AMCP: Generic availability more important than patent expiration

In yesterday’s pipeline update, Chris Peterson, PharmD, a director in the Emerging Therapeutics department at Express Scripts, reviewed the trend in FDA approvals and noted several of the key therapeutic areas with recent generics.

In the product landscape, 2014 patent expirations represent more than $22 billion in sales, while the next two years represent $16 billion to $17 billion.

“There’s a lot of patent activity in 2014,” Peterson said.

Health plans are interested in the cost savings associated with the new generics. For example, on May 30, generics will be available for Pfizer’s Celebrex from at least two manufacturers, pending on FDA approval.

“Generic availability is what’s important,” Peterson said. “No one really cares about patent expiration.”

In the diabetes therapeutic area, Nesina (Jan. 2013); Invokana (Mar. 2013); and Farxiga (Jan. 2014) are three new brands. Recent generics include Actos (Aug. 2012); ActoPlus Met (Aug. 2012); Duetact (Jan. 2013); and Prandin (July 2013).

Five DPP-4 inhibitors and five SGLT-2 inhibitors are in the pipeline, mostly in phase 2 or 3, however, Jardiance (empagliflozin), one of the SGLT-2 inhibitors, is expected to receive approval in the second half of 2014.

SGLT-2 inhibitors are the newest class of diabetes drugs. Last year, the first SGLT-2 was approved and there are two competitors in this category right now.

“By end of 2014 we expect three competitors in the SGLT-2 inhibitors,” he said. “This will be the next billion-dollar class to watch.”

Also in diabetes, four GLP-1 analogs and six insulin drugs are in various stages of development.

“Insulin is a $12 billion market, and about half of that is in long-acting products,” Peterson said.

He also says to watch for the second inhaled insulin drug to reach the market this year-the first was Exubera by Pfizer in 2006. The new drug, Afrezza, is likely to win approval in its third attempt by MannKind Corp. An FDA advisory panel on March 31 voted 13-to-1 to recommend Afrezza approval for patients with type 1 diabetes and unanimously backed it for those with type 2, but said longer-term studies would be required to examine side effects.

OTC Pipeline

Likewise, possible over-the-counter (OTC) product are also close to market, Peterson said.

Lipitor could become an OTC in 2015. There is a pathway to take it OTC, but Pfizer is conducting consumer-use studies right now. The study will conclude by the end of December so the market could see OTC Lipitor in 2015, depending on the results.

There are several factors that might make the Lipitor OTC product favorable including new guidelines on liver testing, he said.

FDA recently approved OTC esomeprazole 20 mg (Nexium 24HR, Pfizer).