Details for New Drug Application (NDA): 206500
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NDA 206500 describes VARUBI, which is a drug marketed by Tersera and is included in two NDAs. It is available from two suppliers. There are eight patents protecting this drug. Additional details are available on the VARUBI profile page.
The generic ingredient in VARUBI is rolapitant hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.
The generic ingredient in VARUBI is rolapitant hydrochloride. There is one drug master file entry for this compound. Two suppliers are 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) |
| VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500 | NDA | Luria Therapeutics LLC | 87628-101 | 87628-101-02 | 2 TABLET in 1 BLISTER PACK (87628-101-02) |
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: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Apr 4, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | 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 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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