Drugs with granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act

	A	B	C	D	E	F	G	H	I
1	INN	Original Brand name	Date of Exclusivity	Year of exclusivity	Sponsor	Original written request	Indication(s)	Indication(s) short	Notes written by the FDA

2	Imiquimod		12/13/2006	2006	3M		Molluscum contagiosum	Molluscum contagiosum
3	Remifentanil		3/15/2000	2000	Abbott		Anesthetic	Anesthetic
4	Sevoflurane		8/2/2000	2000	Abbott		Anesthetic	Anesthetic
5	Calcitriol		2/16/2001	2001	Abbott		Hypocalcemia management in patients on hemodialysis	Hypocalcemia
6	Paricalcitol		12/8/2003	2003	Abbott		End Stage Renal Disease	Renal disease
7	Sibutramine		10/6/2004	2004	Abbott		Pediatric Obesity	Obesity
8	Ritonavir	Norvir	6/14/2005	2005	Abbott		HIV-1 Infection	HIV
9	Valproic acid		12/14/2007	2007	Abbott		Migraine, Bipolar disorder, Epilepsy	Migraine, Bipolar disorder, Epilepsy
10	Lopinavir/Ritonavir	Kaletra	3/7/2008	2008	Abbott	https://www.fda.gov/media/71284/download	HIV-1 Infection	HIV	This is the first period of Pediatric Exclusivity for lopinavir and a second period for ritonavir.
11	Nelfinavir		9/4/2003	2003	Agouron		HIV-1 Infection	HIV
12	Ciprofloxacin Ophth		1/10/2003	2003	Alcon		Bacterial conjunctivitis	Conjunctivitis
13	Moxifloxacin Ophth		1/10/2003	2003	Alcon		Bacterial conjunctivitis	Conjunctivitis
14	Brinzolamide		6/28/2006	2006	Alcon		Elevated intraocular pressure	Intraocular pressure
15	Levobetaxolol		6/28/2006	2006	Alcon		Elevated intraocular pressure	Intraocular pressure
16	Timolol		2/28/2007	2007	Alcon		Elevated intraocular pressure	Intraocular pressure
17	Olopatadine		8/12/2009	2009	Alcon	https://www.fda.gov/media/79810/download	Allergic rhinitis	Rhinitis
18	Difluprednate		3/21/2013	2013	Alcon	https://www.fda.gov/media/85687/download	Post-operative inflammation following cataract surgery	Post-operative inflammation
19	Finafloxacin	Xtoro	8/25/2014	2014	Alcon	https://www.fda.gov/media/89537/download	Acute otitis externa (AOE)	Acute otitis externa
20	Olopatadine		12/16/2014	2014	Alcon	https://www.fda.gov/media/90610/download	Allergic conjunctivitis	Conjunctivitis	A second period of Pediatric Exclusivity was granted for this moiety.
21	Ketorolac		9/6/2001	2001	Allergan		Itching associated with allergic conjunctivitis	Conjunctivitis
22	Brimonidine		10/10/2001	2001	Allergan		Lower intraocular pressure	Intraocular pressure
23	Ofloxacin		3/12/2003	2003	Allergan		Bacterial conjunctivitis	Conjunctivitis
24	Gatifloxacin		5/19/2009	2009	Allergan	https://www.fda.gov/media/76478/download	Bacterial conjunctivitis in peds 0 - 1 month of age	Conjunctivitis
25	Oxybutynin		2/8/2002	2002	Alza		Detrusor hyperreflexia	Hyperreflexia
26	Fentanyl		1/29/2003	2003	Alza		Chronic pain	Chronic pain
27	Ivabradine		3/30/2019	2019	Amgen		Cardiomyopathy	cardiomyopathy
28	Tavaborole		7/18/2018	2018	Anacor	https://www.fda.gov/media/115355/download	Onychomycosis of the toenail	Onychomycosis
29	Azelastine		8/11/1999	1999	Asta		Itching associated with allergic conjunctivitis	Conjunctivitis
30	Solifenacin		7/20/2017	2017	Astellas	https://www.fda.gov/media/107053/download	Neurogenic detrusor overactivity (NDO)	Neurogenic detrusor overactivity
31	Omeprazole		5/1/2001	2001	AstraZeneca		Gastro-esophageal reflux	Gastro-esophageal reflux
32	Felodipine		8/30/2001	2001	AstraZeneca		Hypertension	Hypertension
33	Lisinopril		11/19/2001	2001	AstraZeneca		Hypertension	Hypertension
34	Tamoxifen		5/16/2002	2002	AstraZeneca		McCune-Albright Syndrome	McCune-Albright Syndrome
35	Budesonide		11/12/2002	2002	AstraZeneca		Asthma & allergic rhinitis	Asthma & Rhinitis
36	Zolmitriptan		12/18/2003	2003	AstraZeneca		Migraine	Migraine
37	Metoprolol		7/27/2006	2006	AstraZeneca		Hypertension	Hypertension
38	Anastrozole		11/14/2007	2007	AstraZeneca	https://www.fda.gov/media/71590/download	Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty.	McCune-Albright Syndrome
39	Bicalutamide		9/19/2008	2008	AstraZeneca	https://www.fda.gov/media/71858/download	Gonadotropin-independent precocious puberty in boys with testotoxicosis	Gonadotropin-independent precocious puberty
40	Quetiapine		1/23/2009	2009	AstraZeneca	https://www.fda.gov/media/75247/download	Schizophrenia and bipolar mania	Schizophrenia and bipolar disorder
41	Esomeprazole	Nexium	5/1/2009	2009	AstraZeneca	https://www.fda.gov/media/76415/download	Treatment of gastroesophageal reflux disease (GERD)	GERD	A second period of Pediatric Exclusivity was granted for this moiety.
