Adams Respiratory Therapeutics has been hit with another patent claim challenge involving its Mucinex line as it prepares to launch line extensions for its blockbuster brand and other new products in time for the cough/cold season.

Chester, N.J. based Adams is preparing for the second time in a year to protect the market position of its brand, which generated $254 million in sales in 2006. This time the threat is from private labeler Perrigo's bid to market a generic version of single-ingredient Mucinex.

Allegan, Mich.-based Perrigo's abbreviated new drug application seeking FDA approval to manufacture and distribute guaifenesin 600 mg single-ingredient extended-release tablets challenges the validity of Adams' key patents related to the formulation of Mucinex.

"We are going to vigorously defend our market position as we have done in the past," Adams CEO Michael Valentino said Aug. 21 during the firm's fiscal 2007 fourth quarter earnings call.

Perrigo's ANDA "filing will stand on or fall on its merits," Valentino said.

Adams and United Research Labs/Mutual Pharmaceutical in March agreed to a settlement of patent infringement suits Adams filed in response to URL/Mutual's August 2006 ANDA for a generic version of the extended-release Mucinex product (¹ Also see "Adams Reinforces Mucinex Patents In Settlement Agreement With Mutual" - Pink Sheet, 26 March, 2007., p. 6).

The settlement granted Philadelphia-based URL/Mutual a non-exclusive, royalty-free license for U.S. sales of single-ingredient licensed guaifenesin products beginning in July 2012, excluding certain circumstances.

However, if Perrigo or any other firm prevails with an ANDA for a generic version of the extended-release Mucinex product before July 2012, URL/Mutual may begin selling generic Mucinex 60 days before the third party's product launch, according to the settlement.

In the event URL/Mutual does not have FDA approval at that time, it can enter into a supply agreement with Adams to buy tablets at full cost plus 10 percent royalty, the firms said in March.

Adams' net sales for the quarter fell 11 percent to $46.9 million, although retail consumption of the firm's products increased 44 percent in the April-June period, the firm says, citing Information Resources Inc. data.

Chief Operating Officer Robert Casale said Adams worked on distribution and promotion programs during the quarter to launch OTC products it announced in April, including Maximum Strength Mucinex products (² Also see "Max Strength Mucinex Sales Could Reach $70M In Debut Season – Adams" - Pink Sheet, 9 April, 2007., p. 12).

During the July-September period, its fiscal 2008 first quarter, Adams is rolling out three new 1,200 mg guaifenesin cough/cold products, as well as two Mucinex nasal spray products and two new formulations for both Children's Mucinex and Delsym cough suppressant lines.

"We already have commitments and programs to support a 20 percent display increase over last year," Casale said during the earnings call.

Adams' full-year net sales were up 39 percent to $331.6 million, helped by sales of the Children's Mucinex line it launched in August 2006 and of Delsym products, a brand it acquired in June 2006, the firm says in a same-day earnings statement (³ Also see "Adams Expands OTC Cough Market Presence With Delsym Acquisition" - Pink Sheet, 29 May, 2006., p. 5).

Children's Mucinex products generated $2.6 million in fourth-quarter and $29.2 million in full-year sales. Sales of Delsym cough liquids were at $5.4 million for the quarter after generating $652,000 during the final month of the firm's fiscal 2006 fourth quarter, and were at $48.3 million for the year, the firm says.

Adams also plans to start advertising for the new Mucinex Full Force nasal spray products it expects to be growth drivers in its fiscal 2008.

The firm says its trade customers have been receptive to the products, which it expects will become the second-leading brand behind Schering-Plough's Afrin within two years of launch.

Shelf space for Full Force would be incremental and not impact the firm's current space and promotional support for the products would be based on retailers' plans to drive sales, the firm says.

- Robert W. Mitchell (r.mitchell@elsevier.com)

Adams Faces Another Mucinex Challenge, Prepares For Product Launches

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