Varubi Patent Expiration

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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7049230 Method of forming a contact plug in a semiconductor device
Dec, 2023

(7 months ago)

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)

US7049320 NK1 antagonists
Aug, 2028

(4 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8796299 NK1 antagonists
Dec, 2022

(1 year, 7 months ago)

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)

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)

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)

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)

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

(5 years from now)

US9101615 Intravenous formulations of neurokinin-1 antagonists
Jul, 2032

(7 years from now)


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

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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
Patent litigations
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

Varubi has patent protection in a total of 35 countries. It's US patent count contributes only to 20.0% of its total global patent coverage. 17 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Varubi.

Family Patents

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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 2015.

Market Authorisation Date:

Varubi was approved by FDA for market use on 01 September, 2015.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Varubi is 01 September, 2015, 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


Varubi is used for prevention of delayed nausea and vomiting associated with emetogenic cancer chemotherapy.


Varubi is available in the following dosage forms - tablet form for oral use, emulsion form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway