Top 10 Drug Launches & Patent Cliffs (2026 Update): 2025's Full-Year Scorecard
Updated September 2026 — this article merges and fully updates our June 2025 reports on the year's most anticipated drug launches and biggest patent cliffs, now with confirmed FDA outcomes, real launch sales, and a fresh look at 2026.
Every January, industry analyst firm Evaluate publishes two mirror-image forecasts: the drugs Big Pharma hopes will become the next blockbusters, and the drugs about to fall off a patent cliff into generic and biosimilar competition. We covered both lists for 2025 when they were still predictions. Eighteen months on, the predictions have collided with reality — a few spectacularly, most in more mundane ways typical of drug launches. Below, we score all 20 of last year's drugs against what actually happened, then turn to Evaluate's newly published 2026 slate on both sides of the ledger.
Quick Answer
Eight of 2025's 10 most-anticipated drug launches reached the U.S. market: Vertex's Alyftrek and Journavx, AstraZeneca/Daiichi Sankyo's Datroway (in a second, lung-cancer indication), Cytokinetics' Myqorzo (aficamten), Insmed's Brinsupri, GSK's Exdensur and Penmenvy, and J&J's Imaavy. Sanofi's tolebrutinib was rejected by the FDA in December 2025, and Innovent's mazdutide launched only in China. On the patent-cliff side, Novartis's Entresto lost its court fight and saw generics arrive in July 2025 — over a year earlier than the company had hoped — while J&J's Simponi unexpectedly held onto exclusivity after a rival biosimilar's manufacturing problems, and remains on the "drugs losing exclusivity" list again in 2026. For 2026, Novo Nordisk's CagriSema and Eli Lilly's orforglipron top a launch slate that Evaluate projects at a combined $45.9 billion in 2032 sales — more than 50% above 2025's list.
In this article
2025's Most Anticipated Drug Launches — The Scorecard
When Evaluate published its 2025 preview, the firm projected the year's top 10 launches would generate a combined $29 billion in annual sales by 2030 — nearly double the prior year's forecast. Vertex's cystic fibrosis drug Alyftrek topped the list at an estimated $8.3 billion, trailed by AstraZeneca and Daiichi Sankyo's antibody-drug conjugate datopotamab deruxtecan and Vertex's non-opioid pain candidate suzetrigine. Here's how each of the 10 actually fared.
| Drug | Company | 2030 est. (2025 forecast) | What actually happened |
|---|---|---|---|
| Alyftrek | Vertex | $8.3B | Delivered — strong launch, ~$247M in Q3 2025 sales alone |
| Datroway (Dato-DXd) | Daiichi Sankyo / AstraZeneca | $5.9B | Delivered — won the lung-cancer approval analysts were watching for |
| Journavx (suzetrigine) | Vertex | $2.9B | Approved, but launch badly lagged estimates |
| Myqorzo (aficamten) | Cytokinetics | $2.8B | Delivered late — approved Dec. 19, 2025 after a 3-month delay |
| Brinsupri (brensocatib) | Insmed | $2.8B | Delivered — first-ever approved bronchiectasis drug |
| Mazdutide | Innovent / Eli Lilly | $1.3B | China-only so far — not yet filed with the FDA |
| Tolebrutinib | Sanofi | $1.4B | Rejected — FDA complete response letter, Dec. 24, 2025 |
| Exdensur (depemokimab) | GSK | $1.2B | Delivered — approved for severe eosinophilic asthma |
| Penmenvy | GSK | $1.2B | Delivered — approved Feb. 14, 2025 |
| Imaavy (nipocalimab) | Johnson & Johnson | $1.2B | Delivered, and expanding — 2nd approval (warm AIHA) landed Aug. 2026 |
1. Alyftrek (Vertex) — the safest bet paid off
Vertex's fifth cystic fibrosis medicine, already approved in December 2024, spent 2025 doing exactly what a franchise drug is supposed to do: converting existing Trikafta patients and reaching roughly 150 newly eligible U.S. patients with rarer CFTR mutations. Sales hit $210 million in the first half of 2025 and climbed to around $247 million in the third quarter, with Vertex citing a strong European rollout as well. It's now the clearest financial success among the class of 2025.
