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ALLEGAN, Mich. — Perrigo Co. said its partner Teva Pharmaceutical Industries Ltd. has begun shipping triamcinolone acetonide nasal spray.
The product is the AB-rated equivalent to Sanofi’s Nasacort AQ, according to Perrigo. The medication is indicated for the treatment of the nasal symptoms of seasonal and year-round allergies in adults and children ages 6 and older.
Perrigo said Wednesday that Teva (previously Barr Laboratories Inc.) was the first applicant to file a complete abbreviated new drug application (ANDA) with a Paragraph IV certification for Nasacort AQ and is launching the product with 180 days of generic exclusivity. The Hatch Waxman litigation between Teva and Sanofi was settled in 2008.
The product was developed and will be manufactured at Perrigo, which said it will share in the costs and benefits in Teva’s marketing of the products under the agreement.
Sales of Nasacort AQ totaled about $226 million for the 12 months ended in May, according to Wolters Kluwer data cited by Perrigo.
"The launch of triamcinolone nasal spray is a terrific example of Perrigo’s strategic focus on developing challenging products in the extended topical categories," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "It further demonstrates our strategy to deliver quality, affordable health care for generic prescriptions and over-the-counter products."
