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Details for Patent: 6,379,703

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Patent 6,379,703 protects VIVITROL and RISPERDAL CONSTA and is included in two NDAs. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for RISPERDAL CONSTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ten patent family members in nine countries.

Summary for Patent: 6,379,703

Title: Preparation of microparticles having a selected release profile
Abstract:An improved method for preparing microparticles that exhibit controlled release of an effective amount of an active agent over an extended period of time. More particularly, a method is provided for preparing microparticles having a selected release profile for release of active agent contained in the microparticles. By adjusting the degree of drying that is performed during the preparation of the microparticles, the release profile can be controlled. By performing no intermediate drying, an initial burst and a substantially linear release profile is achieved. By performing substantially complete intermediate drying, an initial lag phase and a substantially sigmoidal release profile is achieved.
Inventor(s): Lyons; Shawn L. (Cincinnati, OH), Ramstack; J. Michael (Lebanon, OH), Wright; Steven G. (Madeira, OH)
Assignee: Alkermes Controlled Therapeutics Inc., II (Cambridge, MA)
Application Number:09/722,335
Patent Claim Types:
see list of patent claims
Process; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYes6,379,703► subscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007RXNo6,379,703*PED► subscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-001Oct 29, 2003RXYes6,379,703*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,379,703

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
6,596,316 Preparation of microparticles having a selected release profile► subscribe
6,194,006 Preparation of microparticles having a selected release profile► 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: 6,379,703

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria308977► subscribe
Australia3117800► subscribe
Australia759214► 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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