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Details for Patent: 8,017,150

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Patent 8,017,150 protects SUBOXONE and is included in one NDA. There have been three Paragraph IV challenges on Suboxone.

This patent has one hundred and one patent family members in thirteen countries.

Summary for Patent: 8,017,150

Title:Polyethylene oxide-based films and drug delivery systems made therefrom
Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.
Inventor(s): Yang; Robert K. (Flushing, NY), Fuisz; Richard C. (McLean, VA), Myers; Garry L. (Kingsport, TN), Fuisz; Joseph M. (Washington, DC)
Assignee: MonoSol Rx, LLC (Portage, IN)
Application Number:12/107,389
Patent Claim Types:
see list of patent claims
Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 161st percentile
Forward Citations: 15th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-001Aug 30, 2010RXNo8,017,150► subscribeY
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXNo8,017,150► subscribeY
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXNo8,017,150► subscribeY
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Non-Orange Book Patents for Patent: 8,017,150

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
7,897,080Polyethylene-oxide based films and drug delivery systems made therefrom► subscribe
7,357,891Process for making an ingestible film► subscribe
8,906,277Process for manufacturing a resulting pharmaceutical film► 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: 8,017,150

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2011068689► subscribe
Japan5723601► subscribe
Japan2011093936► 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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