UPDATE: Mylan Considers June Launch Of Generic Lipitor In Suit Vs FDA
21 Mars 2011 - 8:54PM
Dow Jones News
Generic-drug maker Mylan Inc. (MYL) has sued the U.S. Food and
Drug Administration in an effort to allow the introduction of
generic versions of Pfizer Inc.'s (PFE) popular
cholesterol-lowering drug Lipitor in June, five months earlier than
expected.
Mylan wants a federal judge to force the FDA to deny an
application by rival Ranbaxy Laboratories Ltd. (500359.BY) to sell
generic Lipitor, and to deny Ranbaxy a six-month period of market
exclusivity for the copycat product following its anticipated
introduction in November. Mylan filed its lawsuit in federal court
in Washington on Friday.
Ranbaxy has been expecting a six-month exclusivity period
because it was the first to file for FDA approval of a generic
version of Lipitor several years ago. Also, Ranbaxy agreed to wait
until Nov. 30 to launch its generic product as part of a 2008
settlement of long-running patent litigation with Pfizer.
But questions have been mounting about whether Ranbaxy will be
in a position to sell generic Lipitor in November, and Mylan's
lawsuit further clouds the picture.
The FDA has cited Ranbaxy for manufacturing deficiencies at
plants in India, and has accused the company of providing falsified
data and test results in drug applications to the agency.
Mylan claims in its lawsuit that Ranbaxy has engaged in a
pattern of submitting drug applications to the FDA containing false
and unreliable data regarding a Ranbaxy manufacturing plant in
India. Mylan accused the FDA of failing to enforce its "application
integrity policy" against Ranbaxy, which Mylan says should result
in denial of Ranbaxy's application to market generic Lipitor.
Mylan says generic versions of Lipitor should be allowed to
enter the market in June because that is when Pfizer's exclusivity
associated with one of the patents for Lipitor expires.
"We believe the FDA has all the information its needs to decide
today on Ranbaxy's 180-day exclusivity," said Mylan spokeswoman
Nina Devlin. She said the company couldn't comment further on the
litigation.
FDA spokeswoman Sandy Walsh said the agency doesn't comment on
lawsuits.
Pfizer spokesman Chris Loder said it would be inappropriate for
the company to comment because it hasn't had a chance to review the
complaint.
A Ranbaxy spokesman couldn't immediately be reached.
Lipitor is the top-selling drug in the world, generating global
sales of $10.7 billion for 2010, $5.3 billion of which came from
the U.S. An earlier-than-expected launch of generic Lipitor would
be a big blow to Pfizer's 2011 sales.
In its lawsuit, Mylan estimated consumers and insurers could
save between $10.9 million and $18.6 million per day when generic
Lipitor becomes available by paying lower prices for the generic
versions.
Barclays Capital said in a research note Monday it was unlikely
that the FDA would strip Ranbaxy of its six-month exclusivity
period. "We believe that the agency will allow Ranbaxy to continue
making efforts to gain approval, for the foreseeable future," the
firm said.
Pfizer has granted Watson Laboratories Inc. (WPI) a license to
sell what is known as an authorized-generic version of Lipitor
beginning in November; Pfizer will supply the product.
Mylan had previously challenged the validity of patents for
Lipitor in an effort to sell a generic version of the drug.
Litigation arising from the challenge was settled in January on
confidential terms, according to Pfizer's annual report.
Under federal law, the first successful generic challenger is
awarded a 180-day exclusivity period from when it launches, but
regulatory and manufacturing issues at Ranbaxy may delay an
approval. If that occurred, barring a decision favorable to Mylan
in its new lawsuit, other generic manufacturers may be blocked from
selling a generic version of Lipitor until Ranbaxy's exclusivity
expired, leaving Watson as the sole generic supplier beginning in
November.
Pfizer has also settled Lipitor patent litigation with Teva
Pharmaceutical Industries Ltd. (TEVA) and analysts have generally
expected Teva to begin selling its generic version in mid-2012, at
the same time Mylan had been expected to launch.
Pfizer sahres fell 20 cents to $19.98 in recent trading. Mylan
was up 14 cents at $21.80; Watson rose 57 cents to $54.88.
-By Peter Loftus, Dow Jones Newswires; 1-215-982-5581;
peter.loftus@dowjones.com