Mylan, FDA Granted Favorable Summary Judgment By Court On Generic Precedex

(RTTNews) - Generic drug maker Mylan, Inc. (MYL) and the U.S. Food and Drug Administration or FDA, have been on Monday granted a favorable summary judgment related to generic Precedex. The U.S. District Court for the District of Maryland has allowed Mylan to immediately resume distribution of its generic Precedex product.

The court also lifted a previously entered temporary restraining order against Mylan and other companies related to generic Precedex.

Generic Precedex or dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL single-dose vials, was approved by the FDA as therapeutically equivalent to pharmaceutical and medication delivery company Hospira, Inc.'s (HSP) Precedex.

A federal judge on August 20 granted a temporary restraining order against the FDA's decision to allow the sale of generic versions of Hospira's proprietary sedative drug Precedex (dexmedetomidine HCl injection).

The drug accounted for 11 percent of Hospira's global net sales of $4.1 billion in 2013, according to Hospira's recent annual report.

Lake Forest, Illinois-based Hospira holds a patent on its flagship sedative Precedex relating to intensive care unit sedation which will expire only in 2019. However, the patent that covers use in patients without breathing tubes before and during surgeries and other procedures is said to have already expired.

On August 18, the FDA had approved the generic versions for sale as long as the labels do not carry any information about the drug's use for intensive care unit sedation and contain information on only other indications of the drug. Mylan launched its drug immediately after the FDA approval on the same day.

After two days, U.S. District Judge George Jarrod Hazel, however, stayed the FDA's decision to allow the sale of generic Precedex and also ordered the FDA to recall any product sold or distributed under its decision. The order remained in effect until September 2.

The judge said the potential harm suffered by Hospira from the immediate availability of generics would far exceed what would be suffered by the FDA or Mylan.

Generic drug companies Mylan and Sandoz, Inc. were to gain by the FDA approval. Mylan had gained approval to sell the generic version of Precedex for the sedation of non-intubated patients preceding and/or during surgical and other procedures.

Sandoz, the generic arm of Swiss drugmaker Novartis AG (NVS), was also set to start selling the generic version of Precedex after reaching a settlement on a patent litigation with Hospira, which gave Sandoz an exclusive right to sell the generic drug for six months.

Following the FDA approval to Mylan and Sandoz, Hospira challenged the order and had sought a temporary restraining order in a lawsuit filed in U.S. District Court of Maryland against the FDA's decision. The company argued that FDA's decision to allow sale of the generic versions of Precedex was against its own rules and violates Hospira's patent.

Precedex is a relatively selective alpha2-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting as well as for sedation of non-intubated patients prior to and/or during surgical and other procedures.

MYL closed Friday's regular trading session at $46.98, up $0.13 on a volume of 6.31 million shares, and HSP closed at $53.90, up $0.40 on a volume of 0.92 million shares.