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What if your medication price suddenly dropped by 98%…
The year is 2019 and you go to the pharmacy to refill pregabalin, the epilepsy medication your life depends on. It has been two months since your last pick-up. The total pops up on the screen and your jaw drops. It’s about 98% cheaper than last time. Did the clerk mess up? Nope.
Why is it suddenly so cheap? Patents expire after 20 years. Pregabalin’s main patent ended June 30, 2019. Days later, the FDA cleared a wave of generics, and prices plummeted. That’s what happens when competitors can finally make the same thing. As much as we explore how patent filings are revolutionary, so are patent expiries.
For you, that price swing means money back in your pocket and fewer tough choices at the checkout. For the market, it’s a clean reset that invites new players and fresh deals.
To kick off the new year, this week’s newsletter will explore the pharmaceutical patents expiring in 2026 and how even patent expiries will change the world for the better.
The $200 Billion Patent Cliff


Pharmaceutical patent expiries catch the eye of IP nerds every year. When a pharmaceutical patent expires, it can drastically impact the price of medication as the expiration opens up opportunities for immediate generic entry. For 2026, the pharmaceutical expiries are being coined as the “$200 Billion Patent Cliff”!
Ozempic gets a trim!

This week, the first drug patent expiry is one you will know well, and has its own controversy in becoming more accessible to the masses…
What is expiring?
Yes, that’s right, the original semaglutide patent US 8536122 behind Ozempic starts expiring in big markets in 2026. You know the story by now. People with type 2 diabetes rely on it. Others chase it for weight loss. That mix made it both a lifeline and a lightning rod. (IQVIA)
For our chemists, the patent teaches a GLP-1 peptide tuned to last all week. It swaps the amino acid at position 8 to block DPP-IV breakdown, then adds a fatty side chain at lysine-26 via a linker so the drug “hitchhikes” on albumin and sticks around longer than 40 hours.
Why does Ozempic's patent expiry matter?
The 2026 clock matters because several large countries will see key semaglutide protections end, opening the door to local follow-ons and sharper price competition outside the U.S.. We’re already seeing early price moves in China as competition gathers and expiry nears.
What is already happening in the Chinese market?
Price cuts are already moving to get a competitive edge, with the top two doses of weight loss drugs in China already down 48% nearing the end of 2025.
Competitors Hangzhou Jiuyuan Gene Engineering and Livzon already filing for semaglutide copies, to prepare for a commercial launch post-Ozempic patent expiry.
Novo Nordisk, Ozempic developer, expanded their Tianjin site to compete with the new local players.
With another pharmaceutical procurement round upcoming, Ozempic related drugs are expected to face immense pressure to slash prices for bulk buyers.
In the U.S., secondary patents stretch into the early 2030s, so U.S. prices will likely adjust later and more slowly.
There’s an ethics angle we can’t skip. Doctors worry high list prices and off-label demand shut out the patients who need it most. Columbia’s Dr. Robert Klitzman warns that high costs and lifelong use can worsen disparities and crowd out prevention.
The exorbitant prices that manufacturers are asking my patients to pay for these novel diabetes and obesity medications are simply unacceptable.
Another interesting ripple is everyone’s grocery shopping cart. Households with an Ozempic user cut grocery spend roughly 5% within six months and trim snacks the most. British grocers are rolling out Ozempic friendly lines to meet the shift. (SAGE Journals)
What is happening in the weight-loss drug market?
FDA cleared Ozempic in late 2017, and by 2019 it was a blockbuster with about $1.63 billion in sales. That ramp barely slowed with roughly $17.45 billion in 2024 as demand spilled beyond diabetes into obesity care. IQVIA tracked GLP-1 prescription volume climbing from 0.68 million per month in Jan 2020 to 4.7 million by May 2025.

