Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Last Updated: December 8, 2019

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Iron sucrose - Generic Drug Details

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What are the generic drug sources for iron sucrose and what is the scope of patent protection?

Iron sucrose is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are eighty-two drug master file entries for iron sucrose. Two suppliers are listed for this compound.

Summary for iron sucrose
Recent Clinical Trials for iron sucrose

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

SponsorPhase
University Medical Centre LjubljanaPhase 3
University of Colorado, DenverPhase 4
ASST Fatebenefratelli SaccoPhase 1

See all iron sucrose clinical trials

Pharmacology for iron sucrose

US Patents and Regulatory Information for iron sucrose

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-005 Mar 29, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-003 Mar 29, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-002 Mar 20, 2005 RX Yes No   Start Trial   Start Trial   Start Trial
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-004 Feb 9, 2007 RX Yes No   Start Trial   Start Trial   Start Trial
Am Regent VENOFER iron sucrose INJECTABLE;INTRAVENOUS 021135-001 Nov 6, 2000 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
McKinsey
Baxter
Dow
Moodys

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