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ZOLOFT Drug Profile

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Zoloft is a drug marketed by Pfizer and is included in two NDAs. It is available from thirteen suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Sixty-one suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for Tradename: ZOLOFT

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list13
Drug Prices: :see details

Pharmacology for Tradename: ZOLOFT

Clinical Trials for: ZOLOFT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-005Mar 6, 1996RXNo
Pfizer
ZOLOFT
sertraline hydrochloride
CONCENTRATE;ORAL020990-001Dec 7, 1999RXYes7,067,555*PEDApr 11, 2020Y
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-003Dec 30, 1991DISCNNo
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Expired Patents for Tradename: ZOLOFT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-005Mar 6, 19964,962,128*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-003Dec 30, 19914,536,518*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,744,501<disabled>
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Paragraph IV activity for: ZOLOFT

Drugname Dosage Strength RLD Submissiondate
sertraline hydrochlorideTablets150 mg and 200 mgZoloft11/9/2005

International Patent Family for Tradename: ZOLOFT

Country Document Number Estimated Expiration
China1184962<disabled in preview>
Australia766202<disabled in preview>
Morocco26698<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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