Generics manufacturers have been waiting for something of the same scale as the 2011-2016 Patent Cliff, when the expiration of multiple blockbuster patents coincided, unlocking hundreds of billions in value. Watching drugs going off-patent in 2020-2026, it looks like we are entering a period of increased opportunities and potential.
Blockbuster drugs that are already on their way to becoming generics include diabetes drug Sitagliptin (traded as Januvia), immunology treatment Cyclosporine (traded as Restasis), multiple sclerosis treatment Dimethyl fumarate (marketed as Tecfidera), and many more.
After cross-referencing publically available data sources, we came up with a list of more than 50 drugs coming off-patent by 2026 and added annual sales figures to illustrate the market size. Generic drugs developed on the basis of these off-patent drugs have immense potential to help patients across the globe. In the wake of a recession, driving healthcare costs will be on the agenda of many governments.
Main therapeutic indication |
Generic name, trade name |
Company | Sales, bil $ | Sales period |
Patent expiration |
Autoimmune disorders | Pirfenidone Esbriet |
Roche | 1.1 | 2019 | 2026 |
Cardiovascular diseases | Ticagrelor Brilinta, Brilique |
AstraZeneca | 1.321 | 2018 | 2021 |
Cardiovascular diseases | Nebivolol Bystolic, Byvalson |
Allergan | 0.586 | 2018 | 2021 |
Cardiovascular diseases | Dabigatran etexilate Pradaxa |
Boehringer Ingelheim | 1.679 | 2018 | 2021-2022 |
Cardiovascular diseases | Macitentan Opsumit |
Johnson&Johnson | 1.3 | 2019 | 2025 |
Cardiovascular diseases | Sacubitril + Valsartan Entresto |
Novartis | 1.7 | 2019 | 2026 |
Cardiovascular diseases | Rivaroxaban Xarelto |
Bayer | 4.103 | 2018 | 2021-2024 |
Diabetes | Exenatide Bydureon |
AstraZeneca | 0.584 | 2018 | 2020 |
Diabetes | Metformin + Sitagliptin Janumet |
Merck & Co. | 2.228 | 2018 | 2023 |
Diabetes | Vildagliptin Galvus |
Novartis | 1.3 | 2019 | 2024 |
Diabetes | Linagliptin Trajenta, Jentadueto |
Boehringer Ingelheim | 1.7 | 2019 | 2025 |
Diabetes | Dapagliflozin Farxiga, Forxiga |
AstraZeneca | 1.5 | 2019 | 2025 |
Diabetes | Sitagliptin Januvia |
Merck & Co. | 3.5 | 2019 | 2022-2026 |
Gastrointestinal disorders | Dexlansoprazole Dexilant |
Takeda | 0.617 | 2018 | 2020 |
Gastrointestinal disorders | Lubiprostone Amitiza |
Takeda | 0.295 | 2018 | 2021 |
Immunology (organ transplant, arthritis, etc.) | Cyclosporine Restasis |
Allergan | 1.262 | 2018 | 2022 |
Immunology (organ transplant, arthritis, etc.) | Tofacitinib citrate Xeljanz |
Pfizer | 1.9 | 2019 | 2025 |
Infectious diseases (HIV, hepatitis, etc.) | Emtricitabine + Tenofovir disoproxil fumarate Truvada |
Gilead | 2.997 | 2018 | 2021 |
Infectious diseases (HIV, hepatitis, etc.) | Efavirenz + Emtricitabine + Tenofovir Disoproxil fumarate Atripla |
Gilead | 1.206 | 2018 | 2021 |
Infectious diseases (HIV, hepatitis, etc.) | Maraviroc. Selzentry |
GlaxoSmithKline | 0.153 | 2018 | 2021-2022 |
Infectious diseases (HIV, hepatitis, etc.) | Emtricitabine + Tenofovir alafenamide Descovy |
