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 26th, 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 |
Recent Clinical Trials for GEODON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Pharma Global Development, Inc. | Phase 2 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 1 |
| Duke University | Phase 1 |
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
| 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 | |||
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-003 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825-001 | 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 mesylate | POWDER;INTRAMUSCULAR | 020919-001 | Jun 21, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer Inc | GEODON | ziprasidone hydrochloride | SUSPENSION;ORAL | 021483-001 | Mar 29, 2006 | ⤷ 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 200101131 | ⤷ Sign Up | |
| Japan | H05504783 | ⤷ Sign Up | |
| Austria | 217325 | ⤷ Sign Up | |
| Norway | 320296 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GEODON
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
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