Question 1

Is there a generic for Iron sucrose?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Iron sucrose, referencing the brand VENOFER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Iron sucrose?

Accepted Answer

VENOFER (NDA 021135, AM REGENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Iron sucrose have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Iron sucrose. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Iron sucrose are approved?

Accepted Answer

Iron sucrose is approved in the following dosage form: injectable.

Product	Applicant	Application	TE	Approved
IRON SUCROSE×3	INTL MEDICATION SYS	ANDA 208977	AB	Aug 08, 2025
IRON SUCROSE×3	MYLAN LABS LTD	ANDA 212559	AB	Aug 08, 2025
IRON SUCROSE×3	SANDOZ	ANDA 212340	AB	Aug 08, 2025

Iron sucrose

Brand (NDA) products · injectable

Generic (ANDA) products (3)

Marketing exclusivity (3)

Listed patents

Iron sucrose — frequently asked questions

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