Table 1. Pediatric Exclusivity Extensions Awarded by the US Food and Drug Administration for 54 Drugs, 2007-2012a.
| Drug | Brand Name | Manufacturer | Pediatric Exclusivity Grant Date | Year of Pediatric Exclusivity Extension |
|---|---|---|---|---|
| Eplerenone | Inspra | Pfizer | 10/24/2007 | 2019-2020b |
| Anastrozole | Arimidex | AstraZeneca | 11/14/2007 | 2009-2010 |
| Aripiprazole | Abilify | Otsuka (and Bristol-Myers Squibb) | 11/14/2007 | 2014-2015 |
| Divalproex | Depakote ER | Abbott | 12/14/2007 | 2008 |
| Zoledronic acid | Zometa | Novartis | 12/21/2007 | 2012-2013 |
| Technetium Tc99m sestamibi | Cardiolite | Bristol-Myers Squibb | 01/11/2008 | 2008 |
| Ezetimibe | Zetia | MSP Singapore | 02/14/2008 | 2016 |
| Valacyclovir | Valtrex | GlaxoSmithKline | 02/28/2008 | 2009 |
| Lopinavir/ritonavir | Kaletra | Abbott | 03/07/2008 | 2016 |
| Tipranavir | Aptivus | Boehringer Ingelheim | 03/07/2008 | 2019-2020b |
| Rocuronium | Zemuron | Organon | 04/03/2008 | 2011-2012 |
| Caspofungin | Cancidas | Merck & Co | 04/15/2008 | 2017b |
| Levetiracetam | Keppra | UCB Inc | 06/03/2008 | 2009 |
| Lansoprazole | Prevacid | Tap Pharmaceutical Products, Inc | 07/15/2008 | 2009 |
| Topiramate | Topamax | Ortho-McNeil-Janssen | 07/24/2008 | 2008-2009 |
| Valganciclovir | Valcyte | Hoffman-La Roche Inc | 07/24/2008 | 2015 |
| Albuterol | Ventolin HFA | GlaxoSmithKline | 08/27/2008 | 2026b |
| Bicalutamide | Casodex | AstraZeneca | 09/19/2008 | 2008-2009 |
| Almotriptan | Axert | Johnson & Johnson | 01/13/2009 | 2015 |
| Quetiapine | Seroquel | AstraZeneca | 01/23/2009 | 2012-2013 |
| Colesevelam | Welchol | Daiichi Sankyo | 02/17/2009 | 2022b |
| Pantoprazole | Protonix | Wyeth | 02/17/2009 | 2010-2011 |
| Risedronate | Actonel | Procter & Gamble | 04/24/2009 | 2013-2014 |
| Esomeprazole | Nexium | AstraZeneca | 05/01/2009 | 2015 |
| Gatifloxacin | Zymar | Allergan | 05/19/2009 | 2013 |
| Bivalirudin | Angiomax | The Medicines Company | 06/17/2009 | 2014-2015 |
| Rosuvastatin | Crestor | AstraZeneca | 07/07/2009 | 2016 |
| Candesartan | Atacand | AstraZeneca | 07/20/2009 | 2012 |
| Olopatadine | Patanol | Alcon | 08/12/2009 | 2015 |
| Levocetirizine | Xyzal | UCB Inc | 08/25/2009 | 2010 |
| Tamsulosin | Flomax | Boehringer Ingelheim | 09/17/2009 | 2009-2010 |
| Famciclovir | Famvir | Novartis | 09/21/2009 | 2010-2011 |
| Olmesartan | Benicar | Daiichi Sankyo | 10/07/2009 | 2016 |
| Docetaxel | Taxotere | Sanofi-Aventis | 03/17/2010 | 2010-2011 |
| Alfuzosin | Uroxatral | Sanofi-Aventis | 09/07/2010 | 2011 |
| Saquinavir | Fortovase | Hoffman-La Roche Inc | 10/26/2010 | 2019-2020b |
| Nitric oxide | INOmax | INO Therapeutics | 11/02/2010 | 2031b |
| Pemetrexed | Alimta | Eli Lilly | 12/03/2010 | 2016-2017 |
| Loteprednol/tobramycin | Zylet | Bausch & Lomb | 12/28/2010 | 2012 |
| Paliperidone | Invega | Ortho-McNeil-Janssen | 01/05/2011 | 2015 |
| Clopidogrel | Plavix | Sanofi-Aventis | 01/20/2011 | 2011-2012 |
| Fulvestrant | Faslodex | AstraZeneca | 02/01/2011 | 2021b |
| Ixabepilone | Ixempra | Bristol-Myers Squibb | 04/05/2011 | 2024-2025b |
| Darunavir | Prezista | Tibotec | 06/07/2011 | 2024b |
| Tenofovir | Viread | Gilead | 09/06/2011 | 2017-2018b |
| Rizatriptan | Maxalt | Merck | 09/20/2011 | 2012 |
| Fosamprenavir | Lexiva | ViiV | 01/10/2012 | 2015 |
| Sildenafil | Revatio | Pfizer | 02/09/2012 | 2017b |
| Temsirolimus | Torisel | Pfizer | 02/28/2012 | 2032b |
| Bendamustine | Treanda | Cephalon | 05/24/2012 | 2030-2031b |
| Eszopiclone | Lunesta | Sunovion | 06/29/2012 | 2014 |
| Duloxetine | Cymbalta | Eli Lilly | 07/02/2012 | 2013 |
| Everolimus | Afinitor | Novartis | 07/10/2012 | 2019-2020b |
| Rabeprazole | Aciphex | Eisai | 12/04/2012 | 2013 |
a
Drugs arranged by pediatric exclusivity award date. Drugs with multiple years in the Year of Pediatric Exclusivity Extension column reflect a 6-month window that spans 2 calendar years.
b
Denotes drugs for which pediatric exclusivity had not completed by June 30, 2017, based on FDA Orange Book queries in January 2017. These dates may be subject to change due to future patent challenges, litigation, or settlements. For more details see eTable 5 in the Supplement.