Details for New Drug Application (NDA): 215499
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NDA 215499 describes APRETUDE, which is a drug marketed by Viiv Hlthcare 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 APRETUDE profile page.
The generic ingredient in APRETUDE is cabotegravir. One supplier is listed for this compound. Additional details are available on the cabotegravir profile page.
The generic ingredient in APRETUDE is cabotegravir. One supplier is listed for this compound. Additional details are available on the cabotegravir profile page.
Summary for 215499
| Tradename: | APRETUDE |
| Applicant: | Viiv Hlthcare |
| Ingredient: | cabotegravir |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215499
Generic Entry Date for 215499*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*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: 215499
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-264 | 49702-264-23 | 1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03) |
| APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-280 | 49702-280-63 | 1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 600MG/3ML (200MG/ML) | ||||
| Approval Date: | Dec 20, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 28, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Subscribe | Patent Expiration: | Sep 15, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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