Wockhardt USA LLC expects to change the shape of the over-the-counter private label market by providing products directly to retailers, beginning with fexofenandine caplets that more closely resemble the size and shape of the Allegra Allergy brand than other generics.

The Wockhardt Ltd. subsidiary on Dec. 30 announced its 60mg and 180mg fexofenandine antihistamine products are available for retailers to use as their store brand selections. Wockhardt USA, which already makes generic OTCs in contract manufacturing for other drug firms, expects to begin shipping the fexofenandine products to retailers in June 2015.

“That’s good timing for retailers because of their fall allergy advertising schedule,” said Phil Tucker, the firm’s senior director for OTC business.

While Perrigo Co. PLC and Dr. Reddy's Laboratories Ltd already provide generic equivalent formulations of Sanofi’s Allegra Allergy, Wockhardt USA’s products also are equivalent to the brand’s color, size and shape, Tucker said in an interview.

Wockhardt emphasizes the equivalence to the brand’s color, size and shape in its fexofenadine products to retailers, he said.

“Retailers want their products to be as close as possible to the national brand,” he said.

Wockhardt USA’s fexofenadine products are equivalent to Allegra Allergy’s color, size and shape in addition to being equivalent formulations.

Image courtesy of Wockhardt USA LLC

And FDA also is concerned whether generics, both OTC and Rx drugs, are similar in appearance to the brands, Tucker added, noting the agency’s December 2013 draft guidance, “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.”

In the draft, FDA’s Center for Drug Evaluation and Research said “generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug,” but CDER is “concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.”

“We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates,” according to the draft guidance.

CDER explained in the draft that the guidance does not apply to approved generic drugs already on the market, but said if FDA “determines that an approved product should be modified because the size or shape of a product poses a risk to public health, we will notify the holder of the” abbreviated new drug application for the product.

“FDA eventually will publish a final guidance on that,” Tucker said.

Brand And Formula Equivalent

Tucker moved to Wockhardt USA in late 2013 after 20 years with Perrigo, most recently working in new product and business development. He said “from day one” in his career, he emphasized “inviting comparison to the national branded product” for a generic product.

From left, the branded product, Sanofi’s Allegra Allergy, and the generics: Wockhardt USA’s, Perrigo’s and Dr. Reddy’s.

Image courtesy of Wockhardt USA LLC

Particularly when a branded drug is a relatively large tablet, such as Allegra Allergy, consumers want a similarly sized generic, he said.

“If the consumer has been using Allegra and they try the store brand and find it harder to swallow, they may not re-purchase the store brand.”

Parsippany, N.J.-based Wockhardt USA notes polling data from Harris Interactive, 40 percent of the adult population has trouble swallowing pills and approximately twice as many women as men have trouble taking pills.

FDA’s draft guidance on physical attributes of generics points out the Harris data show less than a quarter of consumers who experience difficulty swallowing medication discuss the problem with a health care professional and 4% have discontinued use of a drug. “Individuals who find it difficult to swallow tablets and capsules frequently blame the size,” CDER said in the draft.

Expanding Existing Retail Relationships

Wockhardt USA already is the source of some generic OTCs available in the U.S. through contract manufacturing for other private label firms, but now it is offering to provide the products directly to retailers.

Tucker said while Wockhardt USA has not determined whether it will continue contract manufacturing OTCs, the firm is sure of its outlook in the private label market. As a leading provider of Rx generics to retailers, Wockhardt USA already has relationships with the target market for its OTC generics.

“This is an opportunity for another provider to enter the market. We see it as an opportunity to vertically integrate and go directly to the retailer. We also can do the packaging,” Tucker said.

Wockhardt USA will offer to provide “any unmet need” in the generic OTC space, he added. “Whether it’s a consumer need or a retailer need, we are going to go after those.”

[Editor's note: Each week, "The Pink Sheet" DAILY features a story from "The Tan Sheet," highlighting a current topic in the consumer medicines or nutritional supplements sectors.]

Wockhardt Shapes Its Entry Into Private Label OTCs With Allegra Allergy Generic

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