Varubi is a drug owned by Tersera Therapeutics Llc. It is protected by 10 US drug patents filed from 2015 to 2018. Out of these, 8 drug patents are active and 2 have expired. Varubi's patents have been open to challenges since 02 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 14, 2032. Details of Varubi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7049320 | NK1 antagonists |
Aug, 2028
(3 years from now) | Active |
| US8178550 | Hydrochloride salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy)-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and preparation process therefor |
Apr, 2027
(2 years from now) | Active |
| US7049230 | Method of forming a contact plug in a semiconductor device |
Dec, 2023
(11 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9101615 | Intravenous formulations of neurokinin-1 antagonists |
Jul, 2032
(7 years from now) | Active |
| US8361500 | Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom |
Oct, 2029
(4 years from now) | Active |
| US8470842 | Hydrochloride salts of 8-[{1-(3,5-Bis-trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and preparation process therefor |
Jan, 2029
(4 years from now) | Active |
| US8404702 | Pharmaceutical formulations:salts of 8-[1-3,5-bis-(trifluoromethyl)phenyl)-ethoxymethyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same |
Apr, 2027
(2 years from now) | Active |
| US7981905 | Pharmaceutical formulations: salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-Ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same |
Apr, 2027
(2 years from now) | Active |
| US7563801 | Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same |
Apr, 2027
(2 years from now) | Active |
| US8796299 | NK1 antagonists |
Dec, 2022
(1 year, 11 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Varubi's patents.
Latest Legal Activities on Varubi's Patents
Given below is the list of recent legal activities going on the following patents of Varubi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Nov, 2023 | US8178550 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Feb, 2023 | US9101615 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Jan, 2023 | US7981905 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2022 | US8796299 |
| Patent Term Extension Certificate Critical | 19 Nov, 2021 | US7049320 |
| Notice of Final Determination -Eligible | 04 Mar, 2021 | US7049320 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Sep, 2020 | US8470842 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Sep, 2020 | US7563801 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8404702 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Jul, 2020 | US8361500 |
FDA has granted several exclusivities to Varubi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Varubi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Varubi.
Exclusivity Information
Varubi holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Varubi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 01, 2020 |
Several oppositions have been filed on Varubi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Varubi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Varubi patents.
Varubi's Oppositions Filed in EPO
Varubi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 08, 2017, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP07774640A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP07774640A | Mar, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Varubi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Varubi's family patents as well as insights into ongoing legal events on those patents.
Varubi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Varubi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 14, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Varubi Generics:
There are no approved generic versions for Varubi as of now.
About Varubi
Varubi is a drug owned by Tersera Therapeutics Llc. It is used for prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy. Varubi uses Rolapitant Hydrochloride as an active ingredient. Varubi was launched by Tersera in 2017.
Approval Date:
Varubi was approved by FDA for market use on 25 October, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Varubi is 25 October, 2017, its NCE-1 date is estimated to be 02 September, 2019.
Active Ingredient:
Varubi uses Rolapitant Hydrochloride as the active ingredient. Check out other Drugs and Companies using Rolapitant Hydrochloride ingredient
Treatment:
Varubi is used for prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy.
Dosage:
Varubi is available in the following dosage forms - emulsion form for intravenous use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | EMULSION | Discontinued | INTRAVENOUS |
| EQ 90MG BASE | TABLET | Prescription | ORAL |