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Last Updated: November 24, 2024

Isosulfan blue - Generic Drug Details


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What are the generic drug sources for isosulfan blue and what is the scope of patent protection?

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
Drug Prices for isosulfan blue

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Recent Clinical Trials for isosulfan blue

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OnLume Inc.N/A
National Institutes of Health (NIH)N/A
University of Wisconsin, MadisonN/A

See all isosulfan blue clinical trials

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
Am Regent ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 210294-001 May 17, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 090874-001 Jul 20, 2010 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Somerset Theraps Llc ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 210558-001 Jul 12, 2019 DISCN 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
Eugia Pharma ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 206831-001 Feb 2, 2016 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
Fresenius Kabi Usa ISOSULFAN BLUE isosulfan blue SOLUTION;SUBCUTANEOUS 211869-001 Sep 8, 2022 DISCN No 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

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