12 Brand-Name Drugs That May Never Go Generic
A recent analysis by I-MAK reveals that drug makers have leveraged the patent system to prevent generic competition, retain monopolies on expensive drugs and raise drug prices. This research comes months after the Trump administration released the American Patients First blueprint for lowering drug prices. Among the many initiatives included in the blueprint, the administration discussed strategies for increasing access to affordable generic and biosimilar drugs.
Trump is set to make an announcement about drug prices later this week. While no specifics of the announcement are known, with the support of I-MAK’s research, it’s clear that preventing companies from over patenting drugs could be a good next step in curbing high drug costs.
How do manufacturers prevent generic competition?
When President Reagan signed the Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Amendments) in 1985, drug makers were given the leverage to place long-standing patents on their drugs—for essentially the first time ever. Originally, the Act was intended to spur new drug development, incentivizing manufacturers to create new medications and shoulder the expensive cost of research and development in exchange for up to 20 years of market exclusivity.
Drug makers have since found loopholes in the patent system and turned 20 years of price protection into nearly 50 years in some cases. How? By covering their drugs with hundreds of patents that have allowed them to prevent cheaper alternatives from being manufactured—and hike prices.
The top 12 grossing drugs of 2017 have an average of 71 issued patents and at least 31 more years of patent monopoly. Some—like Enbrel and Humira—can cost well over $5,000 for a one-month supply.
In some cases, the sheer number of patent applications that a manufacturer submits can be exorbitant. For example, Abbvie, the manufacturer of immunosuppressant drug Humira, applied for 247 patents for the drug, preventing a generic from entering the market for at least the next 39 years. Avastin and Rituxan, often used in cancer treatments, saw 219 and 204 patent applications, respectively.
In general, the more patents a drug has, the longer we will have to wait for a generic. Of the 12 drugs in the analysis, Humira is covered by the most patents, and cancer medication Herceptin is leading the board in terms of wait time for a generic to be released. Manufacturers of Herceptin, Roche and Genentech, have applied for 186 patents for the drug, resulting in 48 years of market exclusivity.
Manufacturer Pfizer tops the charts in terms of price increases since 2012, increasing the price of blockbuster drug Lyrica by 163% during that time. Lyrica’s patents, along with its unencumbered price hikes, has resulted in over $5 billion in global sales for Pfizer. Expect Lyrica to get even more expensive as Pfizer holds market exclusivity for another 32 years.
A note about biologics and biosimilars:
Keep in mind that some of the drugs on this list (like Humira, Lantus and Herceptin) are biologics, a class of drugs that include some of the most expensive medications in the world—here’s why this matters.
Biologic drugs are made out of living cells, which makes them notoriously difficult to replicate exactly, and are thus insulated from generic competition. In an effort to reduce the cost for these expensive biologics, the FDA has urged competitors to develop biosimilars, drugs that are similar to biologics already approved by the FDA. However, unlike a generic drug, biosimilars are not interchangeable with the original brand drugs, and are still quite expensive.
In other words, biologics on this list may never see a generic, and not because they are over-patented, but because they are near impossible to replicate.
So, what does this mean?
As you may have guessed, this probably doesn’t bode well for drug prices, and you’re right. In the past six years, the prices of four of these 12 drugs have more than doubled. What’s more, according to I-MAK, these 12 drugs cost health insurers, government payers and consumers a total of $96 billion in 2017 alone.
Manufacturers typically raise drug prices yearly, by as much as 10%. If manufacturers hold on to their monopolies for even the next 10 years, prices for these lifesaving drugs should continue to increase.
Is there anything being done to stop this?
Amid growing concern around drug spending, in May, President Trump called out manufacturers for exploiting the patent system, blaming them in part for the price of prescription drugs. In that same speech, Donald Trump indicated lowering drug prices was “one of [his] greatest priorities” and promised to release a plan to curb high drug prices. Unfortunately, no plan has been released yet.
Since that speech, the White House has called out specific manufacturers for their price hikes, but there has been little done to revamp the patent system. Stay tuned.
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