Patent Fight between Teva Vs Glenmark For Cardiac Drug, Carvedilol

Indian Drug maker Glenmark has  challenged the monopoly of global generic giant Teva Pharmaceutical Industries Ltd for the cardiac drug carvedilol  which has a sell of around $2 billion in US market, by  filing its counterclaims in the US district court of New Jersey, claiming Teva’s two patents for making the drug is invalid and unenforceable.

Carvedilol was originally patented by GlaxoSmithKline Plc. which is widely used for treating congestive heart failure, under the brand name Coreg.

The product patent on this drug has expired in 2007, the generic companies including three Indian firms—Dr Reddy’s Laboratories Ltd, USV Ltd and Glenmark—have got approvals for copies of Coreg from the US Food and Drug Administration (FDA).

Teva had patented two different processes of making the active pharma ingredient (API) of this drug, and blocked most of the other generic manufacturers from entering the market on the strength of this.

Teva sued all the generic companies who have received the FDA approval for the drug and most of them settled the case with Teva and some of them even agreed to supply the API to Teva exclusively.

Glenmark, which is fighting a patent infringement case on carvedilol filed by Teva in August, has accused the Israeli drug firm of engaging in fake litigations and violating anti-trust law. But Teva believes that its patents are valid and Glenmark infringes those patents,”

Though the product patent has expired in US, the market price has not come down significantly in the absence of competition. While Glaxo sells the product at $246 for 100 tablets, Teva’s price is $213.

According to source “Teva is trying to monopolized the market for carvedilol API by enforcing a patent which is invalid and prosecuting generic manufacturers that do not purchase carvedilol API from Teva in order to secure contracts with those companies,”

 

According to an executive of an Indian drug marker involved in a similar case in the US, if there is a ruling in favour of Glenmark, “it will certainly trigger an anti trust investigation against Teva’s share in this generic cardiovascular drug market.”