Details for New Drug Application (NDA): 208171
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NDA 208171 describes MONOFERRIC, which is a drug marketed by Pharmacosmos As and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MONOFERRIC profile page.
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.
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.
Summary for 208171
| Tradename: | MONOFERRIC |
| Applicant: | Pharmacosmos As |
| Ingredient: | ferric derisomaltose |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208171
Generic Entry Date for 208171*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 208171
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171 | NDA | Pharmacosmos Therapeutics Inc. | 73594-9301 | 73594-9301-2 | 5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3) |
| MONOFERRIC | ferric derisomaltose | SOLUTION;INTRAVENOUS | 208171 | NDA | Pharmacosmos Therapeutics Inc. | 73594-9305 | 73594-9305-1 | 1 VIAL in 1 BOX (73594-9305-1) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/ML (100MG/ML) | ||||
| Approval Date: | Jan 16, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 25, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 22, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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: | ⤷ Try a Trial | Patent Expiration: | Aug 14, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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 | ||||||||
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