Monday, December 10, 2012

Medicis Sues Alkem over Generic Version of Solodyn

Medicis (plaintiff) filed a complaint against Alkem, The Pharma Network and Ascend (defendants) in the U.S. District Court of Delaware (case no. 1:12-cv-01663) on Wednesday, December 05, 2012, for filing ANDA for generic version of Solodyn®

Medicis Pharmaceutical Corporation is a specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. Their products include Solodyn and Ziana for treating acne. Alkem is in the business of manufacturing generic pharmaceutical drugs. The Pharma Network (TPN) is a wholly owned subsidiary of Alkem. Ascend markets pharmaceutical products including generic drugs manufactured by Alkem. 

The patents involved in this suit are

Patent Number
Current Assignee[i]
Issued Date
Expiration Date[ii]

Jun 01, 1999
Feb 19, 2018
Method for the treatment of acne

Sep 07, 2010
Jun 24, 2025
Minocycline oral dosage forms for the treatment of acne

Sep 18, 2012
Jun 24, 2025
Minocycline oral dosage forms for the treatment of acne
Note: Table information sourced from Maxval’s Assignment Database and Litigation Database.

Medicis is the current holder[iii] of the New Drug Application (NDA) no. 050808 for Solodyn® (source: Maxval’s Patent Marker) that is approved by FDA. Solodyn® is a tetracycline antibiotic approved to treat pimples and red bumps occurring with moderate to severe acne in people above 12 years. The complaint is filed against the defendants for seeking FDA approval with the Abbreviated New Drug Application (ANDA) no. 204453 (the Alkem ANDA) to market a generic version of Solodyn® that infringes the above patents.  

Plaintiff has recently filed suit against the companies below:

Case Number
Date Filed
If you are interested in knowing more about the cases filed by Medicis, please contact us.

For more details, visit MaxVal-IP and subscribe to our Litigation Alerts.

[i]MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[ii]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.
[iii]Patent Marker provides an online environment for patentees to virtually mark products and search for patent related information.

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