Tuesday, July 23, 2013

Cephalon, Impax Settle Suit over Fentora Generic

On Nov 2011, a suit was filed by Cephalon (which was later acquired by Teva) and CIMA Labs against Impax, alleging infringement of four patents for the drug Fentora, used to treat pain associated with cancer. The patents in suit were:

Patent Number
Current Assignee[i]
Issued Date
Expiration Date[ii]
Mar 13, 2001
Mar 26, 2019
Sublingual buccal effervescent
Dec 13, 2005
Mar 26, 2019
Sublingual buccal effervescent
Jan 04, 2011
Dec 30, 2024
Generally linear effervescent oral fentanyl dosage form and methods of administering
Jan 04, 2011
Dec 30, 2024
Effervescent oral opiate dosage forms and methods of administering opiates
Source: MaxVal’s Assignment Database

According to the complaint, Impax filed an Abbreviated New Drug Application (ANDA) no. 203357 with the FDA to market a generic version of Fentora (fentanyl buccal tablets) containing 100, 200, 400, 600, and 800 meg of fentanyl citrate in violation of the above patent protections. Cephalon is the current holder[iii] of approvals for the drug Fentora (source: Patent Marker) with New Drug Application (NDA) no.  021947 approved by FDA on Sep 25, 2006. The complaint sought judgment of infringement, damages and permanent injunction to stop Impax’s generic sales.

The parties have announced to Court that they have settled the case and reached an agreement that is effective from Jun 21, 2013. As part of the agreement, the parties agreed to dismiss the case. Upon consideration the Court rendered its final verdict, ordering: 

  • Dismissal with prejudice
  • Parties to bear their own costs and expenses
  • Patents-in-suit are valid and enforceable
  • Impax is enjoined from manufacturing/ marketing generic version of Fentora until specified in the agreement

Case Details:

Court: Delaware District Court

Case Filed: Nov 18, 2011

Case Closed: Jul 16, 2013

See case 1:11-cv-01152 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts

Are you looking for a tool to calculate patent terms? Try Patent Term Estimator, our free tool or download our free Android app on Google Play Store.  

[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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