Cath Lab Digest

Since the US Food and Drug Administration approved Lipitor (atorvastatin) in the late 1990s, Pfizer, Inc, could rely on the cholesterol-lowering drug to generate billions in revenue. The product became the best-selling drug in history, providing a significant advantage for the company as it endured the industry’s cyclical nature.

No longer.

On November 30, 2011, Pfizer lost patent protection to atorvastatin. Watson Pharmaceuticals, Inc, now sells an authorized copy of atorvastatin, in which the company and Pfizer have a profit-sharing agreement for 5 years. Ranbaxy Laboratories, Ltd, also has a generic competitor. In May, there will be several more generic versions of atorvastatin available, including from Teva Pharmaceuticals.

Pfizer has attempted to hold on to as much market share as possible by implementing creative yet controversial deals, but the loss of atorvastatin is difficult to overcome in the near term. In 2011, atorvastatin generated $9.5 billion in worldwide sales and $5.0 billion in US sales.

Other pharmaceutical companies will soon be in similar situations. The patent for the blood thinner Plavix (clopidogrel), the second-highest selling drug in 2011, expires on May 17, contributing to billions in lost revenue for Sanofi and Bristol-Myers Squibb, its manufacturers.

This year, 10 drugs with at least $1 billion in US retail sales in 2010 will lose their patents, according to Medco Health Solutions data. Five more drugs in that category will lose their patents by the end of 2014. The products include Nexium (esomeprazole), Seroquel (quetiapine), Singulair (montelukast), and Actos (pioglitazone).

EvaluatePharma, a London research firm, published a report in June that noted drugs with $255 billion in annual sales will go off patent between 2011 and 2016. By 2015, generic drugs will have an 86% share of the pharmaceutical marketplace, up from 75.5% in 2010, according to Douglas Long, MBA, vice president of industry relations at IMS Health, a health information company.

The shift will help consumers save on prescription costs. IMS Health estimated the average copayment for generics was $6.06 per prescription in 2010 compared with $22.73 for branded generics, $23.65 for preferred brands, and $34.77 for nonpreferred brands.

However, major pharmaceutical companies will suffer with competition from generics. Some are taking innovative approaches to help preserve some of the revenue for as long as possible.

Pfizer has implemented several strategies. The company created a program called Lipitor For You, in which individuals covered by private insurance can pay as little as a $4 per month copay if their out-of-pocket expenses are <$54 for a monthly supply. If expenses are >$54, they can get up to $50 in monthly savings. People who are on Medicare, Medicaid, or other federal or state government programs do not qualify for the discount.

In early November, the New York Times obtained a letter from Catalyst Rx that revealed Pfizer had asked pharmacy benefit managers (PBMs) to block generic versions of atorvastatin for the first 6 months after the patent expired. If they complied, PBMs would receive large discounts from Pfizer. The newspaper reported the typical copayment for 30 days of atorvastatin was ≥$25 before the patent expired, but it would likely fall to $10.

A few weeks later, an advocacy group called Pharmacists United for Truth and Transparency released a memorandum from CVS Caremark to pharmacists that noted claims for generic atorvastatin would be rejected in favor of branded atorvastatin for Medicare Part D plans.