AMBISOME Drug Patent Profile
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Which patents cover Ambisome, and when can generic versions of Ambisome launch?
Ambisome is a drug marketed by Astellas and is included in one NDA.
The generic ingredient in AMBISOME is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ambisome
A generic version of AMBISOME was approved as amphotericin b by XGEN PHARMS on April 29th, 1992.
Summary for AMBISOME
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 58 |
Patent Applications: | 4,470 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AMBISOME |
What excipients (inactive ingredients) are in AMBISOME? | AMBISOME excipients list |
DailyMed Link: | AMBISOME at DailyMed |
Recent Clinical Trials for AMBISOME
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
F2G Biotech GmbH | Phase 3 |
Iqvia Pty Ltd | Phase 3 |
Dongkook Pharmaceutical Co., Ltd. | Phase 1 |
Pharmacology for AMBISOME
Anatomical Therapeutic Chemical (ATC) Classes for AMBISOME
US Patents and Regulatory Information for AMBISOME
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 AMBISOME
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMBISOME
See the table below for patents covering AMBISOME around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 629388 | ⤷ Try a Trial | |
Australia | 598958 | ⤷ Try a Trial | |
Germany | 3864495 | ⤷ Try a Trial | |
Norway | 174833 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |