Lupin, Gavis to sell 2 drugs to fulfil US FTC condition

The US competition watchdog had noted that the merger would have also eliminated one of only a few companies likely to enter the market for generic mesalamine extended release capsules in the near future, thereby delaying beneficial competition and the prospect of price decreases.

Under the terms of the proposed order, Lupin was required to transfer to G&W Laboratories all of Gavis's rights and assets related to generic doxycycline monohydrate capsules no later than ten days after the acquisition is consummated, so that G&W can begin selling the product immediately.

The transfer includes Gavis's manufacturing technology, which Lupin will help G&W set up at the latter's facilities. In the interim, Lupin will supply G&W with the finished product for two years.

"The proposed consent order preserves competition by requiring the companies to divest these products to the New Jersey-based generic pharmaceutical company G&W Laboratories," FTC had said.

In July last year, the company had entered into a definitive agreement to acquire privately held GAVIS Pharmaceuticals LLC and Novel Laboratories Inc (GAVIS), subject to certain closing conditions, in a transaction valued at USD 880 million.

The buyout, the largest by an Indian pharma firm in the US, gives the Mumbai-based firm access to 66 generic drugs as well as broaden its pipeline in dermatology, controlled substance products and other high- value and niche generics.

The new entity would have a portfolio of over 110 in-market products, over 175 cumulative filings pending approval and a deep pipeline of products under development for the US.

The acquisition creates the fifth largest portfolio of abbreviated new drug application (ANDA) filings with the USFDA, addressing a USD 63.8 billion market.