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Generated: November 15, 2018

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Details for New Drug Application (NDA): 203565

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NDA 203565 describes INJECTAFER, which is a drug marketed by Luitpold and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the INJECTAFER profile page.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
Summary for 203565
Tradename:INJECTAFER
Applicant:Luitpold
Ingredient:ferric carboxymaltose
Patents:4
Generic Entry Opportunity Date for 203565
Generic Entry Date for 203565*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 203565
Ingredient-typeIron
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 203565
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565 NDA American Regent, Inc. 0517-0650 0517-0650-01 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) > 15 mL in 1 VIAL, SINGLE-DOSE
INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565 NDA American Regent, Inc. 0517-0650 0517-0650-02 2 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-02) > 15 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength750MG IRON/15ML (50MG IRON/ML)
Approval Date:Jul 25, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Feb 13, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
Patent:➤ Try a Free TrialPatent Expiration:Jan 8, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.

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Daiichi Sankyo
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Farmers Insurance
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Moodys
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Harvard Business School

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