Dr Reddy's Laboratories on Monday announced that it had received final approval from the United States Food and Drug Administration for the company's new drug application for amlodipine maleate, under AmVaz brand name.

Dr Reddy's is the first Indian pharma company to receive FDA approval for a NDA under Section 505 (b) (2) of the Federal Food, Drug and Cosmetics (FFDC) Act, which allows a company to market its product if the new drug is a slight modification of the innovator's original product, or a new dosage form, or for a new indication.

Dr Reddy's AmVaz (amlodipine maleate) is slightly different from Pfizer's Amlodipine Besylate through a change in salt composition. Amlodipine Besylate, the generic version of Pfizer's $2 billion product Norvasc, is indicated for the treatment of hypertension and angina. The company's share rose 9.75 per cent -- or by Rs 117 -- on Monday to close at Rs 1,312 on the National Stock Exchange on Monday.

Commenting on the development, G V Prasad, the CEO of Dr Reddy's, said, "The final approval marks a significant milestone for Dr Reddy's, setting the stage for the launch of our first specialty branded product in the United States. We have not made a final decision on the launch date. But we are making all necessary preparations for the launch and are in the process of finalising a co-promotion partner for AmVaz in the United States."

Though, technically, the FDA's final approval enables Dr Reddy's to launch the product in US, the real hitch lies in the pending judgement on Pfizer's appeal before the upper Circuit Court against the New Jersey District Court's ruling (in December 2002) dismissing its complaint on the grounds that the patent term extension does not cover Dr. Reddy's product.

Final hearing in Circuit Court was completed on July 9 and the judgement is awaited.

If Dr Reddy's prefers to launch the product without waiting for the legal outcome, it would be running the risk of paying huge damages in the event of judgement going in favour of Pfizer.

"We have not yet taken any decision on the possibility of launching the drug without waiting for the judgement. It is a risk versus benefit situation. We have kept both the options open and it will take some time before taking a final decision," K Satish Reddy, the chief operating officer of Dr Reddy's, told Business Standard.

"Final hearing was over about 4 months back. Judgement will be given in a time span of 5 to 9 months after completion of hearing in most of the cases. We also agree with the Pfizer's view, which expressed hope that the judgement would come before the end of the year," Satish Reddy added.

"We are looking for a tie-up with a speciality products company, which has a good field force, to co-promote our product in US. Our earlier tie-ups with two companies is for the marketing of generic products. AmVaz is a speciality branded product," Reddy said.

The company is also planning to launch amlodipine maleate in Europe upon expiration of the supplementary protection certificate in March 2004.

Dr Reddy's had filed NDA for amlodipine maleate in December 2001 and the FDA had in October 2002 determined the NDA as "approvable".

If company succeeds in launching the product in US, it will have a de facto exclusivity of at least 18 months in the sense that it will take that much time for any other company to complete all the regulatory formalities for the launch of the product. This is expected to give a major boost to Dr Reddy's topline and bottomline.

Dr Reddy's contention in the legal battle with Pfizer is that the patent term extensions granted to latter applies only to marketed products and does not apply to its (Dr. Reddy's) product since their molecule is an innovation on the existing molecule of Pfizer.

Dr Reddy's US product pipeline currently comprises 27 abbreviated new drug applications, 2 NDAs (including amlodipine maleate) and 44 DMFs. Of these ANDAs, 20 were submitted under Paragraph IV.

During the current fiscal, the Company expects to file 15-18 ANDAs, 15 DMFs and additional NDAs.