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Details for Patent: 5,792,477

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Patent 5,792,477 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 forty-nine patent family members in thirty-one countries.

Summary for Patent: 5,792,477

Title: Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent
Abstract:A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymeric encapsulating binder, and an active agent having limited water solubility dissolved or dispersed in a solvent. An aqueous second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are separated. The discontinuous first phase is washed with water, or an aqueous solution of water and a solvent for residual solvent in the first phase, to reduce the level of residual solvent in the microparticles to less than about 2% by weight of the microparticles. Also disclosed are a microencapsulated drug prepared by the method for preparing biodegradable, biocompatible microparticles, and a pharmaceutical composition that includes biodegradable and biocompatible microparticles in a pharmaceutically acceptable carrier.
Inventor(s): Rickey; Michael E. (Loveland, OH), Ramstack; J. Michael (Lebanon, OH), Lewis; Danny H. (Hartselle, AL), Mesens; Jean (Wechelderzande, BE)
Assignee: Alkermes Controlled Therapeutics, Inc. II (Cambridge, MA) Janssen Pharmaceutica (BE)
Application Number:08/850,679
Patent Claim Types:
see list of patent claims
Process; Composition; Formulation; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 21st percentile
Forward Citations: 22nd percentile

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, 2006RXYes5,792,477► subscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007RXNo5,792,477*PED► subscribeY
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-001Oct 29, 2003RXYes5,792,477*PED► subscribeY
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Non-Orange Book Patents for Patent: 5,792,477

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
6,403,114 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► subscribe
5,916,598 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► subscribe
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► 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: 5,792,477

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina012820► subscribe
Argentina046034► subscribe
Austria223206► 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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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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