2. Datroway (Daiichi Sankyo / AstraZeneca) — the second approval landed
Datopotamab deruxtecan already had one 2025 approval in hand (HR-positive, HER2-negative breast cancer, January 2025) when it made this list. The bigger prize was lung cancer, where earlier trial setbacks had forced a strategic retreat to a narrower EGFR-mutated patient population. On June 23, 2025, the FDA granted accelerated approval in that subgroup, based on a 45% response rate in previously treated patients — making Datroway the first TROP2-directed therapy approved for lung cancer in the U.S. and validating Evaluate's decision to keep it on the list for a second straight year.
3. Journavx (Vertex) — approved, but the slowest of Vertex's two 2025 launches
Journavx's January 2025 approval as the first novel non-opioid pain mechanism in decades generated enormous attention, but prescription uptake proved much slower than Wall Street expected. The drug produced roughly $33 million in cumulative sales through the third quarter of 2025 — far short of a $110 million full-year estimate some analysts had floated — as payer coverage and physician familiarity built more gradually than for a typical acute-pain prescription. Vertex maintains the trajectory is improving into its second year on the market.
4. Myqorzo / aficamten (Cytokinetics) — a later, but real, approval
After Novartis's acquisition talks with Cytokinetics collapsed in early 2025, the biotech pressed ahead solo. The FDA extended its review to allow a fuller look at the drug's risk mitigation program, pushing the decision from a September 26, 2025 target to December 19, 2025. Approval finally arrived under the brand name Myqorzo, positioning Cytokinetics for its first-ever commercial launch in 2026 against Bristol Myers Squibb's incumbent Camzyos.
5. Brinsupri / brensocatib (Insmed) — the biotech breakout of the year
Insmed's brensocatib became the first FDA-approved treatment for non-cystic fibrosis bronchiectasis on August 12, 2025, branded Brinsupri, based on the pivotal ASPEN trial's roughly 20% reduction in exacerbations. It generated $28.1 million in revenue in its very first partial quarter on the market, and regulatory filings are now under review in the EU, U.K., and Japan for expected 2026 international launches — arguably the cleanest execution story among all 10 drugs on the original list.
6. Mazdutide (Innovent / Eli Lilly) — a China story, not yet a U.S. one
Innovent's dual GCG/GLP-1 agonist won NMPA approval for chronic weight management on June 27, 2025, then a second Chinese approval for type 2 diabetes glycemic control that September — making it the world's first dual glucagon/GLP-1 agonist cleared for either use, marketed in China as Sineipasy. Eli Lilly, which holds mazdutide's rights everywhere outside China, has not filed for U.S. approval; the drug's near-term commercial story remains confined to the Chinese incretin market, where it now competes directly with Novo Nordisk's and Lilly's own franchises.
7. Tolebrutinib (Sanofi) — the list's biggest miss
This was the most dramatic reversal of the group. Tolebrutinib carried a breakthrough therapy designation and positive phase 3 data (the HERCULES trial) showing a 31% delay in disability progression for non-relapsing secondary progressive MS. After the FDA twice pushed back its decision date, the agency issued a complete response letter on December 24, 2025 — declining to approve the drug in its submitted form and reportedly reversing signals it had given Sanofi earlier in the review. Sanofi called the decision "a significant and meaningful change in direction" from prior FDA feedback and says it's working toward a resubmission path in 2026.
8. Exdensur / depemokimab (GSK) — a twice-yearly asthma biologic arrives
GSK's long-acting IL-5 blocker won FDA approval in 2025 under the brand name Exdensur, for patients 12 and older with severe eosinophilic asthma. Its twice-a-year dosing schedule — versus the two-to-four-week schedules of Dupixent, Xolair, and GSK's own Nucala — was the central selling point GSK previewed at JPMorgan's 2025 healthcare conference, and the approval keeps that promise intact heading into 2026.
