ISOSULFAN BLUE - Generic Drug Details
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What are the generic sources for isosulfan blue and what is the scope of freedom to operate?
Isosulfan blue
is the generic ingredient in two branded drugs marketed by Am Regent, Beloteca, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, Somerset Theraps Llc, and Covidien, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for isosulfan blue. Five suppliers are listed for this compound.
Summary for ISOSULFAN BLUE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 15 |
Patent Applications: | 681 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ISOSULFAN BLUE |
What excipients (inactive ingredients) are in ISOSULFAN BLUE? | ISOSULFAN BLUE excipients list |
DailyMed Link: | ISOSULFAN BLUE at DailyMed |
Recent Clinical Trials for ISOSULFAN BLUE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
OnLume Inc. | N/A |
National Institutes of Health (NIH) | N/A |
University of Wisconsin, Madison | N/A |
US Patents and Regulatory Information for ISOSULFAN BLUE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Institutional | ISOSULFAN BLUE | isosulfan blue | INJECTABLE;INJECTION | 090874-001 | Jul 20, 2010 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Beloteca | ISOSULFAN BLUE | isosulfan blue | INJECTABLE;INJECTION | 210714-001 | Jan 16, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fresenius Kabi Usa | ISOSULFAN BLUE | isosulfan blue | INJECTABLE;INJECTION | 211869-001 | Sep 8, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Covidien | LYMPHAZURIN | isosulfan blue | INJECTABLE;INJECTION | 018310-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |