FERRIC DERISOMALTOSE - Generic Drug Details
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What are the generic sources for ferric derisomaltose and what is the scope of freedom to operate?
Ferric derisomaltose
is the generic ingredient in one branded drug marketed by Pharmacosmos As and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ferric derisomaltose has fifty-nine patent family members in twenty-five countries.
One supplier is listed for this compound.
Summary for FERRIC DERISOMALTOSE
| International Patents: | 59 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 22 |
| Patent Applications: | 6 |
| What excipients (inactive ingredients) are in FERRIC DERISOMALTOSE? | FERRIC DERISOMALTOSE excipients list |
| DailyMed Link: | FERRIC DERISOMALTOSE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FERRIC DERISOMALTOSE
*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 FERRIC DERISOMALTOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Hospital Los Angeles | Phase 4 |
| China-Japan Friendship Hospital | Phase 4 |
| Oregon Health and Science University | Early Phase 1 |
US Patents and Regulatory Information for 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 | 208171-002 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pharmacosmos As | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-001 | Jan 16, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pharmacosmos As | MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171-003 | Jan 16, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pharmacosmos As | 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 FERRIC DERISOMALTOSE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2022169561 | 胎児又は小児の鉄欠乏症の治療のための鉄炭水化物複合体 | ⤷ Sign Up |
| South Korea | 101580348 | ⤷ Sign Up | |
| European Patent Office | 3821910 | OLIGOSIDE ET SON PROCÉDÉ DE PRÉPARATION (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF) | ⤷ Sign Up |
| China | 109700828 | 稳定的铁寡糖复合物 (Stable iron oligosaccharide compound) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FERRIC DERISOMALTOSE
| 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 |
