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Generic Ofev Availability

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

OFEV (nintedanib esylate - capsule;oral)

  • Manufacturer: BOEHRINGER INGELHEIM
    Approval date: October 15, 2014
    Strength(s): EQ 100MG BASE, 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: 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.

  • 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:
    • December 10, 2020
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  • 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
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  • Use of Lck inhibitors for treatment of immunologic diseases
    Patent 7,989,474
    Issued: August 2, 2011
    Inventor(s): Roth; Gerald Juergen & Heckel; Armin & Walter; Rainer & Hilberg; Frank & Hauptmann; Rudolf & Stefanic; Martin Fredrich & Colbatzky; Florian & Ernest; Steffan
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG
    The invention relates to a method of treating immunologic diseases or pathological conditions involving an immunologic component using certain Lck inhibitors already known as kinase inhibitors for therapy in oncology, optionally in combination with one or more other drugs selected from NSAIDs, steroids, DMARDs, immunsuppressives, biologic response modifiers and antinfectives, pharmaceutical compositions comprising said Lck inhibitors together with said other drugs, and the use of the Lck inhibitors for the manufacture of a pharmaceutical composition for the treatment of immunologic diseases or pathological conditions involving an immunologic component.
    Patent expiration dates:
    • April 6, 2024
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      Patent use: TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS (IPF)

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, 2019 - NEW CHEMICAL ENTITY
    • October 15, 2021 - ORPHAN DRUG EXCLUSIVITY

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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