Details for New Drug Application (NDA): 206966
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NDA 206966 describes XEGLYZE, which is a drug marketed by Hatchtech and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XEGLYZE profile page.
The generic ingredient in XEGLYZE is abametapir. One supplier is listed for this compound. Additional details are available on the abametapir profile page.
The generic ingredient in XEGLYZE is abametapir. One supplier is listed for this compound. Additional details are available on the abametapir profile page.
Summary for 206966
| Tradename: | XEGLYZE |
| Applicant: | Hatchtech |
| Ingredient: | abametapir |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206966
Generic Entry Date for 206966*:
Constraining patent/regulatory exclusivity:
Dosage:
LOTION;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.
Suppliers and Packaging for NDA: 206966
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XEGLYZE | abametapir | LOTION;TOPICAL | 206966 | NDA | Dr. Reddy's Laboratories Inc. | 43598-921 | 43598-921-11 | 1 BOTTLE in 1 CARTON (43598-921-11) / 200 g in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | LOTION;TOPICAL | Strength | 0.74% | ||||
| Approval Date: | Jul 24, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 28, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER | ||||||||
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