Lupin files more ANDAs to combat delay in generic approvals by FDA

Mumbai-based drugmaker Lupin Ltd is positive about its performance in the US market, irrespective of delays in getting approvals for its products from the regulatory watchdog, Food and Drug Administration (FDA).

Kamal K Sharma, managing director, Lupin, said that from an average 14 months, abbreviated new drug application (ANDA) approvals, which are needed for launching generics in the US market, are now taking about 30 months.

Staff crunch to monitor and grant approvals at the FDA office and a huge backlog on account of a surge in filings by generics makers is causing the delay, he said.

Estimates by the Generic Pharmaceutical Association suggest that the FDA’s Office of Generic Drugs (OGD) had a backlog of about 1912 applications by various firms. This has increased the median approval time from about 5 months to 26.7 months.

“When delays happen, they do affect you. If I expect to launch 18 products, I actually end up launching just 8-10,” said Sharma.
Sharma said the company suffered in the US in 2010-11 due to the delays.

Its growth in that market last financial year was about 27%, as against an average annual growth of 35%.

“However in future we should be optimistic about 32% growth.”
Sharma said this optimism comes from its strategy of having a bigger pipeline of ANDA filings.

“We presently have 48 ANDA approvals, while about 100 filings are still awaiting approvals. Each year we plan to make about 25-30 filings. By making more filings and having a larger base, we can lessen the impact of this delay,” said Sharma.

Sujay Shetty, associate director, PricewaterhouseCoopers, said making an ANDA filing is an expensive task and so any delay on this front can prove costly for companies, especially if the product is a generic of a blockbuster molecule.

“However, such an issue affects all companies including the US ones. No company can ignore the market and should not get deterred from making filings.”

Margins from US range between 14% and 20% depending upon the product category, and experts believe the backlog and delay in approvals will lead to revenues being deferred.

Sharma said the firm is also looking at lessening the impact of the delay by focusing on other geographies such as Japan, India, EU and South Africa.

“In EU we grew this time by 30%, 32% in South Africa, and 18% in India. This spread helps in combating the delay happening in one geography.”