How many drugs are losing patent protection in 2023?

Drug Landscape tracks 38 marketed drugs with at least one patent expiring in 2023, sourced from FDA Orange Book + USPTO Patent Public Search.

What is a patent cliff?

A patent cliff is the year a major branded drug loses primary patent protection, opening the market to generic or biosimilar entry. Originator revenue typically drops 30–80% within 24 months, depending on the drug class and the strength of secondary patents.

Are these forecasts accurate?

Patent expiry dates are deterministic — they're the listed expiry from the Orange Book or USPTO record. Generic / biosimilar entry timing depends on litigation outcomes, paragraph IV challenges, settlements, and exclusivity periods which can shift the practical "cliff" by months to years.

Last reviewed 2026-06-10 · How we verify

2023 Pharmaceutical Patent Cliff

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

38 marketed drugs with patents expiring in 2023, joined to sponsor + therapeutic area + drug class. Historical archive. Sourced from FDA Orange Book + USPTO Patent Public Search.

38 drugs 70 patents 13 therapeutic areas Historical

By therapeutic area

Oncology (8)

2023-03-13 — Koselugo · ASTRAZENECA LP · Kinase Inhibitor [EPC]
2023-03-13 — Mektovi · Pfizer
2023-03-17 — Akynzeo · Helsinn Hlthcare · Serotonin-3 Receptor Antagonist [EPC]
2023-07-18 — Carac · Spectrum Pharms · Nucleoside Metabolic Inhibitor
2023-07-25 — Torisel · Pfizer · temsirolimus
2023-10-15 — Lupron · Accord Healthcare S.L.U. · Gonadotropin Releasing Hormone Receptor Agonist
2023-10-15 — Leuprolide Acetate · Pfizer · leuprorelin
2023-12-09 — Taxol · Pfizer · Microtubule Inhibitor

Metabolic (8)

2023-03-14 — Zuragard · isopropanol
2023-04-09 — Byetta · AstraZeneca · GLP-1 Receptor Agonist [EPC]
2023-04-14 — Zosyn · Merck Sharp & Dohme B.V. · beta Lactamase Inhibitor
2023-04-15 — Aceon · Symplmed Pharms Llc · Angiotensin Converting Enzyme Inhibitor
2023-05-24 — Amphetamine Sulfate · UCB · Central Nervous System Stimulant
2023-06-30 — Ozempic · Novo Nordisk · GLP-1 Receptor Agonist [EPC]
2023-08-12 — Tradjenta · Boehringer Ingelheim · Dipeptidyl Peptidase 4 Inhibitor [EPC]
2023-08-20 — Cuvposa · Shionogi · Anticholinergic

Neuroscience (5)

2023-03-04 — Plegisol In Plastic Container · Pfizer · magnesium chloride
2023-06-01 — flunarizine and/or pregabalin · Taipei Veterans General Hospital, Taiwan · ["Calcium Channel Blocker", "Anticonvulsant"]
2023-07-30 — Phenergan Vc W/ Codeine · ANI Pharmaceuticals · Nonsteroidal Anti-inflammatory Drug [EPC]
2023-09-06 — Renacidin · Baxter · Anti-coagulant
2023-12-19 — Vyndaqel · Foldrx Pharms · tafamidis

Immunology (3)

2023-01-24 — Vizamyl · GE HealthCare · Radioactive Diagnostic Agent [EPC]
2023-02-28 — Norgesic · Endo · centrally acting muscle relaxant with anticholinergic properties
2023-06-01 — Fluvastatin, Tacrolimus, Mycophenolat Mofetil · University Hospital Schleswig-Holstein · ["Statins", "Immunosuppressants", "Immunosuppressants"]

Bone (3)

2023-03-06 — Fosamax · Merck And Co Inc · Vitamin D [EPC]
2023-05-06 — Boniva · Hoffmann La Roche · Bisphosphonate
2023-06-15 — Ortho-Novum 10/11-21 · Merck & Co. · Estrogen

Other (2)

2023-03-04 — Sodium Chloride · Pfizer · sodium chloride
2023-04-14 — Pipracil · Pfizer Inc. · Penicillin-class antibacterial with beta-lactamase inhibitor

Respiratory (2)

2023-03-23 — Breo Ellipta · Glaxo Grp Ltd · beta2-Adrenergic Agonist
2023-12-08 — Xopenex · Oak Pharms Inc · beta2-Adrenergic Agonist

Cardiovascular (2)

2023-05-06 — Proventil · Merck & Co. · beta2-Adrenergic Agonist
2023-06-14 — Pradaxa · Boehringer Ingelheim · Direct thrombin inhibitor

Gastroenterology (1)

2023-03-07 — Suprep Bowel Prep Kit · Nihon Pharmaceutical Co., Ltd.

Infectious Disease (1)

2023-04-14 — Piperacillin And Tazobactam · Pfizer · Penicillin-class antibacterial with beta-lactamase inhibitor

Nephrology (1)

2023-05-24 — Xelstrym · UCB · Central Nervous System Stimulant [EPC]

Dermatology (1)

2023-09-06 — Prismasol Bk 0/3.5 In Plastic Container · lactic acid

Pain (1)

2023-09-08 — Tri-Luma · Galderma Labs Lp · Melanin Synthesis Inhibitor [EPC]

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2023 patent expiries dataset (CSV / JSON)