CutisPharma Inc.has received approval from the United States Patent and Trademark Office for its patent on a method for the preparation, storage and dispensing of compounded suppositories.


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CutisPharma earns patent for suppository compounding

October 27th, 2010

WOBURN, Mass. – CutisPharma Inc.has received approval from the United States Patent and Trademark Office for its patent on a method for the preparation, storage and dispensing of compounded suppositories.

The specialty pharmaceutical company said Wednesday that the patent (US 7,815,929) is currently used in a container for its FIRST Progesterone Vaginal Suppository Unit-of-Use Prescription Compounding Kit product line, which includes FIRST Progesterone VGS 25 mg, 50 mg, 100 mg, 200 mg and 400 mg dosages.

According to CutisPharma, the kits are made for a single patient and include preweighed progesterone, a suppository base and a disposable container/mold for the preparation, storage and dispensing of the suppositories. A single NDC number assigned for the entire kit aids the third-party reimbursement process and reduces audit-related adjustments, the company added.

"By its very nature, the process of compounding suppositories is cumbersome, time-consuming an,d in general, without adequate compensation," Dr. Indu Muni, founder, chairman and chief executive officer of CutisPharma, said in a statement. "Our container (suppository mold) and the method for suppository compounding is user-friendly and time-saving for a pharmacy. Our suppository mold is also customer friendly because the take-home molds are especially designed to not only maintain the integrity of each suppository once compounded, but also provide convenient patient dispensing.'

CutisPharma estimates that over 1.5 million progesterone suppository prescriptions are written in the United States annually, representing a potential of nearly $100 million at the retail level. The company said the kit gives a pharmacy an easy entry into this market.

Using FIRST VGS kits, pharmacists can compound a prescription for 30 vaginal suppositories four to five times faster than those prepared by the traditional method using a metal suppository mold or polystyrene shells, CutisPharma said, citing a study conducted by researchers at the Massachusetts College of Pharmacy and Health Science and published in the International Journal of Pharmaceutical Compounding last year.

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