Details for New Drug Application (NDA): 205551
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NDA 205551 describes TRIUMEQ, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRIUMEQ profile page.
The generic ingredient in TRIUMEQ is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.
The generic ingredient in TRIUMEQ is abacavir sulfate; dolutegravir sodium; lamivudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; dolutegravir sodium; lamivudine profile page.
Summary for 205551
| Tradename: | TRIUMEQ |
| Applicant: | Viiv Hlthcare |
| Ingredient: | abacavir sulfate; dolutegravir sodium; lamivudine |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205551
Generic Entry Date for 205551*:
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: 205551
Suppliers and Packaging for NDA: 205551
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551 | NDA | ViiV Healthcare Company | 49702-231 | 49702-231-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-231-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE;EQ 50MG BASE;300MG | ||||
| Approval Date: | Aug 22, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860 | ||||||||
| Regulatory Exclusivity Expiration: | Dec 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 5, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 205551
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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