Mylan N.V. announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's glatiramer acetate injection 40 mg/mL, the first generic version of Copaxone 40 mg/mL. The litigation involved two non-Orange Book listed patents, US patent Nos. 9,155,775 and 9,763,993, relating to the final sterile filtration step in the manufacturing process for glatiramer acetate products.
Teva dropped litigation on these patents after the US District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims. In addition, Teva has agreed to withdraw the Irish equivalent to these patents from the recently filed proceeding in Ireland.
After the dismissals, Teva's only remaining patent challenges in the US and Ireland against Mylan's glatiramer acetate injection 40mg/mL relate to the three-times-a-week dosing regimen, which Mylan has already successfully invalidated at the US District Court for Delaware, the US Patent Trial and Appeal Board and the United Kingdom's High Court of Justice. Teva is appealing these decisions.
We are extremely proud to be the first company to offer MS patients in the US our glatiramer acetate injection 40 mg/mL as an alternative to Teva's Copaxone three-times-a-week formulation. The ruling and case dismissal give us even greater confidence in our ability to continue providing this important product to thousands of MS patients nationwide who are living with this very difficult disease and in need of a more affordable treatment option.
In early October, Mylan received FDA approval and launched its glatiramer acetate injection 40 mg/mL for three-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL. According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application for glatiramer acetate injection, 40 mg/mL, containing a Paragraph IV certification.
Copaxone is the most prescribed MS treatment for relapsing forms of MS in the US with brand sales for the 20 mg/mL dose of approximately $667 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending October 31, 2017, according to IQVIA. Approximately 400,000 individuals in the US have MS and relapsing MS accounts for 85% of initial MS diagnoses.