Skip to Content

Generic Ofev Availability

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

OFEV (nintedanib esylate - capsule;oral)

Has a generic version of Ofev been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ofev. 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: Generic Drug FAQs.

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.

  • Pharmaceutical dosage form for immediate release of an indolinone derivative
    Patent 10,105,323
    Issued: October 23, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to a pharmaceutical dosage form delivering an immediate release profile containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate.

    Patent expiration dates:

    • June 4, 2029
      ✓ 
      Drug product
  • Medicaments for the treatment or prevention of fibrotic diseases
    Patent 10,154,990
    Issued: December 18, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to the use of indolinones of general formula substituted in the 6 position, wherein R1 to R5 and X are defined as in claim 1, the isomers and the salts thereof, particularly the physiologically acceptable salts thereof, as a medicament for the prevention or treatment of specific fibrotic diseases.

    Patent expiration dates:

    • December 20, 2025
      ✓ 
      Patent use: USE OF NINTEDANIB FOR SLOWING THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
  • Substituted indolines which inhibit receptor tyrosine kinases
    Patent 6,762,180
    Issued: July 13, 2004
    Inventor(s): Gerald Juergen; Roth & Armin; Heckel & Rainer; Walter & Jacobus; Van Meel & Norbert; Redemann & Ulrike; Tontsch-Grunt & Walter; Spevak & Frank; Hilberg
    Assignee(s): Boehringer Ingelheim Pharma KG

    Indolinones of the formula having an inhibitory effect on receptor tyrosine kinases and cyclin/CDK complexes, as well as on the proliferation of endothelial cells and various tumor cells. Exemplary are: (a) 3-Z-[1-(4-(piperidin-1-yl-methyl)-anilino)-1-phenyl-methylene]-6-ethoxycarbonyl-2-indolinone, (b) 3-Z-[(1-(4-(piperidin-1-yl-methyl)-anilino)-1-phenyl-methylene]-6-carbamoyl-2-indolinone, and (c) 3-Z-[1-(4-(piperidin-1-yl-methyl)-anilino)-1-phenyl-methylene]-6-metboxycarbonyl-2-indolinone.

    Patent expiration dates:

    • October 3, 2020
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate and the use thereof as a pharmaceutical composition
    Patent 7,119,093
    Issued: October 10, 2006
    Inventor(s): Roth; Gerald J. & Linz; Guenter & Sieger; Peter & Rall; Werner & Hilberg; Frank & Bock; Thomas
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG

    The present invention relates to the compound 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycabonyl-2-indolinone-monoethanesulphonate of formula I and the use thereof as a pharmaceutical composition

    Patent expiration dates:

    • February 21, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
    Patent 9,907,756
    Issued: March 6, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The present invention relates to a suspension formulation containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate, to a capsule pharmaceutical dosage form containing said suspension formulation, to a process for preparing said suspension formulation, to a process for preparing said capsule comprising said suspension formulation and to the packaging material for the finished capsule.

    Patent expiration dates:

    • June 7, 2029
      ✓ 
      Drug product

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:

    • October 15, 2021 - TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
    • September 6, 2022 - SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE
    • March 9, 2023 - TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE
    • September 6, 2026 -

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.