Pfizer looks set to develop an over-the-counter (OTC) version of Lipitor to combat the loss of patent exclusivity on the world’s best-selling drug.
Lipitor loses its patent protection in November but Pfizer hopes to retain some of the $11bn revenue through the non-prescription version.
Raymond Kerins Jr., a Pfizer spokesperson, says the company does have “strategic plans in place for Lipitor” but refused to elaborate further.
But Pfizer’s plans may be halted if the FDA fails to grant the new version approval for use without a doctor’s supervision.
The FDA has previously questioned whether OTC versions could be used safely.
Consequently, approvals of prescription to OTC versions have been rare in recent years in the US. Merck failed on three occasions to win Agency approval for a non-prescription version of its statin Mevacor. Bristol-Myers Squibb also failed to gain approval for its alternative version of Pravachol.
However, Johnson & Johnson’s OTC version of allergy drug Zyrtec has been commercially successful, as has been Claritin, which generated sales in excess of $400 million in 2010.