Generic News: New Approvals and New Research

Lupin has launched its generic version of Spiriva HandiHaler. Lupin’s tiotropium bromide inhalation powder capsule is approved to treat patients with chronic obstructive pulmonary disease (COPD).

Additionally, the FDA has approved several generic products developed by Lupin. Pitavastatin tablets, 1 mg, 2 mg, and 4 mg and a generic equivalent of Livalo, was approved to treat adults with primary hyperlipidemia, and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.

Lupin has also received tentative approval from the FDA for dapagliflozin tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga, which is used to treat patients with diabetes. Both products will be manufactured at Lupin’s Pithampur facility in India.

Lupin also received FDA approval of ganirelix acetate injection, 250 mcg/0.5 mL single-dose prefilled syringe, which is used for infertility treatment. It will be manufactured at Lupin’s Nagpur facility in India.

In other generic news:

• The FDA has approved Teva Pharmaceutical’s generic version of Forteo (teriparatide), which is used to treat patients with osteoporosis. Teva’s generic uses the Antares Pharma multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics and Teva have a development and supply agreement for teriparatide auto injector product that Teva markets currently markets in the European Union and will market in the United States. Teva’s generic teriparatide is expected to be available in the coming weeks.
• The FDA has approved Ani Pharmaceuticals’ 1-mL vial of purified cortrophin gel. Cortrophin gel is also available in a 5-mL vial. It is indicated for short-term administration as an adjunctive therapy during an acute episode or exacerbation in acute gouty arthritis.
• Amneal is developing to two denosumab biosimilars that referencing both Prolia and Xgeva. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated to treat patients with bone metastasis from various forms of cancer, as well as for the prevention of bone pain and fractures, including osteoporosis-related injuries. The two denosumab products are being developed by mAbxience. Amneal will move the products through regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience also currently partner on Alymsys, a bevacizumab biosimilar.
• Apotex has launched teriparatide Injection, a single-patient-use pre-filled pen used for the treatment of osteoporosis. Teriparatide Injection is supplied as a single-patient-use pre-filled pen containing 250 mcg/mL, capable of administering 28 daily doses of 20 mcg per pen.