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Details for Patent: 6,036,976

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Patent 6,036,976 protects LUPANETA PACK, LUPRON DEPOT, and LUPRON DEPOT-PED, and is included in five NDAs.

This patent has thirteen patent family members in eight countries.

Summary for Patent: 6,036,976

Title: Sustained release microspheres and preparation thereof
Abstract:Disclosed is a method of producing microspheres which comprises subjecting a w/o/w emulsion or o/w emulsion to an in-water drying method under the following conditions: 1) the amount of microspheres per m.sup.3 of an external aqueous phase is about 0.1 to about 500 kg, 2) the square root of the area (unit: m.sup.2) of the liquid surface in contact with the gas phase is about 0.2 to about 4.5 per the cube root of the volume (unit: m.sup.3) of an external aqueous phase, 3) the w/o/w emulsion or o/w emulsion is replaced at the replacement frequency of about 0.01 to about 10 times/minutes, 4) a gas is blown to the w/o/w emulsion or o/w emulsion at the gas transfer rate near the liquid surface of about 0.1 to about 300 m/second, and 5) the gas is replaced at the replacement frequency of not less than about 0.5 times/minutes; and the method of the present invention increases the rate of solvent removal from microspheres in in-water drying, reduces the amount of solvent in microspheres in a short time.
Inventor(s): Takechi; Nobuyuki (Osaka, JP), Ohtani; Seiji (Osaka, JP), Nagai; Akihiro (Osaka, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:09/154,164
Patent Claim Types:
see list of patent claims
Process; Delivery; Composition; Compound;
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
Abbvie Endocrine
LUPANETA PACK
leuprolide acetate; norethindrone acetate
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-001Dec 14, 2012RXNo6,036,976<disabled>Y
Abbvie Endocrine
LUPANETA PACK
leuprolide acetate; norethindrone acetate
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696-002Dec 14, 2012RXYes6,036,976<disabled>Y
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION019732-001Jan 26, 1989RXYes6,036,976<disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020708-001Mar 7, 1997RXYes6,036,976<disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-001Dec 22, 1995RXYes6,036,976<disabled>
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Non-Orange Book Patents for Patent: 6,036,976

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
5,851,451 Production of microspheres<disabled in preview>
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International Patent Family for Patent: 6,036,976

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
Japan3191004Jul 23, 2001
Germany69622006Oct 24, 2002
Denmark1142567Feb 06, 2006
JapanH09221418Aug 26, 1997
Germany69635249Jul 13, 2006
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ISSN: 2162-2639

Preferred citation:

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

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