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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 are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has twenty-five patent family members in twenty-two countries.

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
Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 37th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Alcon Pharms Ltd
TRAVATAN Z
travoprost
SOLUTION/DROPS;OPHTHALMIC021994-001Sep 21, 2006RXYes8,268,299Oct 13, 2029Y
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Non-Orange Book Patents for Patent: 8,268,299

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,323,630Self-preserved aqueous pharmaceutical compositions<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
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International Patent Family for Patent: 8,268,299

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
TaiwanI394564<disabled in preview>
Taiwan200820962<disabled in preview>
Slovenia2068822<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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