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Serving leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Johnson and Johnson
Dow
Fish and Richardson
AstraZeneca
Farmers Insurance
Federal Trade Commission
Moodys
US Department of Justice

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,119,158

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Which drugs does patent 8,119,158 protect, and when does it expire?


Patent 8,119,158 protects FENTORA and is included in one NDA. There has been one Paragraph IV challenge on Fentora.

This patent has fifty-eight patent family members in twenty-seven countries.

Summary for Patent: 8,119,158

Title:Effervescent oral fentanyl dosage form and methods of administering fentanyl
Abstract: Fentanyl-containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than known oral formulation and have advantages in terms of reduced cost and reduced side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
Inventor(s): Moe; Derek (Maple Grove, MN), Agarwal; Vikas (Plymouth, MN), Habib; Walib (Crystal, MN)
Assignee: Cephalon, Inc. (Frazer, PA)
Application Number:12/955,346
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Delivery; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYesYes► Subscribe► Subscribe► SubscribeY
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 8,119,158

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
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► Subscribe
8,092,832Generally linear effervescent oral fentanyl dosage form and methods of administering► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
7,862,833Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
7,862,832Generally linear effervescent oral fentanyl dosage form and methods of administering► 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: 8,119,158

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina047999► Subscribe
Argentina048000► Subscribe
Argentina048029► Subscribe
Argentina098347► Subscribe
Austria498395► Subscribe
Austria500821► Subscribe
Australia2004311879► Subscribe
Australia2004311880► Subscribe
BrazilPI0418213► Subscribe
BrazilPI0418228► 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 leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Julphar
US Army
Fuji
Medtronic
Covington
Teva
Mallinckrodt
Novartis

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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