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Details for Patent: 6,036,976

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Patent 6,036,976 protects LUPRON DEPOT, LUPRON DEPOT-PED, and LUPANETA PACK, 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 Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 9th percentile
Forward Citations: 0th percentile
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 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>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-002May 30, 1997RXYes6,036,976<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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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: 6,036,976

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria219662<disabled in preview>
Austria305772<disabled in preview>
Canada2192782<disabled in preview>
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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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