PROZAC Drug Patent Profile

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Which patents cover Prozac, and when can generic versions of Prozac launch?

Prozac is a drug marketed by Eli Lilly And Co and Lilly and is included in four NDAs.

The generic ingredient in PROZAC is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prozac

A generic version of PROZAC was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2^nd, 2001.

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Summary for PROZAC

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	110
Patent Applications:	3,819
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROZAC
Drug Sales Revenues:	Drug sales revenues for PROZAC
What excipients (inactive ingredients) are in PROZAC?	PROZAC excipients list
DailyMed Link:	PROZAC at DailyMed

Drug patent expirations by year for PROZAC

Recent Clinical Trials for PROZAC

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

Sponsor	Phase
Avy L. & Roberta L. Miller Foundation	Phase 2
Stanford University	Phase 2
Milton S. Hershey Medical Center	Early Phase 1

See all PROZAC clinical trials

Pharmacology for PROZAC

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PROZAC

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

US Patents and Regulatory Information for PROZAC

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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
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	AB1	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-004	Jun 15, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 PROZAC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PROZAC

See the table below for patents covering PROZAC around the world.

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I226829		⤷ Try a Trial
Japan	H0745405		⤷ Try a Trial
Hong Kong	1040055		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for PROZAC

Recent Clinical Trials for PROZAC

Pharmacology for PROZAC

Anatomical Therapeutic Chemical (ATC) Classes for PROZAC

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