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Patents are granted by the U.S. Patent and Trademark Office at any time during a drugs development and may include a wide range of claims. 1. Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Patent 6,943,166 Issued: September 13, 2005 Inventors: Pullman; William Ernest Whitaker; John Steven Assignees: Lilly ICOS LLC. The present invention relates to highly selective phosphodieterase PDE enzyme inhibitors and to their use in pharmaceutical articles of manufacture. In particular, the present invention relates to potent inhibitors of cyclic guanosine 3,5-monophosphate specific phosphodiesterase type 5 PDE5 that when incorporated into a pharmaceutical product at about 1 to about 20 mg unit dosage are useful for the treatment of sexual dysfunction.Patent expiration dates: 1.1. April 26, 2020 Patent use: TREATMENT OF ERECTILE DYSFUNCTION 1.2. April 26, 2020 Patent use: TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS
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Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. 1. Exclusivity expiration dates: 1.1. February 15, 2021- INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY 1.2. August 15, 2021- PEDIATRIC EXCLUSIVITY
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