paroxetine hydrochloride hydrate — Competitive Intelligence Brief

paroxetine hydrochloride hydrate (paroxetine hydrochloride hydrate) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Selective serotonin reuptake inhibitor (SSRI). Area: Psychiatry / Neurology.

phase 3 Selective serotonin reuptake inhibitor (SSRI) Serotonin transporter (SERT) Psychiatry / Neurology Small molecule

Target snapshot

paroxetine hydrochloride hydrate (paroxetine hydrochloride hydrate) — GlaxoSmithKline. Paroxetine selectively inhibits the reuptake of serotonin at the neuronal synapse, increasing serotonin availability in the brain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
paroxetine hydrochloride hydrate TARGET	paroxetine hydrochloride hydrate	GlaxoSmithKline	phase 3	Selective serotonin reuptake inhibitor (SSRI)	Serotonin transporter (SERT)
Lexapro	escitalopram	Generic (originally Lundbeck/Forest)	marketed	Selective Serotonin Reuptake Inhibitor (SSRI)	Serotonin (5-HT) reuptake transporter	2002-08-14
Prozac	fluoxetine	Eli Lilly and Company	marketed	Selective Serotonin Reuptake Inhibitor (SSRI)	Serotonin reuptake transporter	1987-12-29
Sertraline HCl	Sertraline HCl	Tri-Service General Hospital	marketed	Selective serotonin reuptake inhibitor (SSRI)	Serotonin transporter (SERT)
Sertraline [Zoloft]	Sertraline [Zoloft]	Johns Hopkins University	marketed	Selective serotonin reuptake inhibitor (SSRI)	Serotonin transporter (SERT)
oral escitalopram	oral escitalopram	NYU Langone Health	marketed	Selective serotonin reuptake inhibitor (SSRI)	Serotonin transporter (SERT)
Placebo & Citalopram	Placebo & Citalopram	University of Colorado, Denver	marketed	Selective serotonin reuptake inhibitor (SSRI)	Serotonin transporter (SERT)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Selective serotonin reuptake inhibitor (SSRI) class)

1. University of Texas Southwestern Medical Center · 3 drugs in this class
2. Johns Hopkins University · 2 drugs in this class
3. GlaxoSmithKline · 2 drugs in this class
4. Daiichi Sankyo Co., Ltd. · 1 drug in this class
5. Guangdong Provincial People's Hospital · 1 drug in this class
6. Janssen Research & Development, LLC · 1 drug in this class
7. Medical University of Vienna · 1 drug in this class
8. Massachusetts General Hospital · 1 drug in this class
9. Fundació Sant Joan de Déu · 1 drug in this class
10. Centre Hospitalier Universitaire Dijon · 1 drug in this class