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Last Updated: May 26, 2020

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MONOFERRIC Drug Profile


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Which patents cover Monoferric, and when can generic versions of Monoferric launch?

Monoferric is a drug marketed by Pharmacosmos As and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty-five countries.

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.

US ANDA Litigation and Generic Entry Outlook for Monoferric

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MONOFERRIC
International Patents:31
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:MONOFERRIC at DailyMed
Drug patent expirations by year for MONOFERRIC
Generic Entry Opportunity Date for MONOFERRIC
Generic Entry Date for MONOFERRIC*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for MONOFERRIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-003 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-002 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-001 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-001 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Colorcon
Mallinckrodt
Johnson and Johnson
Harvard Business School

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.