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Details for Patent: 7,943,178

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Patent 7,943,178 protects AFREZZA and is included in one NDA.

This patent has fifty-five patent family members in seventeen countries.

Summary for Patent: 7,943,178

Title:Methods and compositions for delivering peptides
Abstract: Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
Inventor(s): Steiner; Solomon S. (Mount Kisco, NY), Woods; Rodney J. (New Hampton, NY), Sulner; Joseph W. (Paramus, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:12/635,380
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery; Composition; Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 125th percentile
Forward Citations: 10th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-001Jun 27, 2014RXNo7,943,178► subscribeY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-002Jun 27, 2014RXYes7,943,178► subscribeY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.
Mannkind
AFREZZA
insulin recombinant human
POWDER;INHALATION022472-003Apr 17, 2015RXNo7,943,178► subscribeY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.
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Non-Orange Book Patents for Patent: 7,943,178

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
9,006,175Potentiation of glucose elimination► subscribe
8,889,099Methods and compositions for delivering peptides► subscribe
7,648,960Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles► 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: 7,943,178

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office2280004► subscribe
European Patent Office2280020► subscribe
European Patent Office2280021► 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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