rolapitant Oral Tablet
- Brand(s)
- Varubi
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Tesaro, Inc. (2015-10-07)
- Oldest Current Product
- 2015-10-07
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ROLAPITANT
- FDAOB
- ORAL\TABLET\ROLAPITANT HYDROCHLORIDE
- SPL Active
- ORAL\TABLET\ROLAPITANT HYDROCHLORIDE
- SPL Moiety
- ORAL\TABLET\ROLAPITANT
product(s) by strength(s)
rolapitant 90 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 696560101 | Varubi | NDA | Tesaro, Inc. | 2015-10-07 | ROLAPITANT HYDROCHLORIDE | ORAL | TABLET | NDA206500 | ed3ef3f8-8cb7-40db-9d75-e728ee607760 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA206500 | VARUBI | TESARO INC | 2015-09-01 | p8178550, SUBSTANCE p7981905, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY/ ROLAPITANT IS APPROVED FOR THE PREVENTION OF DELAYED NAUSEA AND VOMITING (I.E. p8470842, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY p7049230, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY, SUBSTANCE p8404702, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY p8796299, PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY p7563801, SUBSTANCE p8361500, SUBSTANCE | NEW CHEMICAL ENTITY [2020-09-01] | NDA206500_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA206500_001 | RX | ROLAPITANT HYDROCHLORIDE (EQ 90MG BASE) | ORAL | TABLET | True | 2015-09-01 | VARUBI |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7049230 (view patent) | 2023-12-08 | NDA206500 |
| 2 | p7563801 (view patent) | 2027-04-04 | NDA206500 |
| 3 | p7981905 (view patent) | 2027-04-04 | NDA206500 |
| 4 | p8178550 (view patent) | 2027-04-04 | NDA206500 |
| 5 | p8361500 (view patent) | 2029-10-09 | NDA206500 |
| 6 | p8404702 (view patent) | 2029-10-09 | NDA206500 |
| 7 | p8470842 (view patent) | 2029-01-18 | NDA206500 |
| 8 | p8796299 (view patent) | 2022-12-17 | NDA206500 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | ed3ef3f8-8cb7-40db-9d75-e728ee607760 (view SPL) | These highlights do not include all the information needed to use VARUBI safely and effectively. See full prescribing information for VARUBI. VARUBI (rolapitant) tablets, for oral use Initial U.S. Approval: 2015 | prescription | Human Prescription | Tesaro, Inc. | 2015-10-07 | 3 | 696560101 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII