Deep knowledge on 
 small-molecule drugs and 
 the 110,000 global patents 
 covering them 

Free Patent Expiration Alerts


Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Sertraline hydrochloride - Generic Drug Details

« Back to Dashboard
Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Wockhardt, Aurobindo Pharma, Zydus Pharms Usa, Sun Pharm Inds (in), Sandoz, Sun Pharm Inds, Ivax Sub Teva Pharms, Accord Hlthcare, Mylan Pharms Inc, Roxane, Pfizer, Dr Reddys Labs Ltd, Actavis Elizabeth, Ranbaxy Labs Ltd, Cipla Ltd, Watson Labs, Hikma Pharms, Teva, Torrent Pharms, Lupin, Mylan, Prosam Labs, Austarpharma Llc, Sun Pharm Inds Ltd, Apotex Inc, Invagen Pharms, and Pliva Hrvatska Doo, and is included in thirty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-eight patent family members in forty-five countries.

There are twenty-two drug master file entries for sertraline hydrochloride. Fifty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sertraline hydrochloride

Tradenames:2
Patents:2
Applicants:27
NDAs:31
Drug Master File Entries: see list22
Suppliers / Packaging: see list57
Therapeutic Class:Antidepressants
Anxiolytics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG
<disabled><disabled>TABLET; ORAL200MG

Clinical Trials for: sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077670-001Feb 6, 2007RXNo<disabled><disabled>
Sun Pharm Inds (in)
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL078108-001Feb 6, 2007RXNo<disabled><disabled>
Sun Pharm Inds Ltd
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride
TABLET;ORAL077977-004Feb 6, 2007RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: sertraline hydrochloride

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-004Dec 30, 19914,962,128*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-004Dec 30, 19915,248,699*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,248,699*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: sertraline hydrochloride

Country Document Number Estimated Expiration
Ukraine72743<disabled in preview>
Denmark1121107<disabled in preview>
Iceland5906<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Connect with Social Media:

`abc