Blockbuster drug patent expirations in 2026 and what they mean

2026 will see some significant drugs lose their patent protection. In particular, the drugs discussed here are considered to be blockbusters, which means they've generated annual sales of at least $1 billion in the U.S.¹

Expiring drug patents might be bad news for their manufacturers, who stand to lose important revenue streams. But they’re very good news for plan sponsors and consumers. That’s because they open the door for generic and biosimilar medications, which deliver comparable quality at a significantly lower price.

Generic medications contain the same active ingredients, at the same strength and purity, as their brand-name counterparts. Biosimilars are lower-cost versions of biologic medications that are highly similar to, and with no clinically meaningful differences from, an existing U.S. Food and Drug Administration (FDA)-approved biologic drug.²

The key question for expiring drug patents is whether there are generic/biosimilar competitors ready to reach the market. Often, we'll see that competing drugs have been approved by the FDA but held back from the market. This could be the result of various legal settlements, or because the relevant patents are still in effect.

The number of generic/biosimilar competitors is also important. For example, at Optum Rx® we know the average list price of the first new generic drug is often 10–15% lower than the brand version. But prices will usually continue to fall as more generics enter the market.

In 2025, the U.S. Department of Health and Human Services (HHS) published a summary review of generic list price data covering studies conducted from 1995 through 2024. These studies found that prices declined by about 15–40% in markets with 3–5 competitors and by 60–90% in markets of 10 or more competitors.³

The market for biosimilars functions much differently than for generics, but the net result is similar. First, biosimilar medications cost less. A different HHS study from last year reports that biosimilar list prices are on average more than 50% less than the branded biologics.⁴ In addition, once a biosimilar enters a market, branded biologics respond by lowering their prices by about 25% on average.⁵ And more competition produces more savings, just like for the generics.

A third recent study found that each additional biosimilar competitor produces an additional 10–13% list price decrease compared to the original branded price.⁶

Here’s a summary of the medications we’ll discuss:

Indications: Asthma, chronic idiopathic urticaria, chronic rhinosinusitis with nasal polyps, food allergies
Manufacturer: Roche
2025 U.S. sales: $3.7 billion

The U.S. patent for Xolair (a biologic medication) expired in November 2025.⁷

The FDA approved all dosing versions of Omlyclo® (omalizumab-igec), across all 4 of Xolair’s indications. It’s expected to enter the U.S. market by September 1, 2026.⁸

Omlyclo is designated as an interchangeable, which means pharmacists can replace the brand-name medication at the counter without a doctor’s prescription.⁹

No price has been announced for Omlyclo yet. For reference, Xolair’s wholesale acquisition cost (WAC) ranges from approximately $1,400 per 150mg dose to over $2,800 for a 300mg dose.¹⁰

Indications: Multiple myeloma, Kaposi’s sarcoma
Manufacturer: Bristol Myers Squibb
2025 U.S. sales: $2.34 billion

Bristol Myers Squibb faces immediate generic competition in the U.S. for Pomalyst. So far, 6 companies have gained FDA approval for their Pomalyst generic versions. Of these, 4 are currently available for sale covering all 4 existing dosage strengths.¹¹

The retail price for Pomalyst is approximately $24,500 for 21 capsules.¹² However, generic versions are available beginning at $18,900 for the same number of capsules, about 23% less.¹³

Indications: Pulmonary arterial hypertension (PAH)
Manufacturer: Johnson & Johnson
2025 U.S. sales: $1.63 billion

Opsumit is expected to face generic competition soon. In fact, the FDA has already approved 5 generic versions beginning in 2023. However, none of them are currently available for sale in the U.S.¹⁴

Indications: Type 2 diabetes
Manufacturer: Merck & Co.
2025 U.S. sales: $1.27 billion

Januvia and Janumet are expected to lose market exclusivity in May of this year, with Janumet XR following suit in July. The FDA has already approved generic versions of Januvia from 3 manufacturers, although none are available for sale yet.¹⁵ There is also 1 approved generic of Janumet, although it’s not yet in market either.¹⁶

While Merck & Co. still has a couple of months before generics of its long-running diabetes franchise Januvia and Janumet take hold, and slightly longer still on its extended-release version of Janumet, copycat competition appears inevitable before year end.

Beyond the 4 generic versions mentioned above, Merck has agreements with at least 25 generic drugmakers enabling their launches this year, according to a filing from 2023.¹⁷

Indications: Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritisype
Manufacturer: Janssen Biotech, Inc. (A subsidiary of Johnson & Johnson)
2025 U.S. sales: $1.19 billion

As Simponi loses patent protection, it’s unclear when a competing biosimilar medication will be available. There are 2 candidates, but both face regulatory or legal uncertainties.

Drugmakers Teva and Alvotech are collaborating on a Simponi biosimilar currently named ATV05. But in November of last year, the FDA paused their approval process after noting problems with Alvotech's manufacturing facility in Reykjavik, Iceland.¹⁸ Those issues need to be resolved before approval, but as of now, there’s no clear date set.

Separately, Bio-Thera has partnered with Accord BioPharma on another Simponi biosimilar called golimumab. The FDA is expected to issue a decision by May 16. But in March of this year, Janssen Biotech filed suit against Accord and Bio-Thera Solutions, alleging their biosimilar infringes 17 patents, generally regarding manufacturing and method-of-treatment. Presently there is no timetable regarding when biosimilar Simponi might be available.¹⁹

Optum Rx continuously monitors the medication pipeline — not just for new medications, but also for new generic and biosimilar versions. Many of the generic and biosimilar medications mentioned here should be coming to market in the near to mid term. You can trust us to keep you apprised of when that happens and, most importantly, how to plan for and respond to those additions to the market.