Celgene’s Day in Court With Barr Over Generic Thalidomide Approaching

In the '50s and '60s thousands of pregnant women all over the world took thalidomide to prevent morning sickness. However, the drug was banned after many of these women gave birth to babies with severe birth defects. Now that researchers have discovered new uses for thalidomide, it has become so widely prescribed that generic drug companies are pursuing it.

On Wednesday, December 13, 2006, Celgene Corp. (CELG) announced that it had received notification from Barr Laboratories, Inc. (BRL) that Barr had filed an ANDA for generic thalidomide, 200 mg tablets, sold by Celgene under the brand name Thalomid. On December 26, 2006, Celgene announced that it had received notification of Barr's ANDA for the 50 and 100 mg strengths of Thalomid. The ANDAs contained paragraph IV certifications that any applicable Celgene patents are invalid, unenforceable, and/or not infringed.

Thalomid was Celgene's top-selling drug last year, with sales of about $388 million. Thalomid sales are expected to reach around $430 million this year and fall to around $265 million by 2010 as Celgene's other thalidomide drug, Revlimid, hits the market.

There are ten patents listed in the FDA's Orange Book as covering Thalomid. Although Thalomid must be used with caution, when used properly it may be prescribed in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma, for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum [ENL], as well as for maintenance therapy for the prevention and suppression of cutaneous manifestations of ENL recurrence, according to the Orange Book use codes.

Assuming that Celgene received Barr's notice on December 13, 2006, for the 200 mg tablets, then Celgene would have until about Saturday, January 27, 2007, to file a patent infringement lawsuit against Barr for the 200 mg tablets pursuant to 21 U.S.C. 355(j)(5)[B](iii). Of course, if Celgene received Barr's notice earlier than December 13, 2006, then its statutory 45-day clock would expire earlier than January 27th.

Likewise, assuming that Celgene received Barr's notice for the 50 and 100 mg tablets on December 26, 2006, then Celgene would have until about Friday, February 6, 2007, to file its lawsuit against Barr for those dosages, or earlier if Barr's notice was received earlier.

If and when Celgene files suit against Barr, we will add the case to the Hatch-Waxman Tracker.

CELG vs. BRL 1-yr chart