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Details for Patent: 8,728,441

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Patent 8,728,441 protects FENTORA and is included in one NDA. There has been one Paragraph IV challenge on Fentora.

This patent has thirty-two patent family members in twelve countries.

Summary for Patent: 8,728,441

Title:Sublingual buccal effervescent
Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administrable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.
Inventor(s): Eichman; Jonathan D. (Ann Arbor, MI), Hontz; John (Plymouth, MN), Khankari; Rajendra K. (Maple Grove, MN), Pather; Sathasivan Indiran (Plymouth, MN), Robinson; Joseph R. (Madison, WI)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:13/098,986
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 0th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-001Sep 25, 2006RXNo8,728,441► subscribe MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXNo8,728,441► subscribe MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYes8,728,441► subscribe MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL ADMINISTRATION OF FENTANYL
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Non-Orange Book Patents for Patent: 8,728,441

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
6,200,604 Sublingual buccal effervescent► subscribe
8,802,130Sublingual buccal effervescent► subscribe
6,764,696 Effervescent drug delivery system for oral administration► 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: 8,728,441

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Portugal1419765► subscribe
Portugal1417959► subscribe
Portugal1082106► 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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