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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208171


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NDA 208171 describes MONOFERRIC, which is a drug marketed by Pharmacosmos and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the MONOFERRIC profile page.

The generic ingredient in MONOFERRIC is ferric derisomaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric derisomaltose profile page.
Summary for 208171
Tradename:MONOFERRIC
Applicant:Pharmacosmos
Ingredient:ferric derisomaltose
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208171
Generic Entry Date for 208171*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.

Suppliers and Packaging for NDA: 208171
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171 NDA Pharmacosmos Therapeutics Inc. 73594-9301 73594-9301-2 5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3)
MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171 NDA Pharmacosmos Therapeutics Inc. 73594-9305 73594-9305-1 1 VIAL in 1 BOX (73594-9305-1) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength100MG/ML (100MG/ML)
Approval Date:Jan 16, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 25, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 22, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IRON DEFICIENCY ANEMIA (DIA) IN ADULTS PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
Patent:⤷  Sign UpPatent Expiration:Mar 25, 2029Product Flag?YSubstance Flag?YDelist Request?

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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 verification 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.