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Details for Patent: 9,023,397

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Patent 9,023,397 protects FOSRENOL and is included in one NDA. There have been two Paragraph IV challenges on Fosrenol.

This patent has eight patent family members in eight countries.

Summary for Patent: 9,023,397

Title:Capsule and powder formulations containing lanthanum compounds
Abstract: The present invention includes an oral pharmaceutical capsule comprising a shell, lanthanum carbonate or lanthanum carbonate hydrate, and a lubricant such as talc, wherein the shell encapsulates the lanthanum carbonate or its hydrate and the lubricant. Capsule shells comprise, for example, gelatin. The present invention also includes an oral pharmaceutical powder comprising lanthanum carbonate or lanthanum carbonate hydrate and a pharmaceutically acceptable excipient. The oral pharmaceutical capsules and powders of the present invention can be administered to treat a patient at risk of or suffering from hyperphosphatemia, at risk of or suffering from chronic kidney disease (CKD), at risk of or suffering from soft tissue calcification associated with CKD, or at risk of or suffering from secondary hyperparathyroidism.
Inventor(s): Pierce; David (Hertfordshire, GB), Ferdinando; Josephine Christine (Tadley, GB), Davies; Peter Neil (Basingstoke, GB)
Assignee: Shire LLC (Florence, KY)
Application Number:14/507,551
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 9th 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
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-002Sep 24, 2014RXYes9,023,397► subscribeY
Shire Dev Llc
FOSRENOL
lanthanum carbonate
POWDER;ORAL204734-001Sep 24, 2014RXNo9,023,397► subscribeY
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Non-Orange Book Patents for Patent: 9,023,397

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
8,980,327Capsule and powder formulations containing lanthanum compounds► subscribe
8,263,119Capsule formulations containing lanthanum compounds► subscribe
8,697,132Capsule and powder formulations containing lanthanum compounds► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 9,023,397

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea20130119960► subscribe
Japan2013544287► subscribe
Israel226020► subscribe
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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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