Article

Several secular forces are on a collision course to produce a perfect storm in the topical analgesic patch category.  Severe turbulence may develop within the coming months forcing retrenchment in how consumers choose to treat pain.  Companies with substantial revenue dependence on these product forms [patches, tapes, sleeves, bandages, pads], or who lack already approved forms in their line up will be most at risk, including Chattem [www.icyhot.com], J&J [www.bengay.com], and Mentholatum [ www.wellpatch.com].

In the 1990’s several manufacturers discovered and adapted the Japanese practice of using disposable poultices impregnated with counterirritants to treat local pain.  The monograph governing their sale was still in a tentative form [TFM] thus allowing manufacturers to introduce them into commerce.  Because the closure of each OTC monograph is often idiosyncratic and has historically taken years manufacturers have assumed the risk of launching evermore diverse forms of non-monographed topical products into a calm sea of ambiguity.  Finally in July, 2003 after over a decade of uncertainty the FDA issued a public request for arguments why these products should be considered within the monograph, a sort of regulatory show cause order.  The OTC Trade Association [CHPA] filed a brief for the industry offering essentially a pathway for self-regulation in which manufacturers would be required to test prototypes prior to launch against agreed-to standards.  Individual manufacturers filed briefs reflecting the status quo ante.

However, a violent storm may be forming.  Here’s the long range forecast…..

1.    Topical patches and allied forms will soon either require an NDA or will need to meet monograph testing requirements to enter the market.  The FDA/GSA has listed the external analgesic monograph on its biennial Uniform Agenda more than once indicative that this monograph will finalize by Dec, 2009.
2.    The leading OTC brands are defendants in a drawn out patent infringement suit.  LecTec filed a patent infringement action in US District Court in July, 2008 against major current players [J&J (Ben Gay), Chattem (Icy Hot), Mentholatum (Wellpatch), Prince of Peace (Tiger Balm), Endo (Lidoderm)] in the topical medicated patch business alleging patent infringement of their core structure and composition claims.  LecTec further alleges that in 1999 Mentholatum and Chattem through their Japanese suppliers copied their technology after visiting them.  At the patent holder’s own request the two patents at issue have been successfully reexamined (ex parte) by the patent office greatly strengthening their validity and claims structure.  Further, on Feb 10, 2009 LecTec filed a motion seeking temporary injunctive relief barring sales and distribution of defendants’ patch products.  Defendants have until June 5 and plaintiffs until July 9, 2009 to submit briefs on that motion.  Mediation points occur in Oct, 2009 and Sept, 2010.  A jury trial is scheduled to begin in Jan, 2011.  A positive infringement outcome would mean collecting royalties on sales retrospectively from the infringement date, attorney’s fees, and result in a licensing agreement going forward.  Willfulness, alleged by the plaintiff, would treble damages.  
3.    One patch OEM manufacturer [Salonpas] already holds an approved OTC NDA.  Hisamitsu Pharmaceuticals [Salonpas] filed an OTC NDA in February, 2006 approved in February, 2008 for two methyl salicylate/menthol combination patches using a 505(b)2 process [“paper NDA”].  Clearly the FDA has a viable precedent to OTC patch approval.  If no other manufacturers have availed themselves of this pathway Salonpas could emerge as the only FDA-approved patch in the US market, or even the only patch.  They are not subject to the LecTec patent litigation.
4.    An Rx anti-inflammatory patch [Flector, Alpharma/King] launched in 2009.  Flector, the first Rx topical analgesic patch, launched in early 2009; it incorporates a potent anti-inflammatory NSAID’s [diclofenac epolamine], a relative of ibuprofen.  Together with long-standing local anesthetic patches, such as Lidoderm [Endo], these prescription patches could appeal to OTC users if the OTC market collapses through its co-pays, Rx credibility, and doctor recommendation.
5.    OTC patch safety is now on the FDA’s radar screen.  In February, 2008 a topical pain relief product [Icy Hot Heat Therapy, Chattem] was subject to a rare nationwide shelf recall of an OTC product because nearly 1,000 users alleged injuries they sustained in use, some serious.  The recall came subsequent to an FDA audit and investigation.  Although this product was regulated as a medical device, not an OTC drug, it will nevertheless add a colorable argument for increased oversight over patch products that remain for long periods in close contact with the skin.

Donald K. Riker, Ph.D.
Dr. Riker is the President & Founder, On Point Advisors, LLC, a healthcare consultancy, and Editor-in-Chief, OTC Product News dedicated to the over-the-counter healthcare industry. He is the former Vice President R&D & Chief Scientific Officer, Chattem, Inc. and Associate Director & Fellow, Personal Healthcare, Procter & Gamble. Dr. Riker is an elected member of several medical and scientific organizations, The Licensing Executive Society, and the Association of Healthcare Journalists.

Comments