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Last Updated: September 25, 2022

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 two patents protecting this drug.

This drug has forty-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. 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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Summary for MONOFERRIC
International Patents:41
US Patents:2
Applicants:1
NDAs:1
Clinical Trials: 9
What excipients (inactive ingredients) are in MONOFERRIC?MONOFERRIC excipients list
DailyMed Link:MONOFERRIC at DailyMed
Drug patent expirations by year for MONOFERRIC
DrugPatentWatch® Estimated 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.

Recent Clinical Trials for MONOFERRIC

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

SponsorPhase
Alberta Health Services, CalgaryPhase 3
AHS Cancer Control AlbertaPhase 3
University of MichiganPhase 3

See all MONOFERRIC clinical trials

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MONOFERRIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable iron oligosaccharide compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-001 Jan 16, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-003 Jan 16, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacosmos As MONOFERRIC ferric derisomaltose SOLUTION;INTRAVENOUS 208171-001 Jan 16, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 0924653
Estimated Expiration: See Plans and Pricing

Canada

Patent: 56580
Estimated Expiration: See Plans and Pricing

China

Patent: 2361651
Estimated Expiration: See Plans and Pricing

Patent: 8752395
Estimated Expiration: See Plans and Pricing

Patent: 9700828
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170230
Estimated Expiration: See Plans and Pricing

Patent: 0201903
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18725
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3917
Estimated Expiration: See Plans and Pricing

Patent: 1190214
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

Patent: 21910
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 64138
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30866
Estimated Expiration: See Plans and Pricing

Patent: 52617
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26010
Estimated Expiration: See Plans and Pricing

Patent: 12521369
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11009936
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5597
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015500891
Estimated Expiration: See Plans and Pricing

Poland

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 700
Estimated Expiration: See Plans and Pricing

Patent: 104
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 11053
Estimated Expiration: See Plans and Pricing

Patent: 56075
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1107431
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1580348
Estimated Expiration: See Plans and Pricing

Patent: 120016063
Estimated Expiration: See Plans and Pricing

Spain

Patent: 17658
Estimated Expiration: See Plans and Pricing

Patent: 40074
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3373
Estimated Expiration: See Plans and Pricing

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
Croatia P20201903 See Plans and Pricing
Hungary E030866 See Plans and Pricing
China 109700828 稳定的铁寡糖复合物 (Stable iron oligosaccharide compound) See Plans and Pricing
Portugal 2411053 See Plans and Pricing
>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 See Plans and Pricing 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

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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.