Amphotericin b - Generic Drug Details
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What are the generic drug sources for amphotericin b and what is the scope of freedom to operate?
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | FUNGIZONE | amphotericin b | OINTMENT;TOPICAL | 050313-001 | 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 | ||||
Xgen Pharms | AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 063206-001 | Apr 29, 1992 | RX | No | Yes | ⤷ 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 | ||||
Abbott | AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 064141-001 | Dec 23, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Leadiant Biosci Inc | ABELCET | amphotericin b | INJECTABLE, LIPID COMPLEX;INJECTION | 050724-001 | Nov 20, 1995 | RX | Yes | 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 amphotericin b
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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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