How many drugs are losing patent protection in 2031?

Drug Landscape tracks 50 marketed drugs with at least one patent expiring in 2031, 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 2026-05-14 · How we verify

2031 Pharmaceutical Patent Cliff

50 marketed drugs with patents expiring in 2031, joined to sponsor + therapeutic area + drug class. Forward-looking forecast. Sourced from FDA Orange Book + USPTO Patent Public Search.

50 drugs 141 patents 10 therapeutic areas Forward-looking

By therapeutic area

Oncology (21)

2031-01-20 — Mitozytrex · Kyowa Kirin Co., Ltd. · Alkylating Drug [EPC] · Formulation
2031-02-05 — Lupron · Accord Healthcare S.L.U. · Gonadotropin Releasing Hormone Receptor Agonist
2031-02-05 — Leuprolide Acetate · Pfizer · leuprorelin
2031-02-14 — Flonase · GSK (GlaxoSmithKline) · Inhaled/intranasal corticosteroid · Formulation
2031-02-25 — Sandimmune · Novartis · Calcineurin Inhibitor Immunosuppressant [EPC]
2031-02-27 — TELOTRISTAT ETIPRATE · Serotonin Synthesis Inhibitor · Compound
2031-03-13 — Kisqali · Novartis · Kinase Inhibitor
2031-04-10 — Viekira Pak (Copackaged) · AbbVie · Hepatitis C Virus Non-Nucleoside NS5B Palm Polymerase Inhibitor
2031-04-27 — Jevtana Kit · Accord Hlthcare · Microtubule Inhibitor · Compound
2031-05-04 — Zepatier · Merck & Co. · Hepatitis C Virus NS5A Inhibitor [EPC]
2031-05-06 — Mavyret · AbbVie · Hepatitis C Virus NS5A Inhibitor [EPC]
2031-05-27 — Trexall · Generic (originally Lederle Laboratories) · Antifolate, DMARD · Formulation
2031-06-27 — Venclexta · AbbVie · BCL-2 Inhibitor [EPC]
2031-07-04 — Mektovi · Pfizer
2031-07-18 — Cometriq · Exelixis · Kinase Inhibitor
2031-07-31 — Xyosted (Autoinjector) · Endo · Androgen
2031-08-07 — Taxotere · Sanofi · Microtubule Inhibitor [EPC] · Formulation
2031-09-09 — Akynzeo · Helsinn Hlthcare · Serotonin-3 Receptor Antagonist [EPC]
2031-10-03 — Elocon · Merck & Co. · Corticosteroid · Method of Use
2031-10-20 — Talzenna · Pfizer · Poly(ADP-Ribose) Polymerase Inhibitor
2031-11-02 — Ultravate · Ranbaxy · ulobetasol propionate

Metabolic (8)

2031-03-05 — Tradjenta · Boehringer Ingelheim · Dipeptidyl Peptidase 4 Inhibitor [EPC]
2031-03-17 — Cuvposa · Shionogi · Anticholinergic
2031-03-29 — Sodium Thiosulfate · Us Army · sodium thiosulfate · Compound
2031-04-04 — Byetta · AstraZeneca · GLP-1 Receptor Agonist [EPC]
2031-05-18 — Beconase Aq · Corticosteroid
2031-06-07 — Keppra · Generic (originally UCB Pharma) · Antiepileptic agent · Formulation
2031-07-21 — Acetadote · Bristol-Myers Squibb · Antidote · Method of Use
2031-12-05 — Ozempic · Novo Nordisk · GLP-1 Receptor Agonist [EPC]

Neuroscience (6)

2031-05-31 — Risperdal · Johnson & Johnson (Janssen) · Atypical Antipsychotic [EPC] · Method of Use
2031-06-06 — Subutex · Purdue Pharma Lp · Partial Opioid Agonist · Method of Use
2031-07-11 — Abilify · Generic (originally Otsuka/BMS) · Third-generation antipsychotic (D2 partial agonist) · Formulation
2031-07-19 — Imitrex · GSK · Serotonin-1b and Serotonin-1d Receptor Agonist · Formulation
2031-08-23 — Lybalvi · Alkermes Inc · Atypical Antipsychotic [EPC]
2031-09-08 — Catapres-Tts-1 · Lavipharm · Central alpha-2 Adrenergic Agonist · Formulation

Cardiovascular (4)

2031-01-20 — Pradaxa · Boehringer Ingelheim · Direct thrombin inhibitor
2031-05-18 — Proventil · Merck & Co. · beta2-Adrenergic Agonist
2031-07-01 — Edarbi · Arbor Pharms Ireland · Angiotensin 2 Receptor Blocker
2031-07-01 — Combipres · University Hospital Birmingham · Thiazide-like Diuretic

Immunology (3)

2031-02-22 — Acetaminophen · Polymedica · acetaminophen
2031-02-25 — Sandimmune · Novartis AG (originally Sandoz) · Calcineurin inhibitor (immunosuppressant) · Formulation
2031-09-07 — Pulmicort Respules · AstraZeneca K.K. · Corticosteroid [EPC] · Formulation

Respiratory (3)

2031-03-25 — Symdeko (Copackaged) · Vertex Pharms
2031-03-25 — Trikafta (Copackaged) · Vertex Pharms Inc
2031-04-11 — Breo Ellipta · Glaxo Grp Ltd · beta2-Adrenergic Agonist

Infectious Disease (2)

2031-08-08 — Vabomere · Rempex Pharms Inc · beta Lactamase Inhibitor [EPC]
2031-08-12 — Avycaz · Cerexa Inc · beta Lactamase Inhibitor [EPC]

Pain (1)

2031-02-28 — Naloxone Hydrochloride · Pfizer Inc. · Mixed opioid agonist-antagonist with opioid antagonist · Formulation

Hematology (1)

2031-05-26 — Livmarli · Mirum Pharma Inc · Ileal Bile Acid Transporter Inhibitor