Cary, N.C. - What has been common practice in the pharmaceutical industry for years is about to debut in the pesticide industry – product labeling that includes a statement identifying the branded version of the generic alternative. The EPA Office of General Counsel recently granted a request from post-patent supplier Gro-Pro LLC to use the statement on its product labels, marking the first time this type of language has been approved for pesticide product labels.
On all product labels moving forward, Gro-Pro will include a statement saying “Contains [name of active ingredient], the active ingredient used in [brand name or trademark].” Such language is routinely included on the labels of generic drug products.
“As patents on widely used products continue to expire, it’s important to begin to educate the market about post-patent alternatives,” according to Randy Canady, vice president of marketing and business development.
“Our products are registered as ‘me-too’ products [or generic alternatives],” Canady says. “To be registered, they must meet the regulatory standard established under FIFRA to qualify as a generic product, i.e., that our version is ‘substantially similar or identical’ to the branded version.”
According to the Federal Insecticide, Fungicide and Rodenticide Act, a product is identical or substantially similar to a branded product if it would be identical or substantially similar in composition and labeling to a currently-registered pesticide; or if it would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
Gro-Pro’s recently registered SFM G-Pro 75 EG, T-Methyl G-Pro 4.5 F, and T-Methyl G-Pro 50 WSB are the first product labels impacted by this ruling, although the company will revise all labels to include the statement.
Gro-Pro LLC focuses exclusively on the non-crop, specialty markets. The Florida-based company also operates an office in the Research Triangle Park area of North Carolina. Gro-Pro offers post-patent pesticide products for turf and ornamental, pest control and vegetation management and forestry.
