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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 ten 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. Fifty-eight 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 list10

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<disabled><disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
CONCENTRATE;ORAL020990-001Dec 7, 1999RXYes6,727,283*PED<disabled>Y<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-003Dec 30, 1991DISCNNo<disabled><disabled>
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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, 19965,744,501<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19915,248,699*PED<disabled>
Pfizer
ZOLOFT
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 19914,962,128*PED<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
Estonia200100221<disabled in preview>
Iceland5906<disabled in preview>
Hong Kong1040199<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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