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More Frontline Plus Generics to Exit Market Due to Patent Issues

Posted: July 21, 2011, 7:45 p.m., EDT


In a move that will apparently remove most Frontline Plus generics (fipronil-methoprene combinations) from the market, Sergeant’s Pet Care Products Inc. of Omaha, Neb., plans to voluntarily remove its various products, citing patent infringement.In a move that will apparently remove most Frontline Plus generics (fipronil-methoprene combinations) from the market, Sergeant’s Pet Care Products Inc. of Omaha, Neb., plans to voluntarily remove its various products, citing patent infringement.

Sergeant’s is initiating a return and exchange of all fipronil-methoprene products sold in a broad range of channels, including those sold as FiproGuard Plus (pet specialty retail), Pronyl OTC Plus (mass market retail), EctoAdvance (veterinary channel via Meridian Animal Health), Spectra Sure (direct to consumer via Durvet) and Prefurred (professional pest control market) because they infringe Merial's U.S. patent 6,096,329.

Sergeant’s has not yet disclosed specifics of the return and exchange program or its future plans for marketing flea and tick control products combined insecticides with insect growth regulators (IGR).

Fipronil-based generics not containing methoprene will remain on the market. The inclusion of the IGR is designed to help prevent reinfestation of the pet by killing pests at the egg and larva stage, not just the adult fleas and ticks that Fipronil kills.

The action follows a continuing legal battle between Merial and Cipla and Velcera regarding patent claims surrounding their fipronil and methoprene flea-and-tick control products.  In June, a U.S. District Court for the Middle District of Georgia ruled that sales of PetArmor Plus manufactured by Cipla Ltd. and Velcera Inc. infringed on Merial’s patents covering its flea-and-tick product FrontlinePlus. Cipla and Velcera officials say they will appeal the verdict and an order to remove the products from the market was stayed 60 days pending the appeal.

In January, Sergeant’s announced an agreement with Japanese company Sumitomo Chemical Co. Ltd. for the licensing of Sumitomo’s patent U.S. 5,567,429 in association with the development, manufacture and sale of a composition combining fipronil with an insect growth regulator to eliminate and prevent pests on dogs and cats.

The January announcement said the license would permit Sergeant’s to utilize the patent in the manufacture and sale of spot-on pesticidal compositions that combine fipronil with an insect growth regulator such as methoprene or pyriproxyfen.

Sergeant’s then launched Fiproguard Plus and Pronyl OTC Plus (as well as base versions with just fipronil) at Global Pet Expo in Orlando in March.

The Sumitomo patent covers the combination of an IGR with a fipronil-class insecticide to control a wide variety of pests, including both "sanitary pests (e.g. flies, mosquitoes, cockroaches and mites), and blood-sucking pests such as ticks, fleas, etc. which are parasites on animals (e.g. pets).” The patent also claims effectiveness against ants, crickets, hornets, aphids, stink bugs, beetles, weevils, butterflys, spiders, millipedes and silverfish. However, the Sumitomo patent does not refer to a spot-on delivery system, but discusses, in the case of pet use, a pest-controlling collar with the caveat that "the present invention is not to be interpreted as being limited to these examples only.”

By contrast, the Merial patent emphasizes the use of fipronil as the most likely insecticide, the use of it to control fleas on cats and dogs, and the delivery of it in a spot-on type formulation.

Meanwhile, Merial this week launched its newest flea and tick product for dogs, Certifect, at the American Veterinary Medical Association convention in St. Louis.

Certifect essentially combines Frontline Plus with a small amount of amitraz, another pesticide effective against ticks, that results in a faster killing of ticks (begins within 6 hours and can kills all ticks within 18 hours, according to Merial) and, unlike other pesticides, the detachment of the ticks before they die. Both the quicker kill and the detachment help prevent the spread of disease to dogs from the ticks, according to Mike Murray, DVM, technical marketing director for Merial.

Apparently the combination of amitraz and fipronil have a synergistic effect that makes the compound more effective than either compound alone, Dr. Murray said.
 
He said that Certifect is not designed to replace Frontline Plus and emphasized that flea and tick control is really about disease control, not pest control, and that pet owners should consult their veterinarian for the proper product for their situation (including an assessment of existing tick risks).

Also, because Amitraz is a monamine oxidase inhibitor, people taking MAOI-containing medications (including certain antidepressants that can also be used to treat Parkinson’s and social anxiety and prevent migraines) should be especially cautious when handling the product.

Certifect will be more expensive than Frontline Plus and is not for use of cats, although safety studies in Europe did not indicate adverse effects on cats in homes with treated dogs.

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More Frontline Plus Generics to Exit Market Due to Patent Issues

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I am glad to see some of the generic Frontline products removed from the market. The EPA did not require those products to be tested for safety or effectiveness. Instead, it allowed the manufacturers of those products to cite data that had been submitted by Merial years ago for its Frontline products.

If flea and tick control is really about disease control, as Merial's marketing director stated, then pet pesticides such as Frontline and Certifect should be regulated by the FDA, which has much higher standards for safety and effectiveness than the EPA. The fact is, those products cannot prevent the transmission of tick-borne diseases.

What would happen if Certifect were accidentally applied to a cat, or if a cat were to come into close physical contact with a treated dog and ingest the product? What would happen if a child were to pet a dog treated with Certifect and then put their fingers in their mouth?

It sure sounds like Certifect is more dangerous to cats and children with no guarantee of disease prevention.
hamishdad, Philadelphia, PA
Posted: 7/22/2011 4:39:42 AM
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