of orphan exclusivity for this recently approved pediatric indication will expire in August 2022.

The FDA's Orphan Drug Designation program grants orphan status to drugs intended for the treatment of rare disorders affecting fewer than 200,000 people in the U.S.

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