Sertraline hydrochloride - Generic Drug Details

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What are the generic drug sources for sertraline hydrochloride and what is the scope of freedom to operate?

Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Almatica, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Viatris, Accord Hlthcare, Anda Repository, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Norvium Bioscience, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for sertraline hydrochloride. Forty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for sertraline hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	26
NDAs:	33
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	329
Patent Applications:	7,079
What excipients (inactive ingredients) are in sertraline hydrochloride?	sertraline hydrochloride excipients list
DailyMed Link:	sertraline hydrochloride at DailyMed

Recent Clinical Trials for sertraline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alberta Health services	Phase 2
St. Justine's Hospital	Phase 2
McMaster University	Phase 2

See all sertraline hydrochloride clinical trials

Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 100MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 50MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 25MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sertraline hydrochloride

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for sertraline hydrochloride

Antidepressive Agents
Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sertraline hydrochloride

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOLOFT	Tablets	sertraline hydrochloride	150 mg and 200 mg	019839	1	2005-11-09
ZOLOFT	Oral Concentrate	sertraline hydrochloride	20 mg/mL	020990	1	2003-12-09

US Patents and Regulatory Information for sertraline hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anda Repository	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077818-001	Feb 6, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077977-001	Feb 6, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Invagen Pharms	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077397-001	Feb 6, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sertraline hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	⤷ Sign Up	⤷ Sign Up
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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