Is there a generic for Ferric derisomaltose?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ferric derisomaltose. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Ferric derisomaltose?

MONOFERRIC (NDA 208171, PHARMACOSMOS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ferric derisomaltose?

The Orange Book lists 5 patents against Ferric derisomaltose products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ferric derisomaltose are approved?

Ferric derisomaltose is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Ferric derisomaltose

Ferric derisomaltose: 1 brand, 0 generics; first approved Jan 16, 2020; on patent until Mar 25, 2029.

On patentHas discontinued products

Generic status & protection

Protected until Mar 25, 2029 (earliest listed patent expiry).

Earliest patent expiry Mar 25, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 25, 2029

in 2 yr 9 mo

Originator applications

Brand (NDA) products

MONOFERRICRLDRS

PHARMACOSMOSNDA 20817120203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/ML (100MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
500MG/5ML (100MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
1GM/10ML (100MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12030962	Mar 25, 2029	in 2 yr 9 mo	SubstanceProduct
10414831	Mar 25, 2029	in 2 yr 9 mo	SubstanceProduct
11851504	Mar 25, 2029	in 2 yr 9 mo	SubstanceProduct
8815301	Aug 14, 2029	in 3 yr 1 mo	SubstanceProductU-2734
11633489	Jun 22, 2036	in 10 yr 1 mo	U-3594

FDA approval span

Approval history

First approval

Jan 16, 2020

6 yr 7 mo ago

Most recent approval

Jan 16, 2020

6 yr 7 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%

Generic (ANDA) 00%

Ferric derisomaltose — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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