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Profile for Tradename: PAXIL CR

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Paxil Cr is a drug marketed by Apotex Technologies and is included in one NDA. It is available from five suppliers. There are six patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in PAXIL CR is paroxetine hydrochloride. There are twenty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

Summary for Tradename: PAXIL CR

Patents:6
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: PAXIL CR

Clinical Trials for: PAXIL CR

PAXIL CR Bioequivalence Study
Status: Completed Condition: Two Single Doses of Controlled Release Paroxetine Given 14 Days Apart; Depressive Disorder; Healthy Volunteer

Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome
Status: Completed Condition: Fibromyalgia Syndrome

Paxil CR Bioequivalence Study Brazil - Fed Administration
Status: Completed Condition: Depressive Disorder; Healthy Volunteers

Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
Status: Terminated Condition: Depressive Disorder

Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Status: Completed Condition: Postmenopausal Symptoms

Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)
Status: Completed Condition: Posttraumatic Stress Disorder (PTSD)

Interaction Between Paroxetine and Telaprevir
Status: Terminated Condition: Hepatitis C Infection; Depression

24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Status: Completed Condition: Hot Flashes

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Status: Completed Condition: Postmenopausal Symptoms

Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Status: Completed Condition: Hot Flashes

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999RXNo7,229,640*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-003Dec 6, 2000RXYes5,872,132*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999RXNo7,229,640*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-001Feb 16, 1999RXNo6,121,291*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936-002Feb 16, 1999RXNo5,872,132*PED<disabled>Y<disabled>
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Paragraph IV activity for: PAXIL CR

Drugname Dosage Strength RLD Submissiondate
paroxetine hydrochlorideExtended-release Tablets37.5 mgPaxil CR5/19/2009
paroxetine hydrochlorideExtended-release Tablets25 mgPaxil CR9/9/2005

Non-Orange Book Patents for Tradename: PAXIL CR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,856,493 Process for making novel form of paroxeting hydrochloride anhydrate<disabled in preview>
6,080,759 Paroxetine hydrochloride form A<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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