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 and is included in one NDA. There are five 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MONOFERRIC?
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Summary for MONOFERRIC
International Patents: | 59 |
US Patents: | 5 |
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 five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MONOFERRIC is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable iron oligosaccharide compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-003 | Jan 16, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pharmacosmos | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-001 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pharmacosmos | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-003 | Jan 16, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pharmacosmos | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-002 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pharmacosmos | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-001 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pharmacosmos | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-002 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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
Patent: A stable iron oligosaccharide compound
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0924653
Patent: composto de ferro-oligossacarídeo estável
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 56580
Patent: COMPOSE OLIGOSACCHARIDE STABLE ASSOCIE AU FER (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2361651
Patent: Stable iron oligosaccharide compound
Estimated Expiration: ⤷ Sign Up
Patent: 8752395
Patent: 稳定的铁寡糖复合物 (Stable iron oligosaccharide complex)
Estimated Expiration: ⤷ Sign Up
Patent: 9700828
Patent: 稳定的铁寡糖复合物 (Stable iron oligosaccharide compound)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0170230
Estimated Expiration: ⤷ Sign Up
Patent: 0201903
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18725
Estimated Expiration: ⤷ Sign Up
Patent: 23651
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 11053
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3917
Patent: СТАБИЛЬНОЕ ЖЕЛЕЗО - ОЛИГОСАХАРИДНОЕ СОЕДИНЕНИЕ (STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
Patent: 1190214
Patent: СТАБИЛЬНОЕ ЖЕЛЕЗО-ОЛИГОСАХАРИДНОЕ СОЕДИНЕНИЕ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 11053
Patent: COMPOSÉ OLIGOSACCHARIDE STABLE ASSOCIÉ AU FER (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Patent: OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 21910
Patent: OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 64138
Patent: 穩定的鐵寡糖複合物 (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30866
Estimated Expiration: ⤷ Sign Up
Patent: 52617
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 26010
Estimated Expiration: ⤷ Sign Up
Patent: 12521369
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 11053
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11009936
Patent: UN COMPUESTO DE OLIGOSACARIDO DE HIERRO ESTABLE. (A STABLE IRON OLIGOSACCHARIDE COMPOUND.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5597
Patent: A STABLE IRON OLIGOSACCHARIDE COMPOUND
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 015500891
Patent: A STABLE IRON OLIGOSACCHARIDE COMPOUND
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 11053
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 11053
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 700
Patent: STABILNO JEDINJENJE GVOŽĐA I OLIGOSAHARIDA (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
Patent: 104
Patent: OLIGOSAHARID I POSTUPAK NJEGOVE PRIPREME (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 11053
Estimated Expiration: ⤷ Sign Up
Patent: 56075
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1107431
Patent: A STABLE IRON OLIGOSACCHARIDE COMPOUND
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1580348
Estimated Expiration: ⤷ Sign Up
Patent: 120016063
Patent: A STABLE IRON OLIGOSACCHARIDE COMPOUND
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 17658
Estimated Expiration: ⤷ Sign Up
Patent: 40074
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3373
Patent: СТАБИЛЬНОЕ СОЕДИНЕНИЕ ФЕРРУМА ОЛИГОСАХАРИДА;СТАБІЛЬНА СПОЛУКА ФЕРУМУ ОЛІГОСАХАРИДУ (STABLE IRON OLIGOSACCHARIDE COMPOUND)
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
Lithuania | 2411053 | ⤷ Sign Up | |
European Patent Office | 3821910 | OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF) | ⤷ Sign Up |
China | 108752395 | 稳定的铁寡糖复合物 (Stable iron oligosaccharide complex) | ⤷ Sign Up |
South Korea | 101580348 | ⤷ Sign Up | |
European Patent Office | 2411053 | COMPOSÉ OLIGOSACCHARIDE STABLE ASSOCIÉ AU FER (A STABLE IRON OLIGOSACCHARIDE COMPOUND) | ⤷ Sign Up |
Spain | 2892488 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | 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 |