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Serving 500+ biopharmaceutical companies globally:

Merck
Dow
Argus Health
Chubb
Colorcon
US Army
Accenture
Baxter
Medtronic
Queensland Health

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,596,316

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Which drugs does patent 6,596,316 protect, and when does it expire?


Patent 6,596,316 protects VIVITROL and RISPERDAL CONSTA and is included in two NDAs.

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: 6,596,316

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:10/059,115
Patent Claim Types:
see list of patent claims
Process; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Alkermes
VIVITROL
naltrexone
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006RXYesYes6,596,316► SubscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007RXYesNo6,596,316*PED► SubscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-001Oct 29, 2003RXYesYes6,596,316*PED► SubscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003RXYesNo6,596,316*PED► SubscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 2003RXYesNo6,596,316*PED► SubscribeY
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Non-Orange Book Patents for Patent: 6,596,316

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

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan4694694► Subscribe
Japan2002534372► Subscribe
Spain2251850► Subscribe
European Patent Office1140029► Subscribe
Denmark1140029► 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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Serving 500+ biopharmaceutical companies globally:

Fuji
Colorcon
McKinsey
Healthtrust
Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School
US Department of Justice
Fish and Richardson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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