Federal Judge Sides With FDA in Colchicine 505(b)(2) Approval Lawsuit

Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys.

The D.C. district court judge denied several motions for summary judgment that would have automatically awarded Takeda a permanent ban on Mitigare’s (colchicine) approval. The court gave the company until Jan. 23 to show why the case shouldn’t be dismissed outright. Takeda has already moved to appeal.

The ruling stems from Takeda’s October suit against the FDA for allowing Hikma to cite another colchicine product, ColBenemid, in its 505(b)(2) application for approval, thus skirting a patent infringement lawsuit over Colcrys.

Takeda charged that the FDA decision would create a public health risk because Hikma couldn’t cite Colcrys’ safety warning on toxicity of colchicine when mixed with other drugs, as its application was based on another product.

Hikma defended the drug’s approval, pointing out that Mitigare is not an exact copy of Colcrys because it is a capsule while Colcrys is a tablet. Mitigare’s approval also does not include all of Colcrys’ indications.

As for the safety concerns, Hikma says Mitigare’s label specifically warns against using the drug with other products known to cause harmful reactions with colchicine.

Meanwhile, Takeda seems to be trying to mitigate the damage a competitor might cause by launching an authorized generic version of Colcrys with Prasco. The copy will be marketed under the Prasco label. Colcrys’ patent doesn’t expire until 2029. – Bryan Koenig and Jonathon Shacat