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news.Agile Therapeutics, Inc., a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for additional patent claims covering dosing regimens using the Company's lead product candidate Twirla (ethinyl estradiol and levonorgestrel transdermal system (AG200-15)), currently in Phase 3 development.
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The allowed patent, which is published as US Patent Application 20140072615, is based on Agile’s prior patent, US 7,384,650, covering the formulation for Twirla.
"We believe the allowance of this patent represents another step towards our goal of protecting Twirla, and future product line extensions," said Al Altomari, Chief Executive Officer and President of Agile. "We intend to continue our efforts to expand our intellectual property portfolio protecting our proprietary Skinfusion® transdermal technology."
Agile will submit information regarding this patent to the FDA for inclusion in the FDA’s Orange Book if the Company’s New Drug Application for Twirla is approved.
The Company has multiple additional patents and applications on file, all relating to further advances in Skinfusion transdermal delivery system.