Details for New Drug Application (NDA): 212950
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NDA 212950 describes RUKOBIA, 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 RUKOBIA profile page.
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.
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: | 7,745,625 | Patent Expiration: | Nov 19, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 8,168,615 | Patent Expiration: | Jul 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 212950
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | RUKOBIA | fostemsavir tromethamine | TABLET, EXTENDED RELEASE;ORAL | 212950-001 | Jul 2, 2020 | 8,461,333 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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