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Generic Varubi Availability

Varubi is a brand name of rolapitant, approved by the FDA in the following formulation(s):

VARUBI (rolapitant hydrochloride - tablet;oral)

  • Manufacturer: TESARO INC
    Approval date: September 1, 2015
    Strength(s): EQ 90MG BASE [RLD]

Has a generic version of Varubi been approved?

No. There is currently no therapeutically equivalent version of Varubi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Varubi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • NK1 antagonists
    Patent 7,049,320
    Issued: May 23, 2006
    Inventor(s): Paliwal; Sunil & Reichard; Gregory A. & Wang; Cheng & Xiao; Dong & Tsui; Hon-Chung & Shih; Neng-Yang & Arredondo; Juan D. & Wrobleski; Michelle Laci & Palani; Anandan
    Assignee(s): Schering Corporation
    A NK1 antagonist having the formula (I), wherein Ar1 and Ar2 are optionally substituted phenyl or heteroaryl, X1 is an ether, thio or imino linkage, R4 and R5 are not both H or alkyl, and the remaining variables are as defined in the specification, useful for treating a number of disorders, including emesis, depression, anxiety and cough. Pharmaceutical compositions. Methods of treatment and combinations with other agents are also disclosed.
    Patent expiration dates:
    • December 8, 2023
      ✓ 
      Patent use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 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
    Patent 7,563,801
    Issued: July 21, 2009
    Inventor(s): Qiu; Zhihui & Reyderman; Larisa
    Assignee(s): Schering Corporation
    Pharmaceutical formulations containing salts of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro [4.5]decan-2-one, represented by Formula I, are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
    Patent expiration dates:
    • April 4, 2027
      ✓ 
      Drug product
  • 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
    Patent 7,981,905
    Issued: July 19, 2011
    Inventor(s): Qiu; Zhihui & Reyderman; Larisa
    Assignee(s): OPKO Health, Inc.
    Pharmaceutical formulations containing salts of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
    Patent expiration dates:
    • April 4, 2027
      ✓ 
      Patent use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
  • 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
    Patent 8,178,550
    Issued: May 15, 2012
    Inventor(s): Hu; Mengwei & Paliwal; Sunil & Shih; Neng-Yang & Guenter; Frank Bruno & Mergelsberg; Ingrid
    Assignee(s): OPKO Health, Inc.
    Disclosed are hydrochloride and tosylate crystalline salt forms of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I and methods of preparing the same.
    Patent expiration dates:
    • April 4, 2027
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 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
    Patent 8,361,500
    Issued: January 29, 2013
    Assignee(s): Opko Health, Inc.
    Pharmaceutical formulations containing a salt of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, which are suitable for forming into a tablet dosage form, as well as tablet dosage forms are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
    Patent expiration dates:
    • October 9, 2029
      ✓ 
      Drug product
  • 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
    Patent 8,404,702
    Issued: March 26, 2013
    Assignee(s): Opko Health, Inc.
    Pharmaceutical formulations containing salts of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
    Patent expiration dates:
    • October 9, 2029
      ✓ 
      Patent use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
  • 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
    Patent 8,470,842
    Issued: June 25, 2013
    Assignee(s): OPKO Health, Inc.
    Disclosed are hydrochloride and tosylate crystalline salt forms of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I and methods of preparing the same.
    Patent expiration dates:
    • January 18, 2029
      ✓ 
      Patent use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY
  • NK1 antagonists
    Patent 8,796,299
    Issued: August 5, 2014
    Assignee(s): OPKO Health, Inc.
    A NK1 antagonist having the formula (I), wherein Ar1 and Ar2 are optionally substituted phenyl or heteroaryl, X1 is an ether, thio or imino linkage, R4 and R5 are not both H or alkyl, and the remaining variables are as defined in the specification, useful for treating a number of disorders, including emesis, depression, anxiety and cough. Pharmaceutical compositions. Methods of treatment and combinations with other agents are also disclosed.
    Patent expiration dates:
    • December 17, 2022
      ✓ 
      Patent use: PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH EMETOGENIC CANCER CHEMOTHERAPY

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • September 1, 2020 - NEW CHEMICAL ENTITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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