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Details for Patent: 8,603,514

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Patent 8,603,514 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: 8,603,514

Title:Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Abstract: The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.
Inventor(s): Yang; Robert K. (Fushing, NY), Fuisz; Richard C. (McLean, VA), Myers; Garry L. (Kingsport, TN), Fuisz; Joseph M. (Washington, DC)
Assignee: MonoSol RX, LLC (Warren, NJ)
Application Number:11/775,484
Patent Claim Types:
see list of patent claims
Composition; Delivery; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Medical technology
Back Citations: 0th percentile
Forward Citations: 3rd 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, 2010RXNo8,603,514► subscribeY TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-003Aug 10, 2012RXNo8,603,514► subscribeY TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior Inc
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL022410-002Aug 30, 2010RXNo8,603,514► subscribeY TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
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Non-Orange Book Patents for Patent: 8,603,514

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: 8,603,514

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria536868► subscribe
Austria536869► subscribe
Austria553746► 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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