Details for New Drug Application (NDA): 206500
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The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
Summary for 206500
Tradename: | VARUBI |
Applicant: | Tersera |
Ingredient: | rolapitant hydrochloride |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206500
Generic Entry Date for 206500*:
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: 206500
Suppliers and Packaging for NDA: 206500
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500 | NDA | TerSera Therapeutics LLC | 70720-101 | 70720-101-02 | 2 TABLET in 1 BLISTER PACK (70720-101-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Sep 1, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 19, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 4, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 4, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY |
Expired US Patents for NDA 206500
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500-001 | Sep 1, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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