9. Penmenvy (GSK) — on schedule, on Valentine's Day
GSK's five-in-one meningococcal vaccine won approval on February 14, 2025 for ages 10 through 25, becoming the second pentavalent MenABCWY shot after Pfizer's Penbraya. The launch proceeded largely as GSK had outlined at JPMorgan, with the ACIP weighing in on recommended use shortly after approval.
10. Imaavy / nipocalimab (J&J) — one approval became two
J&J's FcRn blocker won its first approval on April 29, 2025, for generalized myasthenia gravis, as the company had hoped — and then kept going. In August 2026, Imaavy picked up a second approval as the first-ever treatment for warm autoimmune hemolytic anemia, giving J&J the broadest label of any FcRn-blocking antibody on the market and validating its "pipeline in a pathway" bet on the mechanism across multiple autoimmune diseases.
2025's Patent Cliffs — What Actually Happened
The 2025 patent-cliff list looked, at the time, like the industry's biggest single-year exposure since AbbVie's Humira cliff in 2023 — led by J&J's Stelara at $6.72 billion in 2024 U.S. sales. A year on, most of the erosion arrived on schedule. One drug (Entresto) lost its legal fight far sooner than its manufacturer hoped; one (Simponi) unexpectedly dodged the cliff altogether — for now.
| Drug | Company | 2024 U.S. sales | What actually happened |
|---|---|---|---|
| Stelara | Johnson & Johnson | $6.72B | As expected — sales down ~40% through 9 months of 2025 |
| Eylea | Regeneron | $4.77B | As expected — Pavblu leads a slow-building biosimilar field |
| Prolia / Xgeva | Amgen | $4.39B | As expected — Sandoz and Celltrion biosimilars launched on schedule |
| Entresto | Novartis | $4.05B | Worse than expected — generics arrived July 2025, ~16 months early |
| Soliris | AstraZeneca | $1.52B | As expected — Bkemv and Epysqli both launched in 2025 |
| Promacta | Novartis | $1.18B | Slightly slower — broad generic entry now tracking to early 2026 |
| Simponi / Simponi Aria | Johnson & Johnson | $1.08B | Better than expected — lead biosimilar hit an FDA rejection |
| Tysabri | Biogen | $920M | As expected — Tyruko finally launched after years of delay |
| Tasigna | Novartis | $848M | As expected — generics moved in around mid-2025 |
| Brilinta | AstraZeneca | $751M | As expected — generics launched around the May 9, 2025 date |
Stelara: the cliff arrived, but J&J's succession plan worked
Amgen's Wezlana became the first Stelara biosimilar to launch, on January 1, 2025, followed through the year by Alvotech/Teva, Sandoz/Samsung Bioepis, Celltrion, and others. Global Stelara sales fell roughly 40% over the first nine months of 2025 — a decline J&J had explicitly modeled on Humira's post-biosimilar trajectory. What's notable is what didn't happen: J&J's overall Innovative Medicine sales kept growing anyway, as Tremfya, Darzalex, and its oncology portfolio more than filled the gap, a considerably smoother transition than many analysts expected for a drug that had represented roughly a fifth of the unit's revenue.
Entresto: Novartis lost the fight it had been winning
This is the year's biggest surprise on the cliff side. Novartis spent early 2025 looking like the rare company that could hold off generics past its patent's nominal expiration — a Federal Circuit ruling in January 2025 had upheld a key Entresto patent, and the company won a temporary injunction against generic maker MSN Pharmaceuticals as late as mid-July. But on July 22, 2025, the Federal Circuit lifted that injunction, and generic sacubitril-valsartan from MSN and others launched within days — more than a year before the November 2026 date Novartis had been defending in court. It's a reminder that patent litigation outcomes can swing sharply and quickly, even for companies that appear to be winning.
