ISOSULFAN BLUE - Generic Drug Details
✉ Email this page to a colleague
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: | 604 |
| 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 |
|---|---|
| University of Wisconsin, Madison | N/A |
| OnLume Inc. | N/A |
| National Institutes of Health (NIH) | 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 | SOLUTION;SUBCUTANEOUS | 090874-001 | Jul 20, 2010 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Am Regent | ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 210294-001 | May 17, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 213130-001 | Nov 3, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 211869-001 | Sep 8, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Covidien | LYMPHAZURIN | isosulfan blue | SOLUTION;SUBCUTANEOUS | 018310-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
