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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. 


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.
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