Generic Ofev Availability
Last updated on Sep 11, 2024.
Ofev is a brand name of nintedanib, approved by the FDA in the following formulation(s):
OFEV (nintedanib esylate - capsule;oral)
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Manufacturer: BOEHRINGER INGELHEIM
Approval date: October 15, 2014
Strength(s): EQ 100MG BASE [RLD], EQ 150MG BASE [RLD]
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 FAQ.
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.
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Pharmaceutical dosage form for immediate release of an indolinone derivative
Patent 10,105,323
Issued: October 23, 2018
Inventor(s): Messerschmid Roman & Lach Peter & Sokoliess Torsten & Stopfer Peter & Trommeshauser Dirk
Assignee(s): Boehringer Ingelheim International GmbHThe 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✓
- June 4, 2029
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Pharmaceutical dosage form for immediate release of an indolinone derivative
Patent 10105323*PE
Issued: October 23, 2018
Inventor(s): Messerschmid Roman & Lach Peter & Sokoliess Torsten & Stopfer Peter & Trommeshauser Dirk
Assignee(s): Boehringer Ingelheim International GmbHThe 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:
- December 4, 2029
- December 4, 2029
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Medicaments for the treatment or prevention of fibrotic diseases
Patent 10,154,990
Issued: December 18, 2018
Inventor(s): Park John Edward & Roth Gerald Juergen & Heckel Armin & Chaudhary Nveed & Brandl Trixi & Dahmann Georg & Grauert Matthias
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to the use of indolinones of general formula
Patent expiration dates:
- January 8, 2026✓
- January 8, 2026
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Medicaments for the treatment or prevention of fibrotic diseases
Patent 10154990*PE
Issued: December 18, 2018
Inventor(s): Park John Edward & Roth Gerald Juergen & Heckel Armin & Chaudhary Nveed & Brandl Trixi & Dahmann Georg & Grauert Matthias
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to the use of indolinones of general formula
Patent expiration dates:
- July 8, 2026
- July 8, 2026
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Patent 6,762,180
Patent expiration dates:
- October 1, 2025✓✓
- October 1, 2025
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Patent 6762180*PED
Patent expiration dates:
- April 1, 2026✓
- April 1, 2026
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Patent 7,119,093
Patent expiration dates:
- February 21, 2024✓✓
- February 21, 2024
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Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Patent 9,907,756
Issued: March 6, 2018
Inventor(s): Messerschmid Roman & Binder Rudolf & Bock Thomas & Brox Werner
Assignee(s): Boehringer Ingelheim International GmbHThe 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✓
- June 7, 2029
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Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Patent 9907756*PED
Issued: March 6, 2018
Inventor(s): Messerschmid Roman & Binder Rudolf & Bock Thomas & Brox Werner
Assignee(s): Boehringer Ingelheim International GmbHThe 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:
- December 7, 2029✓
- December 7, 2029
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 6, 2026 - INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
- March 6, 2027 - PEDIATRIC EXCLUSIVITY
More about Ofev (nintedanib)
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- Reviews (22)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
- Breastfeeding
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Glossary
Term | Definition |
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.