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Generated: September 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203565

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NDA 203565 describes INJECTAFER, which is a drug marketed by Luitpold Pharms Inc 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 fourteen 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 NDA: 203565

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength750MG IRON/15ML (50MG IRON/ML)
Approval Date:Jul 25, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 25, 2016
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Feb 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent 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


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
McKesson
Express Scripts
Teva
McKinsey
Colorcon
Boehringer Ingelheim
UBS
Queensland Health
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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