Ziprasidone hydrochloride - Generic Drug Details

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

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Viatris, Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, Zydus Lifesciences, and Pfizer Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for ziprasidone hydrochloride. Twenty-three suppliers are listed for this compound.

Summary for ziprasidone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	146
Patent Applications:	478
What excipients (inactive ingredients) are in ziprasidone hydrochloride?	ziprasidone hydrochloride excipients list
DailyMed Link:	ziprasidone hydrochloride at DailyMed

Recent Clinical Trials for ziprasidone hydrochloride

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Shanghai Mental Health Center	Phase 4
Shanghai Jiao Tong University School of Medicine	Phase 4

See all ziprasidone hydrochloride clinical trials

Pharmacology for ziprasidone hydrochloride

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ziprasidone hydrochloride

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZIPRASIDONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GEODON	Capsules	ziprasidone hydrochloride	20 mg, 40 mg, 60 mg and 80 mg	020825	5	2005-02-07

US Patents and Regulatory Information for ziprasidone 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
Aurobindo Pharma	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	204117-002	Dec 27, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	204117-001	Dec 27, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077561-002	Mar 2, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077561-004	Mar 2, 2012	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 ziprasidone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	⤷ Sign Up	⤷ Sign Up
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	⤷ Sign Up	⤷ Sign Up
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	⤷ Sign Up	⤷ Sign Up
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-001	Feb 5, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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