Austedo, Teva’s tardive dyskinesia (TD) therapy, has great prospects. Now the company only needs to worry about one less generic pharmaceutical presenting a threat to its main growth engine.Teva announced recently that it had reached an agreement with Lupin that will enable the Mumbai-based generics company to sell its formulation of Austedo in the United States beginning in April 2033. Teva filed separate lawsuits in federal court in New Jersey in July, suing Lupin and yet another Indian pharmaceutical major, Aurobindo, for their proposed generic versions.
Teva had been alerted by both companies that they aimed to file abbreviated new drug applications (ANDAs) with the FDA. Teva listed multiple Austedo patients in both lawsuits. Teva said the lawsuit with Aurobindo, located at Hyderabad, is still pending. Teva claimed it had sought unsuccessfully to evaluate both generic companies’ FDA files when it submitted the complaints last year. Meanwhile, the US Patent Office’s Patent Trial and Appeal Board denied Apotex’s petition to challenge Teva’s compound patent on the medication two months ago.
Austedo was approved by the FDA in 2017 as the first medication to cure both TD and chorea in Huntington’s disease patients. Involuntary jerky movements, mainly in the shoulders, hips, and face, are indications of TD and chorea. Antipsychotic medications, such as those used to treat schizophrenia and bipolar illness, can cause TD.
Teva is banking on revenue growth from Austedo and Ajovy, a migraine preventive medicine, as other sections of the company struggle with pricing challenges. Austedo made $802 million in revenue in 2021, up 26 percent from the previous year.
