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Details for Patent: 6,294,196

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Patent 6,294,196 protects BONIVA and is included in one NDA. There have been two Paragraph IV challenges on Boniva. 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 forty-one patent family members in thirty-one countries.

Summary for Patent: 6,294,196

Title: Pharmaceutical composition containing diphosphonic acid or salt thereof
Abstract:The invention relates to a solid pharmaceutical form of administration containing a diphosphonic acid or a physiologically compatible salt thereof as the active substance, wherein the active substance is present in granulate form, optionally together with pharmaceutical adjuvants in the inner phase, and the outer phase contains a lubricant in the form of less than 5% by weight of stearic acid relative to the total weight of the form of administration.
Inventor(s): Gabel; Rolf-Dieter (Schwetzingen, DE), Preis; Walter (Neustadt, DE), Woog; Heinrich (Laudenbach, DE)
Assignee: Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:09/413,990
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 26th 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
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-001May 16, 2003DISCNNo6,294,196► subscribeY
Hoffmann La Roche
BONIVA
ibandronate sodium
TABLET;ORAL021455-002Mar 24, 2005RXYes6,294,196► subscribeY
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Foreign Priority and PCT Information for Patent: 6,294,196

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
98119102Oct 09, 1998

Non-Orange Book Patents for Patent: 6,294,196

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
6,627,221 Pharmaceutical composition containing diphosphonic acid or salt thereof► 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: 6,294,196

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina014081► subscribe
Argentina047815► subscribe
Argentina069942► 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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