Details for New Drug Application (NDA): 210192
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NDA 210192 describes JULUCA, which is a drug marketed by Viiv Hlthcare 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 JULUCA profile page.
The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; rilpivirine hydrochloride profile page.
The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; rilpivirine hydrochloride profile page.
Summary for 210192
| Tradename: | JULUCA |
| Applicant: | Viiv Hlthcare |
| Ingredient: | dolutegravir sodium; rilpivirine hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210192
Generic Entry Date for 210192*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 210192
Suppliers and Packaging for NDA: 210192
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192 | NDA | ViiV Healthcare Company | 49702-242 | 49702-242-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE;EQ 25MG BASE | ||||
| Approval Date: | Nov 21, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,426,780 | Patent Expiration: | Jan 24, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
| Patent: | 12,011,506 | Patent Expiration: | Sep 5, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,125,879 | Patent Expiration: | Apr 21, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
Expired US Patents for NDA 210192
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 6,838,464 | ⤷ Subscribe |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 8,101,629 | ⤷ Subscribe |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 8,080,551 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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