Reckitt Negotiating Details For Generic Mucinex It Will Provide Mutual
Litigation over supply agreement stayed after firms indicated to US district court they would settle. Mutual showed that RB failed to honor an agreement to supply generics of the original Mucinex guaifenesin, but had not provided sufficient detail for RB to provide a product that would meet regulatory standards.
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US federal court judge says Mucinex marketer Reckitt Benckiser is not responsible for OTC private label competitor Aurobindo’s attorney fees because its patent infringement complaint was not “exceptional” and its argument had merit. The decision could bolster drug firms' confidence in defending their patents.
Mutual Pharmaceutical alleges in an antitrust suit that RB attempts to monopolize the extended-release guaifenesin OTC category with its Mucinex product. The suit says Mutual has lost “tens of millions” due to RB's failure to honor a contract to supply an “authorized generic” of the product.
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.