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Details for Patent: 5,656,297

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Patent 5,656,297 protects NUTROPIN DEPOT and is included in one NDA.

This patent has nineteen patent family members in seven countries.

This patent has expired prematurely due to non-payment of maintenance fees. See details below.

Summary for Patent: 5,656,297

Title: Modulated release from biocompatible polymers
Abstract:The present invention relates to a composition for the modulated release of a biologically active agent. The composition comprises a biocompatible polymeric matrix, a biologically active agent which is dispersed within the polymeric matrix, and a metal cation component which is separately dispersed within the polymeric matrix, whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix. The present invention also relates to a method for modulating the release of a biologically active agent from a biocompatible polymeric matrix, comprising the steps of dissolving a biocompatible polymer in a solvent to form a polymer solution and also separately dispersing a metal cation component and a biologically active agent within the polymer solution. The polymer solution is then solidified to form a polymeric matrix, wherein at least a significant portion of the metal cation component is dispersed in the polymeric matrix separately from the biologically active protein, and whereby the metal cation component modulates the release of the biologically active agent from the polymeric matrix.
Inventor(s): Bernstein; Howard (Cambridge, MA), Zhang; Yan (Cambridge, MA), Khan; M. Amin (Downingtown, PA), Tracy; Mark A. (Arlington, MA)
Assignee: Alkermes Controlled Therapeutics, Incorporated (Cambridge, MA)
Application Number:08/237,057
Patent Claim Types:
see list of patent claims
Composition; Use; Formulation;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-001Dec 22, 1999DISCNNo5,656,297<disabled>
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-002Dec 22, 1999DISCNNo5,656,297<disabled>
Genentech
NUTROPIN DEPOT
somatropin recombinant
INJECTABLE;INJECTION021075-003Dec 22, 1999DISCNNo5,656,297<disabled>
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Premature patent expiration for: 5,656,297

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
5,656,297
NUTROPIN DEPOT
August 12, 2009

Non-Orange Book Patents for Patent: 5,656,297

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
5,413,797 Controlled release ACTH containing microspheres<disabled in preview>
6,749,866 Modulated release from biocompatible polymers<disabled in preview>
6,368,630 Modulated release from biocompatible polymers<disabled in preview>
5,912,015 Modulated release from biocompatible polymers<disabled in preview>
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International Patent Family for Patent: 5,656,297

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office0758227Feb 19, 1997
Australia688506Mar 12, 1998
World Intellectual Property Organization (WIPO)9529664Nov 09, 1995
Australia668384May 02, 1996
Austria154240Jun 15, 1997
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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