In 2022 and 2023, there are a number of big therapies losing patent exclusivity, which opens the door to generics that could save as much as $30 billion.
While knowing what drugs are under review the FDA for approval is important for payers looking to make formulary decisions, there are important legal and regulatory matters to keep in mind that could affect the launch of a generic or branded drug. During a session at the Academy of Managed Care Pharmacy’s annual meeting, Leslie Fish, RPh, PharmD, and Jeffrey Casberg, MS, RPh, both vice presidents of pharmacy at IPD Analytics, LLC, reviewed these potential barriers to launch as well as upcoming generic and traditional branded drug launches expected in 2022 or 2023.
There are numerous legal matters that could affect a generic launch, such as multiple patents on medications—as seen with the 100-plus for Humira—and settlement agreements between the brand and generic companies. Among the FDA issues are authorized generics, 505(b)(2) products, and 180-day exclusivity granted to the first generic to come to market.
Other FDA events that affect brand launches are Complete Response Letters (CRLs) and FDA advisory committees. Fish noted that in 2021 there were 50 novel drugs approved but 21 CRLs from the FDA. These can be issues for any number of reasons, including clinical effectiveness, safety, monitoring, and manufacturing issues. In 2022, there were 7 new drug approvals as of March 8 and 7 CRLs.
As for the FDA advisory committees, in 2021, there were less meetings, and the committees are becoming more selective. “And it almost looks like they're really holding back FDA committee meetings for those medications that can be controversial,” Fish said.
There are more than 30 generic launch potentials for 2022, and they cover more than 14 disease states, Casberg said. The potential savings for all these generics amounts to more than $30 billion.
He started with lacosamide (Vimpat), which is the top product in sales in the seizure category with 2021 sales of $2.3 billion. It lost its exclusivity in March 2022 and 6 generics entered the market with a few more coming.
“So, when you have that many generics, you're going to get a pretty fast price erosion,” Casberg said. “So, some big savings potential here in the CNS [central nervous system] category.”
Another drug in the CNS category is topiramate, which loses exclusivity in January 2023, and when it does, there are potentially 6 generics that will enter the market.
In the behavioral health category, there is vilazodone (Viibryd) to treat major depressive disorder, with a loss of exclusivity with 5 entrants. The real competitor is the branded drug vortioxetine (Trintellix). There is a lot of competition from branded and generic products, but Fish wondered if patients who need a lower copay or no copay will switch from other branded products to Viibryd once it becomes generic.
However, not all products with generic competition coming will see a price drop. For instance, benzoyl peroxide/clindamycin (Onexton), which has a wholesale acquisition cost of $666 per month, has 1 entrant when it loses exclusivity and Fish doesn’t expect to see the price drop much.
Then there are some older chemotherapy products in oncology that are still used but should have some good price alleviation, such as paclitexal (Abraxane) and octreotide (Sandostatin). Paclitexal will have 3 entrants and ocreotide only 1 entrant, and they both had more than $1 billion in sales in 2021.
Another oncology drug of note is bendamustine (Treanda powder and solution). The competitors for bendamustine are Bendeka and Belrapzo, which are 505(b)(2) products; most of the utilization is with Bendeka, which captured 80% of the market the first year it was approved.
The Treanda powder loses exclusivity in December 2022, and there are potentially 5-plus entrants. With that many entrants, the powder could become a lot less expensive and it’s possible that providers, hospital outpatient departments, oncologists, and others could go back to the powder form and Treanda.
“I do believe if the price is low enough, you will be seeing that aggressive management,” Fish said.
The multiple sclerosis space is interesting, because typically providers don’t do a lot of switching. If a patient is stable and doing well, then they stay on that treatment. However, fingolimod (Gilenya) loses its patent in 2023 and there are 10 or more potential generic filers, and teriflunomide (Aubagio) loses exclusivity in 2023 as well, with 10 generics.
Moving to new approvals, Casberg and Fish highlighted 12 drugs with potential approvals for supplemental new drug applications. Among these are:
Among the new drug application approvals coming up are:
One drug that Fish had been keeping an eye on for a while just received a CRL from the FDA on March 30, the day before the session at AMCP. Vadadustat is a hypoxia-inducible factor prolyl hydroxylase enzyme inhibitor to treat anemia due to chronic kidney disease (CKD) in both dialysis-dependent and non–dialysis-dependent patients. A few months earlier, roxadustat also received a CRL for the same indication.
“I do have to say I was a little surprised at vadadustat,” she said. “Because I didn't believe they’d get unlimited indication. I thought they would get the indication in CKD patients on dialysis. But they didn't—it was a CRL.”
Finally, Casberg looked at tirzepatide from Eli Lilly. The glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist is under FDA review as an add-on therapy to treat T2D, and it would be a direct competitor to semaglutide (Ozempic) from Novo Nordisk and Eli Lilly’s own dulaglutide (Trulicity). Tirzepatide will potentially be approved in the second quarter of 2022.
While the results from 5 phase 3 trials have been promising, they do not suggest tirzepatide will provide a paradigm shift in T2D treatment at the expense of the established GLP-1 receptor agonists, according to Casberg. Tirzepatide might be competitive to semaglutide at the highest dose, but at the lowest dose, tirzepatide could have the advantage.
“I think where the rubber meets the road here is whether specialists, endocrinologists, [primary care providers], will see this differentiation between tirzepatide, Ozempic, and Trulicity,” Casberg said. “Will they separate themselves?”