Ranbaxy Pharmaceuticals Inc, a wholly owned US subsidiary of Ranbaxy Laboratories Ltd, India's largest pharmaceutical company, today announced that it has received a tentative approval from the USFDA to market lisinopril and hydrochlorothiazide tablets, 10/12.5 mg, 20/12.5 mg and 20/25 mg.
The tablets are indicated for the treatment of hypertension and are a generic copy of Merck's Prinzide anti-hypertension drug.
The tentative approval comes close on the heels of the okay received by the company for lisinopril tablets as a single entity in October 2001. Lisinopril is the generic name for Astra Zeneca's hypertension drug Zestril. "Based on this tentative approval, all strengths of this combination prouct will be available along with lisinopril as a single entity formulation. Ranbaxy will be one of the few companies that will have the approval for both the single entity and the combination product of lisinopril," a Ranbaxy release issued here today said.
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With both the approvals in hand, RPI will be prepared to launch these products at the conclusion of the pediatric exclusivity that expires on June 29, 2002. At that time, RPI plans to make it available in the US market. "It is anticipated that the market will be highly competitive, however, few generic companies are anticipated to offer both formulations simultaneously," the Ranbaxy release said.
The lisinopril market in the US totaled sales of $1.2 billion during 2000. Of this, while the single entity accounted for $1 billion, the combination product clocked sales of $277 million.
Commenting on the occasion, Ranbaxy Laboratories president Brian Tempest said: "We are most satisfied with the rapid approval for both of our abbreviated new drug application (ANDA) filings and will now take the necessary steps to be in a state of readiness at the time of the expiry of the pediatric exclusivity. This will further maximise the value of these ANDAs to our organisation and provide value to the US healthcare system." The approval for the product has come within 14 months of the ANDA being filed by RPI.