Details for New Drug Application (NDA): 205551
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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: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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