Gilead | 1.5 | 2019 | 2026 |
Infectious diseases (HIV, hepatitis, etc.) | Emtricitabine + Rilpivirine hydrochloride + Tenofovir alafenamide fumarate. Odefsey |
Gilead | 1.7 | 2019 | 2026 |
Neurological, mental disorders | Asenapine Saphris |
Allergan | 0.14 | 2018 | 2020 |
Neurological, mental disorders | Memantine hydrochloride Namenda XR |
Allergan | 0.071 | 2018 | 2020 |
Neurological, mental disorders | Paliperidone palmitate Invega Sustenna, Xeplion, Trinza, Trevicta |
Johnson & Johnson | 2.928 | 2018 | 2022 |
Neurological, mental disorders | Varenicline Chantix, Champix |
Pfizer | 1.084 | 2018 | 2020-2022 |
Neurological, mental disorders | Dimethyl fumarate Tecfidera |
Biogen | 4.274 | 2018 | 2023 |
Neurological, mental disorders | Teriflunomide Aubagio |
Sanofi | 1.861 | 2018 | 2023 |
Neurological, mental disorders | Lurasidone Latuda |
Dainippon Sumitomo | 1.648 | 2018 | 2023 |
Neurological, mental disorders | Sodium oxybate Xyrem |
Jazz Pharms | 1.6 | 2019 | 2023 |
Neurological, mental disorders | Lisdexamfetamine. Vyvanse |
Takeda | 2.2 | 2019 | 2024 |
Neurological, mental disorders | Sugammadex Bridion |
Merck & Co. | 1.1 | 2019 | 2026 |
Neurological, mental disorders | Lacosamide Vimpat |
UCB | 1.4 | 2019 | 2022-2024 |
Oncology | Dasatinib Sprycel |
Bristol Myers Squibb | 2 | 2018 | 2020 |
Oncology | Axitinib Inlyta |
Pfizer | 0.297 | 2018 | 2020 |
Oncology | Abiraterone acetate Zytiga |
Johnson & Johnson | 3.498 | 2018 | 2021 |
Oncology | Sunitinib malate Sutent |
Pfizer | 1.049 | 2018 | 2021 |
Oncology | Erlotinib Tarceva |
Roche | 0.543 | 2018 | 2021 |
Oncology | Lenalidomide Revlimid |
Celgene | 9.685 | 2018 | 2022 |
Oncology | Pemetrexed Alimta |
Eli Lilly | 2.133 | 2018 | 2022 |
Oncology | Bortezomib Velcade |
Takeda | 1.167 | 2018 | 2022 |
Oncology | Nilotinib Tasigna |
Novartis | 1.9 | 2019 | 2024 |
Oncology | Pomalidomide Pomalyst, Imnovid |
Celgene | 2.2 | 2019 | 2025 |
Oncology | Enzalutamide Xtandi |
Astellas | 2.95 | 2018 | 2026 |
Oncology | Bevacizumab Avastin |
Roche | 6.917 | 2018 | 2022-2023 |
Ophthalmology | Ranibizumab Lucentis |
Novartis | 2.046 | 2018 | 2021-2022 |
Renal disorders | Mirabegron Betanis, Myrbetriq, Betmiga |
Astellas | 1.287 | 2018 | 2022 |
Renal disorders | Vasopressin Vasostrict |
Endo Pharmaceuticals | 0.454 | 2018 | 2022 |
Respiratory disorders | Fluticasone furoate Avamys, Veramyst |
GlaxoSmithKline | 0.399 | 2018 | 2021 |
Respiratory disorders | Arformoterol Brovana |
Dainippon Sumitomo | 0.298 | 2018 | 2021 |
Respiratory disorders | Nintedanib Ofev |
Boehringer Ingelheim | 1.7 | 2019 | 2025 |
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Sources: 1) KPMG. Generics 2030. Three strategies to curb the downward spiral. 2020. 2) Drugs Coming Off Patent by 2022. https://pharmexcil.com/uploadfile/ufiles/2063002909_Offpatents.pdf. 3) Drugs going off patent in 2021. https://medcallrx.com/drugs-going-off-patent-in-2021/. 4) The top 10 drugs losing US exclusivity in 2022. https://www.fiercepharma.com/special-reports/top-10-drugs-losing-us-exclusivity-2022.