This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity
Drugs without an Approved Generic (OPOE list). The list is a crucial
resource for promoting competition and affordability in the pharmaceutical
industry. Updated biannually in December and June, the OPOE list serves as a
transparent guide for drug manufacturers.
Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs).
ANDAs are a streamlined pathway for generic drug development,
offering a more cost-effective alternative to brand-name drugs. By highlighting
drugs that lack generic competition on the OPOE list, FDA aims to incentivize
manufacturers to develop generics, ultimately leading to greater affordability
and access for patients.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
ALS drugs, cancer, asthma,
HIV treatments among new drugs added to OPOE list
The December 2023 OPOE list had 23 new applications of branded
drugs eligible for but without generic competition. The June list further added
21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic
lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in
patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and
bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).
Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat.
The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller
This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and
others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product.
The agency considers first generics to be important to public
health and prioritizes review of these submissions. First generics are eligible
for a 180-day exclusivity period.
Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat
thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal
chromosome in their blood cells called the Philadelphia chromosome), got its
first generic in January, which was introduced by Apotex. Tasigna brought
in sales of US$ 1.85 billion in 2023 and its sales are
projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients
with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in
April.
Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved
drug to treat tardive dyskinesia, a disorder that involves involuntary
movements. It raked in US$ 1.84 billion in 2023, registering a
year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules.
Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)
Our view
The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or
a democrat takes over the US administration, making medicines affordable should
remain a priority.
In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.
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