AMIKIN Drug Patent Profile
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Which patents cover Amikin, and when can generic versions of Amikin launch?
Amikin is a drug marketed by Apothecon and is included in four NDAs.
The generic ingredient in AMIKIN is amikacin sulfate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amikin
A generic version of AMIKIN was approved as amikacin sulfate by MEITHEAL on September 28th, 1993.
Summary for AMIKIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 2 |
Patent Applications: | 3,099 |
Formulation / Manufacturing: | see details |
DailyMed Link: | AMIKIN at DailyMed |
Recent Clinical Trials for AMIKIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Raja Isteri Pengiran Anak Saleha Hospital | N/A |
Thammasat University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for AMIKIN
US Patents and Regulatory Information for AMIKIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apothecon | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | amikacin sulfate | INJECTABLE;INJECTION | 050618-002 | Nov 30, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apothecon | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | amikacin sulfate | INJECTABLE;INJECTION | 050618-001 | Nov 30, 1987 | DISCN | No | No | ⤷ 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 |