Details for New Drug Application (NDA): 213464
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NDA 213464 describes LAMPIT, which is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the LAMPIT profile page.
The generic ingredient in LAMPIT is nifurtimox. One supplier is listed for this compound. Additional details are available on the nifurtimox profile page.
The generic ingredient in LAMPIT is nifurtimox. One supplier is listed for this compound. Additional details are available on the nifurtimox profile page.
Summary for 213464
| Tradename: | LAMPIT |
| Applicant: | Bayer Healthcare |
| Ingredient: | nifurtimox |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213464
Generic Entry Date for 213464*:
Constraining patent/regulatory exclusivity:
INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI Dosage:
TABLET;ORAL |
*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: 213464
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAMPIT | nifurtimox | TABLET;ORAL | 213464 | NDA | Bayer Healthcare Pharmaceuticals INC. | 50419-750 | 50419-750-01 | 1 BOTTLE in 1 CARTON (50419-750-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
| LAMPIT | nifurtimox | TABLET;ORAL | 213464 | NDA | Bayer Healthcare Pharmaceuticals INC. | 50419-751 | 50419-751-01 | 1 BOTTLE in 1 CARTON (50419-751-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 6, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI | ||||||||
| Regulatory Exclusivity Expiration: | Aug 6, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Aug 6, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI | ||||||||
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