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Details for Patent: 6,960,561

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Patent 6,960,561 protects APIDRA and APIDRA SOLOSTAR and is included in one NDA.

This patent has forty-two patent family members in thirty-two countries.

Summary for Patent: 6,960,561

Title: Zinc-free and low-zinc insulin preparations having improved stability
Abstract:The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
Inventor(s): Boderke; Peter (Frankfurt am Main, DE)
Assignee: Aventis Pharma Deutschland GmbH (Frankfurt am Main, DE)
Application Number:10/102,862
Patent Claim Types:
see list of patent claims
Composition; Formulation; Process; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 10th percentile
Forward Citations: 6th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYes6,960,561► subscribeY METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYes6,960,561► subscribeY METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXNo6,960,561► subscribeY METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
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Foreign Priority and PCT Information for Patent: 6,960,561

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany101 14 178Mar 23, 2001

Non-Orange Book Patents for Patent: 6,960,561

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
7,696,162Zinc-free and low-zinc insulin preparations having improved stability► subscribe
7,205,276Zinc-free and low-zinc insulin preparations having improved stability► subscribe
7,205,277Zinc-free and low-zinc insulin preparations having improved stability► 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: 6,960,561

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina033059► subscribe
Argentina096376► subscribe
Austria497777► 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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