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Last Updated: July 2, 2020

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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 Aci Healthcare Ltd, Aurobindo Pharma, Ranbaxy Labs Ltd, Pfizer, Accord Hlthcare, Anda Repository, Austarpharma Llc, Cadila, Chartwell Molecular, Fosun Pharma, Heritage Pharma, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan, Mylan Pharms Inc, Oxford Pharms, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Wockhardt, 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.

Sertraline hydrochloride has fifty-two patent family members in forty-five countries.

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

Summary for sertraline hydrochloride
Recent Clinical Trials for sertraline hydrochloride

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SponsorPhase
University of Sao PauloPhase 2
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 2
University of North Carolina, Chapel HillPhase 4

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Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 50MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 25MG BASETABLET;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
Medical Subject Heading (MeSH) Categories for sertraline hydrochloride
Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZOLOFT TABLET;ORAL sertraline hydrochloride 019839 2005-11-09
ZOLOFT CONCENTRATE;ORAL sertraline hydrochloride 020990 2003-12-09

US Patents and Regulatory Information for sertraline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 076540-003 Mar 20, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride CONCENTRATE;ORAL 020990-001 Dec 7, 1999 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET;ORAL 075719-003 Jun 30, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-002 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-002 Dec 30, 1991   Start Trial   Start Trial
Pfizer ZOLOFT sertraline hydrochloride TABLET;ORAL 019839-005 Mar 6, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Express Scripts
Mallinckrodt
Moodys
Johnson and Johnson

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