42	Rosuvastatin		7/7/2009	2009	AstraZeneca	https://www.fda.gov/media/76967/download	Adjunct to diet to reduce cholesterol and ApoB levels	Reduce cholesterol and ApoB
43	Candesartan		7/20/2009	2009	AstraZeneca	https://www.fda.gov/media/77153/download	Reduce blood pressure	High blood pressure
44	Fulvestrant		2/1/2011	2011	AstraZeneca	https://www.fda.gov/media/79840/download	Progressive precocious puberty in girls with McCune-Albright Syndrome	McCune-Albright Syndrome
45	Budesonide/ Formoterol		1/25/2017	2017	AstraZeneca	https://www.fda.gov/media/102765/download	Asthma	Asthma
46	Insulin Glargine		7/12/1999	1999	Aventis		Diabetes Mellitus	Diabetes
47	Fexofenadine		1/27/2003	2003	Aventis		Allergic rhinitis/urticaria	Rhinitis & urticaria
48	Leflunomide		11/10/2003	2003	Aventis		JRA	JRA
49	Glimepiride		6/9/2005	2005	Aventis		Type II Diabetes	Diabetes
50	Loteprednol/Tobramycin		12/28/2010	2010	Bausch & Lomb	https://www.fda.gov/media/79729/download	Superficial bacterial ocular infection	Ocular infection
51	Esmolol		8/22/2003	2003	Baxter		Hypertension	Hypertension
52	Desflurane		9/13/2006	2006	Baxter		Anesthesia	Anesthesia
53	Ciprofloxacin	CIPRO	12/18/2003	2003	Bayer		Complicated UTI, Acute pyelonephritis	Acute pyelonephritis
54	Fludarabine		4/3/2003	2003	Berlex		Refractory/relapse acute leukemia	Leukemia
55	Sotalol		1/6/2000	2000	Berlex Lab		Arrhythmias	Arrhythmias
56	Sapropterin		3/13/2014	2014	BioMarin	https://www.fda.gov/media/88338/download	Reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to BH4-responsive phenylketonuria (PKU)	Reduce blood phenylalanine
57	Glyburide/Metformin		10/8/2003	2003	BMS		Diabetes Mellitus	Diabetes	This is the first period of Pediatric Exclusivity for glyburide and a second period for metformin.
58	Carboplatin		4/30/2004	2004	BMS		Refractory tumors	Tumors
59	Technetium Tc99 sestamibi		1/11/2008	2008	BMS	https://www.fda.gov/media/71625/download	Kawasaki’s disease	Kawasaki’s disease
60	Ixabepilone		4/5/2011	2011	BMS	https://www.fda.gov/media/80244/download	Solid Tumors	Tumors
61	Efavirenz		1/29/2013	2013	BMS	https://www.fda.gov/media/85111/download	HIV-1 Infection	HIV
62	Entecavir		12/5/2013	2013	BMS	https://www.fda.gov/media/87484/download	Chronic Hepatitis B Virus Infection	Hepatitis B
63	Abatacept		2/14/2017	2017	BMS	https://www.fda.gov/media/103220/download	Polyarticular juvenile idiopathic arthritis (pJIA)	Arthritis
64	Ipilimumab	Yervoy	7/20/2017	2017	BMS	https://www.fda.gov/media/106997/download	Unresectable or metastatic melanoma	Melanoma
65	Dasatinib	Sprycel	9/27/2018	2018	BMS		Philadelphia chromosome positive (Ph+) leukemias, including acute lymphoblastic leukemia (ALL) & chronic myeloid leukemia (CML)	Leukemia
66	Nevirapine	Nevirapine	12/17/2001	2001	Boehringer Ingelheim		Perinatal transmission of HIV infection	HIV
67	Meloxicam		4/15/2005	2005	Boehringer Ingelheim		JRA	JRA
68	Tipranavir		3/7/2008	2008	Boehringer Ingelheim	https://www.fda.gov/media/71369/download	HIV-1 Infection	HIV
69	Tamsulosin		9/17/2009	2009	Boehringer Ingelheim	https://www.fda.gov/media/78045/download	Elevated detrusor leak point pressure associated w/ a known neurological disorder (e.g., spina bifida)	Neurological disorder
70	Tiotropium		12/14/2016	2016	Boehringer Ingelheim	https://www.fda.gov/media/102215/download	Asthma	Asthma
71	Metformin		3/15/2000	2000	Bristol-Myers		Diabetes Mellitus	Diabetes
