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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for Patent: 6,652,885

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Which drugs does patent 6,652,885 protect, and when does it expire?

Patent 6,652,885 protects AFREZZA and is included in one NDA.

This patent has sixty-six patent family members in seventeen countries.

Summary for Patent: 6,652,885
Title: Purification and stabilization of peptide and protein pharmaceutical agents
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, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. 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 a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. The charge on the insulin molecule is masked by hydrogen bonding it to the diketopiperazine, thereby enabling the insulin to pass through the target membrane. 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 (Danbury, CT)
Application Number:10/224,761
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;

Drugs Protected by US Patent 6,652,885

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-001 Jun 27, 2014 RX Yes No   Start Trial   Start Trial ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-002 Jun 27, 2014 RX Yes Yes   Start Trial   Start Trial ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.   Start Trial
Mannkind AFREZZA insulin recombinant human POWDER;INHALATION 022472-003 Apr 17, 2015 RX Yes No   Start Trial   Start Trial ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 6,652,885

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 411040   Start Trial
Austria 471154   Start Trial
Austria 545652   Start Trial
Australia 2005202230   Start Trial
Australia 2006230576   Start Trial
Australia 2008229952   Start Trial
Australia 2011200675   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
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Baxter
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McKinsey

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