MONOFERRIC Drug Patent Profile
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When do Monoferric patents expire, and what generic alternatives are available?
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
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 |
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
Sponsor | Phase |
---|---|
Oregon Health and Science University | Early Phase 1 |
Alberta Health Services, Calgary | Phase 3 |
AHS Cancer Control Alberta | Phase 3 |
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 |
---|---|---|---|
South Korea | 101580348 | ⤷ Try a Trial | |
Hungary | E030866 | ⤷ Try a Trial | |
Japan | 2012521369 | ⤷ Try a Trial | |
European Patent Office | 3821910 | OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF) | ⤷ 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 |