Ranbaxy Pharmaceuticals Inc, which has secured an approval from the US FDA to market the generic version of Augmentin in the highly profitable US market, has not yet decided to launch the product. To launch or not to launch is the question now, though industry sources say it is too big a product to be ignored.
Though RLL, the Indian parent of RPI, has enough reason to be jubilant over the approval, the very fact that GSK has slammed suits on Geneva Pharmaceuticals Inc, an afflilitate of Novartis AG, and Biochemie -- in its bid to protect its eroding Augmentin business, it appears that RLL would prefer to wait and watch before jumping into the fray. The launch may not happen even in the first half of the next year.
A top RLL official looking after the international business of the company said that they have a US FDA approval now. "We are not saying when we will launch. We have not decided anything as yet." Asked if RLL would launch the product in the first half of 2003, he said he could not comment.
Asked whether they feared litigation from GSK should they go ahead with the launch of the product, alleged to be made using bacteria derived from the stolen strain, the RLL official said he would not comment.
A leading industry source said RLL could be evaluating their own strength from the legal perspective before going ahead with launch. Another industry source said the launch would be possible only after the patent expires in December.
It may be recalled that GSK had claimed that RLL''''s product will be derived using the stolen bacteria as the strain is not available in the open market. If this is true, then there is no way RLL can go ahead with a launch and risk itself. In such a case, the company can wait for some more time and see the results of the GSK suit before even deciding to proceed.
Industry analysts say the launch may not happen soon as the company would wait to see the result of the litigation. Asked whether it is the stolen strain of bacteria that could be stopping RLL from going ahead, they say it is possible.
A generic drug is the brand equivalent, or bio-equivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are therapeutically equivalent to their branded counterparts, they are typically sold at substantial discounts from the branded price.
Since generic manufacturers have plenty of competition, lower R&D costs, and spend much less on advertising and marketing efforts, they are priced much lower than their branded counterparts in most cases.
According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more is saved when hospitals use generics.
RPI, a wholly-owned subsidiary of Ranbaxy Laboratories, established operations in the USA in 1994, and began marketing products in 1998 after receiving FDA approval for Cefaclor, a broad spectrum anti-infective agent. After four years of operations, RPI has achieved significant milestones by achieving sales of $109 m in 2001 - a growth of 80% over the previous year. Ranbaxy is positioned as the ninth largest generic pharmaceutical company in the world.