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Last Updated: November 21, 2019

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Details for Patent: 8,323,630

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Summary for Patent: 8,323,630
Title:Self-preserved aqueous pharmaceutical compositions
Abstract: The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.
Inventor(s): Kabra; Bhagwati P. (Euless, TX), Chowhan; Masood A. (Arlington, TX), Schneider; L. Wayne (Crowley, TX), Han; Wesley Wehsin (Arlington, TX)
Assignee: Alcon Research, Ltd. (Fort Worth, TX)
Application Number:13/086,950
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,323,630
Patent Claim Types:
see list of patent claims
Formulation;

Drugs Protected by US Patent 8,323,630

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis TRAVATAN Z travoprost SOLUTION/DROPS;OPHTHALMIC 021994-001 Sep 21, 2006 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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