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Last Updated: April 25, 2024

~ Buy the MONOFERRIC (ferric derisomaltose) Drug Profile, 2024 PDF Report in the Report Store ~

MONOFERRIC Drug Patent 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 three patents protecting this drug.

This drug has fifty-nine 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.

DrugPatentWatch® 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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  Try a Trial

Summary for MONOFERRIC
International Patents:59
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 10
Drug Prices: Drug price information for MONOFERRIC
What excipients (inactive ingredients) are in MONOFERRIC?MONOFERRIC excipients list
DailyMed Link:MONOFERRIC at DailyMed
Drug patent expirations by year for MONOFERRIC
Drug Prices for MONOFERRIC

See drug prices for MONOFERRIC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for MONOFERRIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Oregon Health and Science UniversityEarly Phase 1
Alberta Health Services, CalgaryPhase 3
AHS Cancer Control AlbertaPhase 3

See all MONOFERRIC clinical trials

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MONOFERRIC is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MONOFERRIC

Stable iron oligosaccharide compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

Stable iron oligosaccharide compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT 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

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

International Patents for MONOFERRIC

When does loss-of-exclusivity occur for MONOFERRIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09342799
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0924653
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 56580
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2361651
Estimated Expiration: ⤷  Try a Trial

Patent: 8752395
Estimated Expiration: ⤷  Try a Trial

Patent: 9700828
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170230
Estimated Expiration: ⤷  Try a Trial

Patent: 0201903
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18725
Estimated Expiration: ⤷  Try a Trial

Patent: 23651
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3917
Estimated Expiration: ⤷  Try a Trial

Patent: 1190214
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

Patent: 21910
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 64138
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 30866
Estimated Expiration: ⤷  Try a Trial

Patent: 52617
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 26010
Estimated Expiration: ⤷  Try a Trial

Patent: 12521369
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11009936
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5597
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015500891
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 700
Estimated Expiration: ⤷  Try a Trial

Patent: 104
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 11053
Estimated Expiration: ⤷  Try a Trial

Patent: 56075
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1107431
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1580348
Estimated Expiration: ⤷  Try a Trial

Patent: 120016063
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 17658
Estimated Expiration: ⤷  Try a Trial

Patent: 40074
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 3373
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MONOFERRIC around the world.

Country Patent Number Title Estimated Expiration
Slovenia 3156075 ⤷  Try a Trial
Spain 2840074 ⤷  Try a Trial
European Patent Office 3156075 OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF) ⤷  Try a Trial
Denmark 3156075 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MONOFERRIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2411053 C02411053/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FERRUM (III) UT FERRI ISOMALTOSIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67001 26.08.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.