Novo Nordic Annual Reports (converted to USD as at date of our publication).
And the runway looks long. In 2024 the FDA said Wegovy is the first weight-loss drug proven to cut major cardiovascular events in high-risk patients, broadening medical demand. Analysts see the global obesity drug market reaching roughly $77 billion by 2030, with IQVIA estimating obesity-drug spending could push as high as $131 billion by 2028.
20-year lookback
From a 2017 FDA approval to a cultural flashpoint, semaglutide helped turn a diabetes drug class into a mainstream obesity treatment and briefly made Novo Nordisk Europe’s most valuable listed company before market leadership shifted again in 2025. A win for outcomes, yes, but the last two years also showed what happens when demand, off-label use, and sticker shock collide.
After two years of shortages, FDA now says semaglutide injections are back in steady supply. Novo Nordisk has been buying and building capacity, including three Catalent fill-finish sites and new U.S. production, to keep pens flowing as more markets open. (U.S. Food and Drug Administration)
Mental health meds face a price slash

What is expiring?
Trintellix, the antidepressant from Lundbeck and Takeda (US 7144884) that claims a family of phenyl-piperazine compounds used to treat depression and anxiety. The drug aims at serotonin-reuptake-inhibiting molecules for affective disorders. If you’re mapping this to the pill in your cabinet, vortioxetine is one of the specific exemplars listed in the claims set.
Why does Trintellix's patent expiry matter?
Access to Trintellix is where price stings. The list price for Trintellix is about $514 for 30 days, and typical retail quotes hover in the $466–$576 range before insurance or coupons. A 2021 study of Medicare beneficiaries on antidepressants found 16.6% had cost-related medication nonadherence, and another analysis linked antidepressant nonadherence to more hospitalizations, more ER use, and higher total medical costs. In short, high out-of-pocket costs can worsen the condition they’re meant to treat.
Or as the WHO puts it,
“Depression is the leading cause of ill health and disability worldwide”,
and relieving these individuals by shaving costs after is a budget win and a clinical one.
In the U.S., this drug has served hundreds of thousands of patients each year. For example, ClinCalc’s MEPS-based dashboard counted about 346,000 patients in 2016 and 308,000 in 2019, alongside roughly 1.1–1.7 million annual prescriptions. That’s a meaningful slice of people in treatment when you zoom out and see that 11.4% of U.S. adults took prescription medication for depression in 2023.
Lundbeck has already told investors it’s treating 2026 as the loss-of-exclusivity year in the U.S. That’s your signal that a generic race is lining up. (nasdaq)
Competitors are not hypothetical. FDA has issued tentative approvals for multiple generic vortioxetine tablets (e.g., Cipla 2018; others in 2019–2021), but final launch is blocked until the listed patents and exclusivities expire. That’s the classic “green light later” setup you see right before a cliff.
What does that mean for price? Across many drugs, FDA and HHS data show invoice-level prices often drop about 15–35% with the first one to three generics, then 70–95% as more rivals pile in. (JAMA Network)
What is happening in the Trintellix drug market?
Lundbeck reported $700+ million in 2024 revenue from Brintellix/Trintellix, growing double digits as it preps for the handoff to Takeda in the U.S. ahead of expiry. As exclusivity lapses, expect formulary shake-ups, step edits toward generics, and sharper rebates to defend share. (lundbeck.com)
Lundbeck is already bracing for Trintellix’s 2026 cliff by handing the U.S. wheel to partner Takeda and moving to a royalty-only model for 2025–2026, freeing up its sales budget to push Rexulti and other growth bets. (Cision)
The companies amended their deal so Lundbeck stops all U.S. promotion from Jan 1, 2025 while collecting a fixed royalty on net sales. Lundbeck’s guidance now frames 2026 as the U.S. loss-of-exclusivity year to be “bridged” by pipeline and brand investments.
Takeda continues to defend the compound patent that runs to June 17, 2026 (with pediatric extension to Dec 17, 2026), while Lundbeck tells investors it’s loading the funnel, targeting multiple Phase 3s and new launches before 2030. (A&O Shearman)
20-year lookback
Two decades ago, this chemistry captured a mood-disorder moment. Previous medications worked but were slow and messy for many patients, so teams chased faster onset and cleaner tolerability. Vortioxetine rode that wave to global sales and millions of prescriptions.
Xarelto hits Europe’s 2026 Patent Cliff