Simponi: the drug that dodged its own cliff
J&J's golimumab franchise is the mirror image of Entresto. The lead biosimilar contender, Alvotech and Teva's AVT05, looked on track for a fourth-quarter 2025 FDA decision — until the agency issued a complete response letter in November 2025 over manufacturing concerns at Alvotech's Iceland facility. A second contender, Bio-Thera's biosimilar partnered with Accord BioPharma, is now tied up in a J&J patent infringement suit filed in early 2026. The upshot: Simponi never faced the biosimilar erosion the original 2025 forecast anticipated, and — as covered below — it reappears on Fierce Pharma's 2026 exclusivity-loss list, a rare instance of a drug getting a second bite at the patent-cliff apple.
Top 10 Most Anticipated Drug Launches of 2026
Evaluate's 2026 preview, published via Fierce Pharma in February 2026, projects the year's top 10 launches will generate a combined $45.9 billion in annual sales by 2032 — more than 50% above 2025's already-record forecast. The jump is driven almost entirely by the obesity and type 2 diabetes category: the top two drugs alone are projected to out-earn the entirety of 2025's top 10 combined.
1. CagriSema — Novo Nordisk
Indication: Obesity and type 2 diabetes | 2032 sales estimate: $17.2 billion
CagriSema combines 2.4 mg of semaglutide — the active ingredient in Wegovy and Ozempic — with the long-acting amylin analogue cagrilintide, and posted average weight loss of 22.7% in trials. Novo Nordisk filed with the FDA in late 2025 and is hoping for approval and a launch before year-end 2026, with additional trial data covering sleep apnea and cardiovascular disease informing the label the company ultimately seeks.
2. Orforglipron — Eli Lilly
Indication: Obesity and type 2 diabetes | 2032 sales estimate: $11.8 billion
Lilly's oral GLP-1 receptor agonist opens what analysts are calling round two of the obesity-drug war: unlike injectable peptide competitors, orforglipron is a small molecule, which should make it markedly cheaper and easier to manufacture at scale — a meaningful advantage for reaching large, price-sensitive markets like India, Brazil, and China. FDA approval is expected in the second quarter of 2026.
3. Anito-cel — Gilead Sciences / Arcellx
Indication: Multiple myeloma | 2032 sales estimate: $2.5 billion
This CAR-T cell therapy is positioning itself as a direct challenger to J&J's Carvykti, backed by a 74% complete response rate and 88% overall survival at 18 months in heavily pretreated patients presented at a recent hematology conference. A U.S. launch is expected in the second half of 2026.
4. Brepocitinib — Roivant Sciences
Indication: Dermatomyositis | 2032 sales estimate: $2.3 billion
Roivant licensed this TYK2/JAK1 inhibitor from Pfizer and is betting on rare-disease positioning: positive phase 3 results in dermatomyositis, a rare autoimmune muscle disease with few good options, have analysts calling it a likely best-in-class replacement for poorly accessible off-label treatments.
5. Icotrokinra (Icotyde) — Johnson & Johnson / Protagonist
Indication: Plaque psoriasis | 2032 sales estimate: $2.2 billion
Icotrokinra is the first targeted oral peptide designed to block the interleukin-23 receptor, and J&J is aiming it squarely at Bristol Myers Squibb's oral psoriasis leader Sotyktu, which it reportedly outperformed in a head-to-head phase 3 trial. J&J has signaled plans to pursue psoriatic arthritis and inflammatory bowel disease indications after the initial psoriasis launch.
6. Gedatolisib — Celcuity
Indication: HR-positive, HER2-negative breast cancer | 2032 sales estimate: $2.1 billion
Celcuity picked up this pan-PI3K/mTOR inhibitor from Pfizer for a modest upfront sum and has since built it into one of the year's more closely watched independent launches: combined with Faslodex, gedatolisib significantly extended progression-free survival in phase 3 testing, and Celcuity is preparing to commercialize the drug itself in the U.S. pending an FDA decision this year.
