Details for New Drug Application (NDA): 022408
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NDA 022408 describes NATROBA, which is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the NATROBA profile page.
The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the spinosad profile page.
The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the spinosad profile page.
Summary for 022408
| Tradename: | NATROBA |
| Applicant: | Parapro Llc |
| Ingredient: | spinosad |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022408
Generic Entry Date for 022408*:
Constraining patent/regulatory exclusivity:
FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER Dosage:
SUSPENSION;TOPICAL |
*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.
Pharmacology for NDA: 022408
Suppliers and Packaging for NDA: 022408
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NATROBA | spinosad | SUSPENSION;TOPICAL | 022408 | NDA AUTHORIZED GENERIC | Allegis Pharmaceuticals, LLC | 28595-570 | 28595-570-04 | 1 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) / 120 mL in 1 BOTTLE, PLASTIC |
| NATROBA | spinosad | SUSPENSION;TOPICAL | 022408 | NDA AUTHORIZED GENERIC | ParaPRO LLC | 52246-570 | 52246-570-04 | 1 BOTTLE, PLASTIC in 1 CARTON (52246-570-04) / 120 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;TOPICAL | Strength | 0.9% | ||||
| Approval Date: | Jan 18, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 28, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 25, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | THE PRODUCT COMPOSITION (NATROBA) IS FOR THE TOPICAL TREATMENT OF HUMAN SCABIES MITE INFESTATIONS BY MELTING AND DELIVERING THE ACTIVE INGREDIENT, SPINOSAD, TO THE STRATUM CORNEUM WHERE SCABIES MITES LIVE AND BREED | ||||||||
Expired US Patents for NDA 022408
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Parapro Llc | NATROBA | spinosad | SUSPENSION;TOPICAL | 022408-001 | Jan 18, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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