DEXRAZOXANE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for dexrazoxane hydrochloride and what is the scope of patent protection?
Dexrazoxane hydrochloride
is the generic ingredient in three branded drugs marketed by Eugia Pharma, Gland, Hikma, Clinigen, and Pfizer, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.Six suppliers are listed for this compound.
Summary for DEXRAZOXANE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 58 |
| Patent Applications: | 715 |
| What excipients (inactive ingredients) are in DEXRAZOXANE HYDROCHLORIDE? | DEXRAZOXANE HYDROCHLORIDE excipients list |
| DailyMed Link: | DEXRAZOXANE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DEXRAZOXANE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 2/Phase 3 |
| Maria Sklodowska-Curie National Research Institute of Oncology | Phase 3 |
| Polish Medical Research Agency | Phase 3 |
Pharmacology for DEXRAZOXANE HYDROCHLORIDE
| Drug Class | Cytoprotective Agent |
Medical Subject Heading (MeSH) Categories for DEXRAZOXANE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DEXRAZOXANE HYDROCHLORIDE
US Patents and Regulatory Information for DEXRAZOXANE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland | DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 207321-001 | Nov 28, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-002 | May 26, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 076068-002 | Sep 28, 2004 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 200752-002 | Oct 19, 2011 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland | DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 207321-002 | Dec 16, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | DEXRAZOXANE HYDROCHLORIDE | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 200752-001 | Oct 19, 2011 | AP | RX | No | Yes | ⤷ 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 DEXRAZOXANE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Clinigen | TOTECT | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 022025-001 | Sep 6, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-001 | May 26, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-002 | May 26, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-002 | May 26, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-002 | May 26, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZINECARD | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 020212-001 | May 26, 1995 | ⤷ 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.
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