72	Buspirone		5/22/2000	2000	Bristol-Myers		Generalized anxiety disorder	Anxiety disorder
73	Didanosine		8/13/2001	2001	Bristol-Myers		HIV-1 Infection	HIV
74	Stavudine	Zerit	8/13/2001	2001	Bristol-Myers		HIV-1 Infection	HIV
75	Nefazodone		6/27/2002	2002	Bristol-Myers		Depression	Depression
76	Pravastatin	Pravachol	7/10/2002	2002	Bristol-Myers		Hypercholesterolemia	Hypercholesterolemia
77	Fosinopril		1/27/2003	2003	Bristol-Myers Squibb		Hypertension	Hypertension
78	Atazanavir		6/23/2015	2015	Bristol-Myers Squibb	https://www.fda.gov/media/92643/download	HIV-1 Infection	HIV
79	Modafinil		3/21/2006	2006	Cephalon		Narcolepsy	Narcolepsy
80	Bendamustine		5/24/2012	2012	Cephalon	https://www.fda.gov/media/83605/download	Relapsed or refractory acute leukemia	Leukemia
81	Sunitinib		2/7/2019	2019	CP Pharmaceutical s		Refractory solid & CNS tumors	Tumors
82	Colesevelam		2/17/2009	2009	Daiichi Sankyo	https://www.fda.gov/media/75343/download	Heterozygous familial hypercholesterolemia (heFH)	Hypercholesterolemia
83	Olmesartan		10/7/2009	2009	Daiichi Sankyo	https://www.fda.gov/media/78067/download	Hypertension in pediatric patients 1– 16 years of age	Hypertension
84	Rabeprazole		12/4/2012	2012	Eisai	https://www.fda.gov/media/85217/download	Healing & maintenance of healing of GERD & improvement of GERD symptoms	GERD
85	Rufinamide		1/13/2015	2015	Eisai	https://www.fda.gov/media/90133/download	Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)	Seizures
86	Pemetrexed		12/3/2010	2010	Eli Lilly	https://www.fda.gov/media/80043/download	Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma	Tumors
87	Duloxetine		7/2/2012	2012	Eli Lilly	https://www.fda.gov/media/83825/download	Major depressive disorder (MDD)	Depression
88	Prasugrel		5/23/2016	2016	Eli Lilly	https://www.fda.gov/media/98405/download	Vaso-occlusive crises (VOC) in pediatric patients with sickle cell disease (SCD)	Vaso-occlusive crises
89	Tadalafil	Cialis	11/16/2017	2017	Eli Lilly	https://www.fda.gov/media/109413/download	Duchenne muscular dystrophy (DMD)	Duchenne muscular dystrophy
90	Betaxolol		2/28/2007	2007	Falcon		Elevated intraocular pressure	Intraocular pressure	A second period of Pediatric Exclusivity was granted for this moiety (effective 6/07 when it received Hatch-Waxman exclusivity)
91	Citalopram		7/12/2002	2002	Forest		Depression	Depression
92	Memantine		6/16/2014	2014	Forest Labs	https://www.fda.gov/media/88437/download	Autism & Autism Spectrum Disorder (ASD)	Autism
93	Asenapine		3/3/2015	2015	Forest Labs	https://www.fda.gov/media/91103/download	Schizophrenia & bipolar disorder	Schizophrenia and bipolar disorder
94	Tocilizumab		7/18/2018	2018	Genentech/ Hoffmann-La Roche	https://www.fda.gov/media/115367/download	Systemic Juvenile Idiopathic Arthritis (SJIA) and Polyarticular Course Juvenile Idiopathic Arthritis (PcJIA)	Arthritis
95	Emtricitabine		5/24/2006	2006	Gilead		HIV-1 Infection	HIV
96	Tenofovir		9/6/2011	2011	Gilead		HIV-1 Infection	HIV
97	Tenofovir		11/15/2018	2018	Gilead	https://www.fda.gov/media/118889/download	HBV Infection	Hepatitis B	A second period of Pediatric Exclusivity was granted for this moiety.
98	Abacavir		12/14/1998	1998	Glaxo		HIV Infection	HIV
99	Ranitidine		1/19/1999	1999	Glaxo		Gastro-esophageal reflux	Gastro-esophageal reflux
100	Lamivudine		9/22/2000	2000	Glaxo		HIV-1 Infection	HIV