Approximate expected generic entry times for a selection of new drugs approved since 2000
In a recent study,[1] we developed a methodology for estimating first generic entry based on the expiration dates of manufacturers’ drug patents and two special exclusivity extensions made available to drug manufacturers under current law: “patent term restoration” and pediatric exclusivity. The methodology accurately predicted generic entry within a calendar quarter for 60% of products among a cohort of top-selling drugs.
To extend that project, we applied our methodology for determining the predicted date of generic entry to a more recent cohort of brand-name drugs to help policymakers and patients assess when potentially wasteful delays might be occurring. Originally published in JLME and updated in July 2018,[2] our results below are for small molecule drugs that were approved since 2000 with an active ingredient never before approved by the FDA with an approximate generic entry quarter occurring within the next five years. Note that the below approximations will be most accurate when markets are larger (e.g., are not drugs for rare diseases) and/or when there is not additional patent protection that extends beyond the expected quarter of generic entry. Further, the below approximations are subject to subsequent adjustments if written requests for pediatric studies occur in the future or if additional patents are added to the Orange Book. The below table will be updated quarterly to account for these changes as well as the addition of new drug approvals, new decisions on applications for patent term restoration extension periods, and new availability of generic drugs.
To extend that project, we applied our methodology for determining the predicted date of generic entry to a more recent cohort of brand-name drugs to help policymakers and patients assess when potentially wasteful delays might be occurring. Originally published in JLME and updated in July 2018,[2] our results below are for small molecule drugs that were approved since 2000 with an active ingredient never before approved by the FDA with an approximate generic entry quarter occurring within the next five years. Note that the below approximations will be most accurate when markets are larger (e.g., are not drugs for rare diseases) and/or when there is not additional patent protection that extends beyond the expected quarter of generic entry. Further, the below approximations are subject to subsequent adjustments if written requests for pediatric studies occur in the future or if additional patents are added to the Orange Book. The below table will be updated quarterly to account for these changes as well as the addition of new drug approvals, new decisions on applications for patent term restoration extension periods, and new availability of generic drugs.
| Active Ingredient | Trade Name | Approval Year | Expected Quarter of Generic Entry†| Last-Expiring Orange Book Patent (if later than expected) | Orphan Drug Exclusivity (ODE) |
|---|---|---|---|---|---|
| aliskiren | Tekturna | 2007 | 2019 Q1 | 2026 Q1 | |
| alogliptin | Nesina | 2013 | 2021 Q2 | 2029 Q2 | |
| anidulafungin | Eraxis | 2006 | 2020 Q1 | 2022 Q2 | |
| asenapine | Saphris | 2009 | 2020 Q4 | 2026 Q2 | |
| bepotastine | Bepreve | 2009 | 2019 Q3 | 2024 Q3 | |
| cabazitaxel | Jevtana Kit | 2010 | 2021 Q3 | 2030 Q4 | |
| ceftaroline | Teflaro | 2010 | 2022 Q2 | 2031 Q1 | |
| cholic acid | Cholbam | 2015 | 2022 Q1 | ODE | |
| clevidipine | Cleviprex | 2008 | 2021 Q1 | 2031 Q4 | |
| conivaptan | Vaprisol | 2005 | 2019 Q4 | ||
| dabigatran | Pradaxa | 2010 | 2021 Q4 | 2031 Q1 | |
| *dasatinib | Sprycel | 2006 | 2020 Q2 | 2026 Q1 | ODE |
| *deferasirox | Exjade | 2005 | 2019 Q2 | ODE | |
| deferiprone | Ferriprox | 2011 | 2021 Q2 | ODE | |
| degarelix acetate | Firmagon | 2008 | 2021 Q2 | 2032 Q2 | |
| difluprednate | Durezol | 2008 | 2019 Q4 | ||
| eltrombopag olamine | Promacta | 2008 | 2023 Q2 | 2027 Q3 | ODE |
| elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | Genvoya | 2015 | 2021 Q2 | 2032 Q3 | |
| eribulin mesylate | Halaven | 2010 | 2023 Q3 | ||
| *erlotinib | Tarceva | 2004 | 2019 Q2 | 2020 Q4 | |
| eslicarbazepine | Aptiom | 2013 | 2021 Q2 | 2032 Q3 | |
| etravirine | Intelence | 2008 | 2020 Q4 | ||
| everolimus | Afinitor | 2009 | 2020 Q1 | 2028 Q3 | |
| febuxostat | Uloric | 2009 | 2019 Q1 | 2031 Q3 | |
| fingolimod | Gilenya | 2010 | 2019 Q1 | 2027 Q2 | |
| icatibant acetate | Firazyr | 2011 | 2019 Q3 | ODE | |
| ingenol mebutate | Picato | 2012 | 2020 Q4 | 2033 Q2 | |
| insulin detemir | Levemir | 2005 | 2019 Q2 | 2032 Q3 | |
| ixabepilone | Ixempra Kit | 2007 | 2021 Q1 | 2024 Q3 | |
| lacosamide | Vimpat | 2008 | 2022 Q1 | ||
| lanreotide | Somatuline Depot | 2007 | 2020 Q1 | ODE | |
| lapatinib | Tykerb | 2007 | 2020 Q3 | 2029 Q3 | |
| lenalidomide | Revlimid | 2005 | 2019 Q4 | 2028 Q1 | ODE |
| liraglutide | Victoza | 2010 | 2022 Q3 | 2032 Q3 | |
| lisdexamfetamine dimesylate | Vyvanse | 2007 | 2023 Q1 | 2023 Q2 | |
| lomitapide | Juxtapid | 2012 | 2020 Q1 | 2027 Q3 | ODE |
| luliconazole | Luzu | 2013 | 2020 Q1 | 2034 Q2 | |
| lurasidone | Latuda | 2010 | 2019 Q1 | 2031 Q2 | |
| maraviroc | Selzentry | 2007 | 2021 Q3 | 2022 Q4 | |
| micafungin | Mycamine | 2005 | 2019 Q1 | 2021 Q1 | |
| mirabegron | Myrbetriq | 2012 | 2022 Q1 | 2023 Q4 | |
| *nebivolol | Bystolic | 2007 | 2021 Q4 | ||
| netupitant and palonosetron | Akynzeo | 2014 | 2019 Q4 | 2031 Q3 | |
| nilotinib hcl mononitrate | Tasigna | 2007 | 2023 Q3 | 2032 Q2 | ODE |
| omacetaxine | Synribo | 2012 | 2019 Q4 | 2026 Q4 | ODE |
| oritavancin diphosphate | Orbactiv | 2014 | 2020 Q4 | 2035 Q3 | |
| pazopanib hcl | Votrient | 2009 | 2023 Q4 | ||
| *pitavastatin | Livalo | 2009 | 2021 Q1 | 2024 Q1 | |
| posaconazole | Noxafil | 2006 | 2019 Q3 | 2022 Q2 | |
| pralatrexate | Folotyn | 2009 | 2022 Q3 | 2025 Q2 | ODE |
| pramlintide acetate | Symlin | 2005 | 2019 Q1 | ||
| raltegravir potassium | Isentress | 2007 | 2023 Q2 | 2030 Q4 | |
| *ramelteon | Rozerem | 2005 | 2019 Q3 | ||
| regorafenib | Stivarga | 2012 | 2022 Q2 | 2031 Q2 | |
| retapamulin | Altabax | 2007 | 2021 Q2 | 2027 Q1 | |
| roflumilast | Daliresp | 2011 | 2020 Q1 | 2024 Q1 | |
| rotigotine | Neupro | 2007 | 2021 Q1 | 2027 Q3 | |
| *rufinamide | Banzel | 2008 | 2023 Q2 | ODE | |
| saxagliptin | Onglyza | 2009 | 2023 Q3 | 2028 Q4 | |
| sinecatechins or kunecatechins | Veregen | 2006 | 2021 Q1 | 2026 Q4 | |
| *sodium oxybate | Xyrem | 2002 | 2019 Q4 | 2033 Q1 | ODE |
| *solifenacin | Vesicare | 2004 | 2019 Q2 | ||
| sorafenib tosylate | Nexavar | 2005 | 2020 Q1 | 2028 Q3 | ODE |
| spinosad | Natroba | 2011 | 2023 Q1 | 2023 Q3 | |
| sunitinib | Sutent | 2006 | 2021 Q1 | ||
| tafluprost | Zioptan | 2012 | 2022 Q4 | ||
| tasimelteon | Hetlioz | 2014 | 2021 Q1 | 2034 Q2 | ODE |
| teduglutide | Gattex | 2012 | 2020 Q2 | 2025 Q4 | ODE |
| telavancin | Vibativ | 2009 | 2023 Q3 | 2027 Q1 | |
| temsirolimus | Torisel | 2007 | 2019 Q3 | 2032 Q2 | ODE |
| tesamorelin acetate | Egrifta | 2010 | 2020 Q2 | 2023 Q3 | |
| tipranavir | Aptivus | 2005 | 2019 Q4 | ||
| tolvaptan | Samsca | 2009 | 2020 Q2 | 2026 Q3 | |
| vandetanib | Caprelsa | 2011 | 2022 Q2 | 2028 Q3 | ODE |
| varenicline tartrate | Chantix | 2006 | 2020 Q2 | 2022 Q3 | |
| vilazodone | Viibryd | 2011 | 2019 Q3 | 2022 Q2 |
* As of July 2018, the FDA had approved a generic application for this drug; however, no code was available for that product in the National Drug Code Registry, implying that marketing for that generic product has not yet begun.
† Prediction based on Beall-Darrow-Kesselheim model described in reference [1].
References:
[1] Beall, R.F., Darrow, J.J. and Kesselheim, A.S., 2018. A method for approximating future entry of generic drugs. Value in Health, 21(12), pp.1382-1389.
[2] Beall, R.F., Darrow, J.J. and Kesselheim, A.S., 2019. Approximating future generic entry for new drugs. Journal of Law, Medicine, and Ethics.