What is expiring?
Bayer’s European patent EP 1 845 961 covers the once-daily regimen for rivaroxaban, the oral Factor Xa blocker behind Xarelto. Xarelto (rivaroxaban) is the daily blood thinner for three big jobs.
Cut stroke risk in atrial fibrillation
Treat and prevent DVT/PE clots; and
(At low dose with aspirin) Lower heart-event risk in CAD/PAD.
Why does Xarelto's patent expiry matter?
When the EU patent expires, most EU markets open to broader rivaroxaban generics.
What happened in Germany already?
We’ve already seen evidence of what will happen, as Germany’s court struck down the patent nationally in 2025, and Sandoz launched generic rivaroxaban there soon after.
Pharmacies saw list prices drop days after launch. Ratiopharm and Zentiva packs “about halved,” and Aristo cut “by two-thirds,” per trade press. A regional medical association told prescribers the new generics were “up to 70% cheaper than the original.” (APOTHEKE ADHOC)
German sickness funds quickly tendered rebate contracts for rivaroxaban (e.g., IKK classic, Spectrum K, GWQ), locking in lower net prices for 2026–2028. In parallel, the G-BA had already moved to create a reference-price group for rivaroxaban in April 2025, a policy lever that further drags prices down.
The generics association Pro Generika projected ~€0.5 billion annual savings to Germany’s statutory insurers from rivaroxaban generics, consistent with the steep post-launch cuts seen at pharmacy wholesale.
Expect more countries to follow at or after the January 2026 date, with tender rounds pulling prices down.
For the U.S., Medicare has already set a 2026 “negotiated” price for brand Xarelto of $197 for 30 days, down from a $517 list in 2023 (a 62% cut for Part D seniors). And the FDA approved the first U.S. generics (2.5 mg) in March 2025 for CAD/PAD, with more strengths expected as patents/exclusivities clear. In 2023, 1.324 million Medicare beneficiaries used Xarelto, with $6.31 billion in gross Part D spend, so even measured price steps move real money. (Centers for Medicare & Medicaid Services U.S. Food and Drug Administration)
Analyses put global anticoagulant sales in the tens of billions annually, and industry trackers flag pricing wars as generics land post-patent.
Xarelto has a huge addressable crowd. At least 10.55 million Americans are predicted to have Afib, up to 900,000 face a VTE each year, and 1.32 million Medicare users took Xarelto in the latest year CMS tallied. In short, there is a large market of long-term users across Xarelto related heart and clot care. (aspe.hhs.gov)
Hospitals and payers will re-bid anticoagulant contracts, with generics slotted as first-line where clinically appropriate. In parallel, Medicare’s negotiated price becomes the new floor in 2026, then actual generics add a second leg down as more doses go off-protection. For patients, that’s lower expenses on lifelong meds. For systems, it’s nine-figure savings when you zoom out across stroke prevention, DVT/PE treatment, and CAD/PAD. (Centers for Medicare & Medicaid Services U.S. Food and Drug Administration)
20-year lookback
Clinically, this is the end of an era Xarelto helped start in replacing warfarin with direct oral anticoagulants. The 2011 ROCKET-AF trial showed rivaroxaban was noninferior to warfarin for preventing stroke/systemic embolism in atrial fibrillation, and once-daily dosing made life simpler than INR checks and diet rules.
The paper boy always delivers

Patent expiries are revolutions themselves. They end tollbooths, invite new makers, and nudge prices down.
Today’s tour proves it. Ozempic’s core semaglutide patent starts coming off in big markets (US 8536122). Trintellix’s compound claim hits its 2026 wall (US 7144884). And Xarelto’s once-daily dosing patent in Europe times out (EP 1845961), with U.S. pressure from negotiated prices and first generics already in motion.
Forward to a friend to kick start the year right together!

The Hot off the Patent Press team wishes you a Happy New Year!!
For the nerds

GLP-1 Impact with IQVIA: Explore how GLP-1 prescriptions exploded from 680,000 per month in Jan 2020 to 4.7 million by May 2025, and what that means for Ozempic’s demand curve.
FDA cardiovascular label: Dig into the FDA’s approval making Wegovy the first weight-loss drug with a cardiovascular-risk-reduction indication, the clinical backdrop for broader semaglutide use.
Medicare 2026 negotiated prices with CMS: See the official list for the first negotiation cycle, useful for benchmarking Xarelto’s 2026 Maximum Fair Price.
Rivaroxaban goes generic in Germany with Sandoz: Track the EU playbook as generics launch post-patent, a preview of pricing pressure around Xarelto’s European cliff.
