Perrigo will launch private-label equivalents of OTC heartburn reliever Zantac 150 this summer.

Though other generics of Boehringer Ingelheim's H2 antagonist beat Perrigo to the punch, FDA's approval of the private labeler's abbreviated new drug application marks the first such approval from the firm's Allegan, Mich., plant since it resolved an FDA warning letter in April.

In a May 16 release, Perrigo said it received the ANDA approval May 11 and will launch the products early in the firm's fiscal 2012, which begins in late June.

Indian generics companies Dr. Reddy's Laboratories and Wockhardt both received the go-ahead for generic OTC Zantac 150 (ranitidine 150 mg) in 2007 ("Dr. Reddy's wins generic Zantac approval," "The Tan Sheet" Sept. 24, 2007, In Brief).

In addition to the regular tablets already available private label, Perrigo will offer the first generic of cool mint-flavored Zantac 150.

Perrigo's ANDA approval is an encouraging sign for its Allegan facility, where all applications were on hold for nearly a year as the company corrected quality control issues cited by FDA in an April 30, 2010, warning letter (Also see "Perrigo Takes Two Steps Forward: Generic Allegra Launch, Manufacturing Compliance" - Pink Sheet, 18 April, 2011.).

Other recent OTC approvals for Perrigo did not originate at Allegan; its generic version of Sanofi's Allegra is licensed from Teva Pharmaceutical Industries.

Perrigo's ANDA for an equivalent to Johnson & Johnson's Men's Rogaine Foam, approved April 28, originated at the company's Israeli subsidiary (Also see "Perrigo Rogaine Foam ANDA May Help Extend Record Growth" - Pink Sheet, 9 May, 2011.).

Analysts See "Incremental Positive"

Through Perrigo's relationships with retailers and comprehensive marketing and education programs, the firm typically expects to become the generic leader for most products it launches, even when not first to market.

Perrigo's products could take 50% to 55% of the store- brand ranitidine 150 mg segment, which in turn is expected to claim as much as 30% of the branded Zantac 150 business, according to a UBS research note. Perrigo estimates Zantac 150 sales at $110 million annually.

The UBS analysts call the Zantac 150 generic approval "an incremental positive" for Perrigo and forecast the product will bring in between $7 million and $13 million, or 2 to 3 cents of earnings-per-share contribution.

Collins Stewart analyst Louise Chen predicts Zantac 150 and other OTC launches planned for fiscal 2012, including equivalents to Mucinex, Zegerid OTC and Delsym, will continue helping drive Perrigo's growth.

Still, Chen projects the private labeler to slow down in the coming fiscal year. Revenue for 2011 is estimated at $2.73 billion, up 20.1% over the prior year, while revenue in 2012 is projected to climb 10.6% to $3.02 billion, according to a May 16 research note.

By Dan Schiff

Perrigo's Zantac 150 Generic Marks First Approval From Remediated Plant

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