Details for New Drug Application (NDA): 212950
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The generic ingredient in RUKOBIA is fostemsavir tromethamine. One supplier is listed for this compound. Additional details are available on the fostemsavir tromethamine profile page.
Summary for 212950
Tradename: | RUKOBIA |
Applicant: | Viiv Hlthcare |
Ingredient: | fostemsavir tromethamine |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212950
Generic Entry Date for 212950*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.
Suppliers and Packaging for NDA: 212950
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950 | NDA | ViiV Healthcare Company | 49702-250 | 49702-250-18 | 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 600MG BASE | ||||
Approval Date: | Jul 2, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 2, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 19, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 25, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
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