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Details for Patent: 8,268,299

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Patent 8,268,299 protects TRAVATAN Z and is included in one NDA. There has been one Paragraph IV challenge on Travatan Z. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Summary for Patent: 8,268,299

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 borat 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:11/858,781
Patent Claim Types:
see list of patent claims
Patent Metrics:
Field: Pharmaceuticals
Back Citations: 37
Forward Citations: 0
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Alcon Pharms Ltd
SOLUTION/DROPS;OPHTHALMIC021994-001Sep 21, 2006RXYes8,268,299<disabled>Y
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International Patent Family for Patent: 8,268,299

Country Document Number Publication Date
Argentina062929Dec 17, 2008
Austria531358Nov 15, 2011
Australia2007299727Mar 27, 2008
BrazilPI0717067Sep 24, 2013
Canada2606370Mar 21, 2008
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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