Welcome back to The Pharmaceutical News, today kicks of another run of World Generic Markets articles, kindy provided by Ian Platts editor of the World Generic Markets business publication.
Watson Pharmaceuticals announced a round of product approvals and litigation over a few days in June 2011, as well as an NDA from a partner company being accepted for filing by the FDA. On 17th June, Watson Laboratories gained approval from the FDA for its 500 mg and 750 mg nabumetone tablets. The product is a generic equivalent of GlaxoSmithKline’s discontinued product, Relafen. Watson is the ninth generic competitor for the product, with the other eight manufacturers being Teva Pharmaceutical Industries, Sandoz, Par Pharmaceutical Companies, InvaGen Pharmaceuticals, Dr Reddy’s Laboratories, Actavis Elizabeth, Matrix Laboratories and Lupin. Teva was the first to gain approval, with its 500 mg version gaining approval in May 2000, and its 750 mg version in June 2000; as GlaxoSmithKline has discontinued its version, Teva’s was the reference listed drug. Ten days later, Watson reported that its partner, Columbia Laboratories’, NDA for Prochieve, a proprietary progesterone gel for the reduction of risk of preterm birth, had been accepted for filing by the FDA, triggering a US$5 million milestone payment from Watson to Columbia. Watson’s collaboration with Columbia regarding Prochieve goes back to March 2010, when Watson announced an agreement to expand its Women’s Health brand product portfolio with the acquisition of the exclusive US rights to Columbia’s two bioadhesive progesterone gel products, Crinone and Prochieve. At the time of the announcement, Watson added that the two firms would collaborate in the ongoing Phase III development programme aimed at gaining a new indication for the two products for the prevention of preterm birth in women with a short cervix.
On the same day that Watson gained its nabumetone tablets approval, the firm also reported that the US District of Nevada had denied Duramed Pharmaceuticals’ (now part of Teva Pharmaceutical Industries) request for a preliminary injunction and request for a temporary restraining order preventing Watson’s launch of its version of Seasonique, a Duramed oral contraceptive. Watson had gained approval from the FDA for its version in May 2011, but the litigation had centred on one of four patents listed in the FDA’s Orange Book. Interestingly, the FDA had noted that the four patents were not listed in the Orange Book at the time Watson filed its ANDA, but were added afterwards, leading Watson to amend its application to include Paragraph IV certifications for each patent. As a result, the FDA decided that the 30-month stay of approval mandated under the Hatch-Waxman Act would not apply; however, the agency also added that the 180-days marketing exclusivity that Watson would normally have been eligible for would also not apply. Watson subsequently launched its version on 28th July 2011.
Three days later, on 20th June, Watson confirmed that it had initiated a patent challenge, for GlaxoSmithKline’s Avodart (dutasteride) capsules. GlaxoSmithKline responded to the filing of the ANDA with a lawsuit in the US District Court for the District of Delaware, which was filed under the provisions of the Hatch-Waxman Act, with the result that the FDA will be prevented from approving Watson’s version until 17th November 2013, unless the court finds in the generic firm’s favour earlier. To date, one generic version of Avodart has been approved. The ANDA, filed by Teva Pharmaceutical Industries, had also led to patent infringement litigation, but the FDA noted that this was dismissed by agreement of the parties.
Finally, on 22nd June, Watson reported that it was expanding its Salt Lake City pharmaceutical research, development and manufacturing site. The expansion, costing some US$44 million, is at the firm’s plant for transdermal patches and topical gels, and could ultimately result in 300 new jobs being created and a potential tripling of annual production capacity. Overall, some 200 people are already employed at the site. The expansion should come in time for a generic version of Teikoku Pharma’s Lidoderm (lidocaine) topical patch to be approved; Watson hopes its version will gain FDA approval in 2012.