AMPHOTERICIN B - Generic Drug Details
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What are the generic drug sources for amphotericin b and what is the scope of patent protection?
Amphotericin b
is the generic ingredient in five branded drugs marketed by Apothecon, Leadiant Biosci Inc, Alkopharma Usa, Astellas, Eugia Pharma, Spil, Abbott, Abraxis Pharm, Teva Parenteral, Xgen Pharms, and Bristol Myers Squibb, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirteen drug master file entries for amphotericin b. Five suppliers are listed for this compound.
Summary for AMPHOTERICIN B
| US Patents: | 0 |
| Tradenames: | 5 |
| Applicants: | 11 |
| NDAs: | 14 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 170 |
| Patent Applications: | 6,746 |
| Drug Prices: | Drug price trends for AMPHOTERICIN B |
| What excipients (inactive ingredients) are in AMPHOTERICIN B? | AMPHOTERICIN B excipients list |
| DailyMed Link: | AMPHOTERICIN B at DailyMed |
Recent Clinical Trials for AMPHOTERICIN B
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of Health Science of Porto Alegre | Phase 3 |
| Huashan Hospital | Phase 4 |
| Helwan University | N/A |
Pharmacology for AMPHOTERICIN B
| Drug Class | Lipid-based Polyene Antifungal Polyene Antifungal |
Medical Subject Heading (MeSH) Categories for AMPHOTERICIN B
Anatomical Therapeutic Chemical (ATC) Classes for AMPHOTERICIN B
US Patents and Regulatory Information for AMPHOTERICIN B
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Xgen Pharms | AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 063206-001 | Apr 29, 1992 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alkopharma Usa | AMPHOTEC | amphotericin b | INJECTABLE, LIPID COMPLEX;INJECTION | 050729-002 | Nov 22, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apothecon | FUNGIZONE | amphotericin b | LOTION;TOPICAL | 060570-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abraxis Pharm | AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 062728-001 | Apr 13, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | FUNGIZONE | amphotericin b | SUSPENSION;ORAL | 050341-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eugia Pharma | AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 214010-001 | Nov 17, 2022 | 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 AMPHOTERICIN B
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | ABELCET | amphotericin b | INJECTABLE, LIPID COMPLEX;INJECTION | 050724-001 | Nov 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Leadiant Biosci Inc | ABELCET | amphotericin b | INJECTABLE, LIPID COMPLEX;INJECTION | 050724-001 | Nov 20, 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.
ISSN: 2162-2639
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