* Judge prevents generic Lyrica until 2018
* Generic makers claimed new formulation of drug
* Ruling protects Pfizer's No. 2 selling drug
By Tom Hals
July 19 Pfizer Inc beat back a challenge from
generic drugmakers to a patent that protects its pain medicine
Lyrica, its second-best selling drug when a federal judge ruled
in its favor on Thursday.
Judge Gregory Sleet of the U.S. District Court in Delaware
issued an order preventing the manufacture of generic versions
of Lyrica before its patent protection expires in 2018. Some
generic drugmakers had hoped to launch their versions as soon as
Industry analyst Mark Schoenebaum of ISI Group said a
generic challenge to Lyrica could have cut Pfizer's earnings per
share by as much as 17 cents in the next five years.
The generic drugmakers argued they could produce a
clinically identical drug using a formulation that was not
Patent rulings are often appealed.
Pfizer reported worldwide first quarter Lyrica sales of $955
million, making it second only to its cholesterol fighter
Lipitor, which is fast losing revenue in the face of competition
from cheaper generic versions.
U.S. Lyrica sales in the quarter were $395 million.
Lyrica is used to treat fibromyalgia, diabetic nerve pain,
post herpetic neuralgia - or pain following a case of shingles -
and seizures in adults with epilepsy.
In June, the Food and Drug Administration approved Lyrica as
a treatment for nerve pain associated with spinal cord injuries.
The generic companies challenging the Lyrica patent were
units of Teva Pharmaceutical Industries Inc of Israel,
Lupin Ltd and Sun Pharmaceutical Industries Inc
of India, U.S.-based Mylan Inc and U.S.-based
Watson Pharmaceuticals Inc.