GEODON Drug Patent Profile

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When do Geodon patents expire, and when can generic versions of Geodon launch?

Geodon is a drug marketed by Viatris and Pfizer Inc and is included in three NDAs.

The generic ingredient in GEODON is ziprasidone mesylate. There are twenty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Geodon

A generic version of GEODON was approved as ziprasidone mesylate by GLAND PHARMA LTD on December 26^th, 2019.

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Summary for GEODON

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	48
Drug Prices:	Drug price information for GEODON
What excipients (inactive ingredients) are in GEODON?	GEODON excipients list
DailyMed Link:	GEODON at DailyMed

Drug patent expirations by year for GEODON

Recent Clinical Trials for GEODON

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

Sponsor	Phase
Astellas Pharma Global Development, Inc.	Phase 2
Duke University	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all GEODON clinical trials

Pharmacology for GEODON

Drug Class	Atypical Antipsychotic

Paragraph IV (Patent) Challenges for GEODON

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 GEODON

GEODON is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting GEODON

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷ Sign Up

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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
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-001	Feb 5, 2001	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001	AB	RX	Yes	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 GEODON

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for GEODON

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

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Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	796	Inclusion complexes of aryl-heterocyclic salts.	⤷ Sign Up
South Korea	20000006143		⤷ Sign Up
Australia	9717098		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for GEODON

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904273	PA2003004,C0904273	Lithuania	⤷ Sign Up	PRODUCT NAME: ZIPRASIDONUM (5-(2-(4-(1,2-BENZIZOTIAZOL-3-IL)-1-PIPERAZINIL)ETIL)-6-CHLOR-1,3-DIHIDRO-2H-INDOL-2-ONAS); REGISTRATION NO/DATE: 02/7887/8 20021002
0904273	PA2003004	Lithuania	⤷ Sign Up	PRODUCT NAME: ZIPRASIDONUM (5-(2-(4-(1,2-BENZIZOTIAZOL-3-IL)-1-PIPERAZINIL)ETIL)-6-CHLOR-1,3-DIHIDRO-2H-INDOL-2-ONAS); REGISTRATION NO/DATE: 02/7887/8 20021002
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description