ZIPRASIDONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for ziprasidone hydrochloride and what is the scope of patent protection?
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 |
Pharmacology for ZIPRASIDONE HYDROCHLORIDE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for ZIPRASIDONE HYDROCHLORIDE
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
| 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 | 204117-003 | Dec 27, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Lifesciences | ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 208988-002 | Aug 22, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 202395-001 | Oct 10, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Macleods Pharms Ltd | ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 204375-004 | Feb 17, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 204375-003 | Feb 17, 2017 | 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
| 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 |
| 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 |
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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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