7. Ulixacaltamide — Praxis Precision Medicines
Indication: Essential tremor | 2032 sales estimate: $2.1 billion
An estimated 10 million Americans live with essential tremor, yet only one drug (propranolol) is currently approved, and it doesn't work for everyone. Ulixacaltamide, a T-type calcium channel blocker, rebounded from an early phase 2 setback to post two successful phase 3 trials, earning breakthrough therapy designation and an FDA filing in mid-February 2026.
8. Baxdrostat — AstraZeneca
Indication: Treatment-resistant hypertension | 2032 sales estimate: $2.0 billion
Acquired via AstraZeneca's $1.8 billion purchase of CinCor Pharma, this aldosterone synthase inhibitor is under FDA priority review with a decision expected in the second quarter of 2026. AstraZeneca is expected to lean on its large commercial infrastructure to get ahead of its main rival, Mineralys Therapeutics.
9. Camizestrant — AstraZeneca
Indication: HR-positive breast cancer | 2032 sales estimate: $2.0 billion
AstraZeneca's second entry on the list is a next-generation oral selective estrogen receptor degrader (SERD). In trials, switching patients to camizestrant when an ESR1 mutation emerged nearly doubled median progression-free survival compared with standard therapy — data AstraZeneca is positioning as a new backbone for endocrine breast-cancer treatment.
10. Atacicept — Vera Therapeutics
Indication: IgA nephropathy | 2032 sales estimate: $1.7 billion
This APRIL/BAFF-inhibiting fusion protein has a July 2026 PDUFA date and enters a market already home to Otsuka's Voyxact, with Vertex's povetacicept also advancing through late-stage trials. Analysts point to atacicept's low observed rate of anti-drug antibody formation in early studies as its main differentiator in what's expected to become a three-way market split.
Drugs Losing U.S. Exclusivity in 2026
Fierce Pharma's 2026 exclusivity report, published March 16, 2026, again lists 10 drugs, spanning Roche, Bristol Myers Squibb, Johnson & Johnson, Merck & Co., Merck KGaA, Takeda, UCB, and Pfizer. The five largest by U.S. sales are detailed below; as with Simponi's surprise reappearance from the 2025 list, this year's list is a reminder that "losing exclusivity" and "facing generic competition" aren't always the same year.
| Drug | Company | 2025 U.S. sales | Status as of early 2026 |
|---|---|---|---|
| Xolair (omalizumab) | Roche | $3.7B | Interchangeable biosimilar Omlyclo approved; market entry expected by Sept. 1, 2026 |
| Pomalyst (pomalidomide) | Bristol Myers Squibb | $2.34B | Already eroding — 6 generics approved, 4 selling at ~23% below brand price |
| Opsumit (macitentan) | Johnson & Johnson | $1.63B | 5 generics approved since 2023, none yet marketed |
| Januvia / Janumet (sitagliptin) | Merck & Co. | $1.27B | Lost exclusivity May 2026 (Janumet XR, July 2026); generics cleared to follow |
| Simponi (golimumab) | Johnson & Johnson | $1.19B | Back for a second year — lead biosimilar still stalled (see above) |
Xolair: a two-decade run finally meets a biosimilar
Roche's allergy and asthma biologic lost its U.S. patent protection in November 2025, and Celltrion's Omlyclo has since become the first FDA-approved biosimilar across all four of Xolair's indications, with an interchangeable designation that lets pharmacists substitute it without a new prescription. Market entry is expected on or before September 1, 2026. Xolair's wholesale acquisition cost currently ranges from roughly $1,400 to over $2,800 per dose depending on strength; no price has yet been announced for Omlyclo.
