Ruling Affirms Patent Claim for Paragon BioTeck’s R-Phenylephrine Hydrochloride Formulation
Paragon becomes the first patent holder to survive a post grant review challenge
PORTLAND, Ore., Nov. 21, 2016 (SEND2PRESS NEWSWIRE) – Paragon BioTeck, Inc., (Paragon) announces a monumental ruling handed down by the United States Patent and Trademark Office affirming claims made by Paragon in the patent for its R-phenylephrine hydrochloride formulation. Paragon is a privately held pharmaceutical and medical device company specializing in the development and commercialization of ophthalmic pharmaceuticals, devices and therapies.
In late 2015, Altaire Pharmaceuticals, Inc., sought to invalidate Paragon’s patent that claims a method of maintaining purity of the formulation. In only the fourth written decision by the Patent Trial and Appeals Board, the ruling affirms that the petition by Altaire Pharmaceuticals was without merit.
“While our belief in the strength of our patent was never in doubt, this is a tremendous win for Paragon BioTeck. This continues to reaffirm our belief and company mission behind the science and products we develop,” said Patrick H. Witham, President and CEO of Paragon.
Paragon is strongly dedicated to addressing unmet and underserved medical needs through product development that is based on cutting-edge science. Since its inception, Paragon has sought to partner with leading scientists and thinkers to drive innovations that advance patient care and improve the quality of lives around the world.
The patent ruling both reinforces the strong science underlying the formulation of Paragon’s Phenylephrine Hydrochloride Ophthalmic Solution and substantiates the operational philosophy of the company.
Phenylephrine hydrochloride is widely used by eye care professionals to attain mydriasis (dilation of the pupil) for conducting an ocular examination. It is an indispensable tool for the early detection, diagnosis and treatment of serious eye diseases and is vital in managing ocular health.
About Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.
Phenylephrine Hydrochloride Ophthalmic Solution Important Safety Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%, is contraindicated in patients with hypertension or thyrotoxicosis, as well as in pediatric patients under the age of one due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%, should not be used in these patients. Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% and 2.5% is for topical ophthalmic use only, and not for injection.
Serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, some fatal, and significant elevations in blood pressure have been reported. Caution is advised in pediatric patients less than five years of age and in patients with elevated blood pressure, cardiovascular disease or hyperthyroidism. Blood pressure should be monitored in patients with cardiovascular or endocrine disease. Rebound miosis has been reported one day after instillation.
Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision and photophobia. Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
About Paragon BioTeck, Inc.
Paragon BioTeck, Inc., is a privately held pharmaceutical and medical device company specializing in the development and commercialization of ophthalmic pharmaceuticals, devices and therapies. Paragon’s portfolio of products is designed to protect and preserve eyesight and deliver comfort to the eyes. These products include the Comfortear® Lacrisolve™ 180 Absorbable Punctum Plug, Comfortear® Punctum Plug, the preservative-free ilast® range of products and their FDA-approved Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%.
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