Details for New Drug Application (NDA): 208030
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NDA 208030 describes FERRIPROX, which is a drug marketed by Chiesi and is included in three NDAs. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FERRIPROX profile page.
The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 208030
| Tradename: | FERRIPROX |
| Applicant: | Chiesi |
| Ingredient: | deferiprone |
| Patents: | 1 |
Pharmacology for NDA: 208030
| Mechanism of Action | Iron Chelating Activity |
Suppliers and Packaging for NDA: 208030
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FERRIPROX | deferiprone | SOLUTION;ORAL | 208030 | NDA | Chiesi USA, Inc. | 10122-101 | 10122-101-50 | 500 mL in 1 BOTTLE, PLASTIC (10122-101-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
| Approval Date: | Sep 9, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011 | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES | ||||||||
Expired US Patents for NDA 208030
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-002 | Apr 20, 2018 | 7,049,328 | ⤷ Get Started Free |
| Chiesi | FERRIPROX | deferiprone | SOLUTION;ORAL | 208030-001 | Sep 9, 2015 | 7,049,328 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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