FDA Approved Products
6,646 products with lifecycle intelligence, competitive pressure scores, and patent timelines.
AEMCOLO
rifamycin sodium
Post-LOE
Cosmo Pharmaceuticals
ORAL · TABLET, DELAYED RELEASE
2018
NDA35/100
BRIVIACT
brivaracetam
Post-LOE
UCB Pharma
ORAL · SOLUTION
partial-onset seizures in patients 1 month of ageolder
2016
NDA35/100
BRIVIACT
brivaracetam
Post-LOE
UCB Pharma
INTRAVENOUS · SOLUTION
partial-onset seizures in patients 1 month of ageolder
2016
NDA35/100
COREG CR
carvedilol phosphate
Post-LOE
Viatris (2)
ORAL · CAPSULE, EXTENDED RELEASE
mild-to-severe chronic heart failure of ischemiccardiomyopathic origin+10
2006
NDA35/100
FEXINIDAZOLE
fexinidazole
LOE Approaching
Sanofi
ORAL · TABLET
2021
SMNDA35/100
IWILFIN
eflornithine hydrochloride
LOE Approaching
ORAL · TABLET
relapse in adultmultimodality therapy including anti-GD2 immunotherapy
2023
NDA35/100
LEGUBETI
acetylcysteine lysine
LOE Approaching
R-Pharm US
ORAL · FOR SOLUTION
2024
NDA35/100
LEXAPRO
escitalopram oxalate
LOE Approaching
AbbVie
ORAL · SOLUTION
2002
NDA35/100
LEXAPRO
escitalopram
LOE Approaching
AbbVie
ORAL · TABLET
anxiety
2002
NDA35/100
NAPROXEN SODIUM
naproxen sodium
Post-LOE
ORAL · CAPSULE
2006
NDA35/100
NUCYNTA
tapentadol hydrochloride
LOE Approaching
ORAL · SOLUTION
2012
NDA35/100
NUCYNTA
tapentadol hydrochloride
LOE Approaching
ORAL · TABLET
acute pain severe enough to require an opioid analgesicfor which alternative treatments are inadequate in adults+1
2008
NDA35/100
PRADAXA
dabigatran etexilate
Post-LOE
Boehringer Ingelheim
ORAL · PELLETS
venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of agerecurrence of VTE in pediatric patients aged 3 months to less than 12 years of age
2021
NDA35/100
PRETOMANID
pretomanid
Post-LOE
Viatris (2)
ORAL · TABLET
2019
NDA35/100
PRIMATENE MIST
epinephrine inhalation
Post-LOE
INHALATION · AEROSOL, METERED
2018
NDA35/100
PROMACTA KIT
eltrombopag olamine
Post-LOE
Novartis
ORAL · FOR SUSPENSION
thrombocytopenia in adultolder with persistent+8
2015
NDA35/100
REXTOVY
naloxone hydrochloride
Post-LOE
R-Pharm US
NASAL · SPRAY, METERED
2023
NDA35/100
ROZLYTREK
entrectinib
LOE Approaching
Roche
ORAL · PELLETS
detected by an FDA-approved testdetected by an FDA-approved test without a known acquired resistance mutation+2
2023
SMNDA35/100
SKELAXIN
metaxalone
Post-LOE
Pfizer
ORAL · TABLET
1962
NDA35/100
TECHNEGAS KIT
kit for the preparation of technetium tc 99m-labeled carbon inhalation aerosol
LOE Approaching
Cyclomedica
INHALATION · AEROSOL
2023
NDA35/100
8-HOUR BAYER
aspirin
LOE Approaching
Bayer
ORAL · TABLET, EXTENDED RELEASE
1965
NDA30/100
8-MOP
methoxsalen
LOE Approaching
Bausch + Lomb
ORAL · CAPSULE
psoriasis
1954
NDA30/100
ABACAVIR SULFATE AND LAMIVUDINE
abacavir sulfate; lamivudine
Growth
ORAL · TABLET, FOR SUSPENSION
HIV-1 infection
2023
NDA30/100
ABELCET
amphotericin b
LOE Approaching
Leadiant Biosciences
INJECTION · INJECTABLE, LIPID COMPLEX
Cryptococcal Meningitis in HIV-infected patients (see )unacceptable toxicity precludes the use of amphotericin B deoxycholate+1
1995
NDA30/100