Pomalyst: the fastest-moving generic entry on the list
Bristol Myers Squibb's multiple myeloma drug is already facing real competition — six generic makers have FDA approval, four of them actively selling, at prices roughly 23% below Pomalyst's list price of about $24,500 for a 21-capsule supply. Expect that discount to widen as more of the approved generics reach pharmacy shelves through the rest of 2026.
Simponi, again: a second consecutive reprieve
Golimumab's continued presence on this list — for the second year running — is arguably the most interesting story of the 2026 cliff report. The Alvotech/Teva biosimilar's manufacturing-related rejection and the ongoing patent suit against the Bio-Thera/Accord contender mean J&J has now avoided direct U.S. biosimilar competition on Simponi for at least two additional years beyond its original patent expiration, even as the drug's composition-of-matter protection lapsed back in 2024.
FAQ
Did all of 2025's most-anticipated drugs get FDA approval?
No. Eight of the 10 reached the U.S. market in 2025, one (Sanofi's tolebrutinib) received a complete response letter in December 2025, and one (Innovent's mazdutide) has so far launched only in China, with no U.S. filing yet.
Which 2025 patent-cliff prediction was most wrong?
Entresto, in the direction of more erosion than expected: Novartis lost a Federal Circuit appeal in July 2025 and saw generics launch more than a year before the date it had been defending in court. Simponi was wrong in the opposite direction — it avoided biosimilar competition entirely in 2025 after its lead rival's manufacturing problems.
What is the biggest expected drug launch of 2026?
Novo Nordisk's CagriSema, a combination of semaglutide and cagrilintide for obesity and type 2 diabetes, with a projected $17.2 billion in annual sales by 2032 — more than double last year's top-ranked drug.
What is the biggest drug losing patent exclusivity in 2026?
Roche's Xolair (omalizumab), which had $3.7 billion in 2025 U.S. sales and lost patent protection in November 2025, with the first interchangeable biosimilar expected on the market by September 2026.
Why is Simponi on the exclusivity-loss list two years in a row?
Simponi's core patent expired in 2024, but its would-be biosimilar competitors have each hit separate roadblocks — a manufacturing-related FDA rejection for one, ongoing patent litigation for the other — so J&J has continued selling golimumab without direct biosimilar competition well past the date most forecasts expected.
Ask Your AI Assistant
This page is built to answer follow-up questions directly. If you're reading this via Claude, ChatGPT, Gemini, or Perplexity, try one of these:
- Claude / ChatGPT: "Compare Journavx's actual 2025 sales to what analysts originally projected, and explain why the launch was slower."
- Gemini: "Build a table of the 2026 patent cliff drugs by company, with expected generic entry dates."
- Perplexity: "What happened with Sanofi's tolebrutinib FDA rejection, and what's the path forward for 2026?"
Related Reading
- Largest Pharma Companies in the World (2026 Revenue Rankings)
- Top 10 Drugs by Worldwide Sales in 2025: Final Results and the 2026 Outlook
- Top Cancer Drug Companies (2026 Update): Leaders by Revenue, Pipeline, and Growth
- Top 10 Pharma Companies by R&D Spend
Disclosure: This article is for informational and journalistic purposes only and is not financial, investment, or medical advice. Sales figures, approval dates, and forecasts are drawn from company disclosures, SEC filings, and industry reporting (Evaluate, Fierce Pharma, and others) current as of publication and are subject to change. One Day Advisor may earn a commission on qualifying purchases through select affiliate links elsewhere on this site, including The Wellness Company (code ONEDAYMD) and Amazon Associates; no affiliate links appear in this specific article.
Sources include Fierce Pharma's "Top 10 most anticipated drug launches" and "Top 10 drugs losing US exclusivity" special reports (2025 and 2026 editions), Evaluate Ltd., company press releases and SEC filings (Vertex, Insmed, Cytokinetics, Sanofi, GSK, Johnson & Johnson, Novartis, AstraZeneca, Innovent, Roche, Bristol Myers Squibb, Merck), and Optum Rx's 2026 patent-expiration analysis.
.png)
Comments