2 more US patents expected for Catalyst’s Firdapse in next 2 months

New patents for sole approved oral LEMS therapy would expire in mid-2032

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by Mary Chapman |

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The U.S. Patent and Trademark Office has sent a notice of allowance for two additional patents for Firdapse (amifampridine), Catalyst Pharmaceuticals’ approved therapy for Lambert-Eaton myasthenic syndrome (LEMS), for claims related to its bioavailability under fasting and fed dosing conditions.

Catalyst, which has licensing rights in North America for the medication, originally developed by BioMarin Pharmaceutical, expects the patents to be granted within two months.

If granted, the new patents — which would expire in mid-2032 — would bring the total patent count for Firdapse to eight.

A notice of allowance is a document sent to a patent application for the U.S. Patent and Trademark Office after a decision has been made to issue the requested patent. It is a final step in the protracted patent application process.

“This milestone reaffirms our unwavering dedication to advancing our core objectives, which are crucial in strengthening and maintaining the ongoing commercial success of our flagship product, Firdapse,” Patrick J. McEnany, Catalyst’s chairman and CEO, said in a company press release. “Aligned with our portfolio strategy, we remain committed to advancing our core objectives to reinforce and safeguard the sustained commercial viability of Firdapse, which currently benefits from patent exclusivity protection in the United States until 2037.”

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2 new patents would bring Firdapse’s total to 8

Firdapse is the first and sole approved oral medication available in the U.S. for the symptomatic treatment of LEMS, an autoimmune disorder that primarily affects lower limb muscles. The therapy, available for children and adults in the U.S., works to enhance muscle strength.

The new patents are for claims associated with Firdapse’s bioavailability, or how well the medication is absorbed by the body, when administered under fast and fed conditions. Previous patents have covered the use of Firdapse in people who metabolize, or process, the therapy differently due to genetic variations.

“These patent allowances strengthen our cumulative understanding of the uniqueness of Firdapse and bolster its strong intellectual property estate offering enhanced patent protection,” said Steven Miller, PhD, Catalyst’s chief operating officer and chief scientific officer.

In expectation of the two new patents, Catalyst is preparing to submit a request for their inclusion in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This book lists products the regulatory agency has approved as safe and effective.

These patent allowances strengthen our cumulative understanding of the uniqueness of Firdapse and bolster its strong intellectual property estate offering enhanced patent protection.

Catalyst now is also seeking to increase the maximum recommended daily dosage of Firdapse to 100 mg.

The medication’s label permits a maximum daily dosage of 80 mg in adults and children weighing at least 45 kg (99 pounds). The dosage for children weighing less than 45 kg may not exceed 40 mg daily.

The company’s request to increase Firdapse’s maximum daily dosage is under regulatory review, with a decision expected to be announced next year.