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Generic Esbriet Availability

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

ESBRIET (pirfenidone - capsule;oral)

  • Manufacturer: GENENTECH INC
    Approval date: October 15, 2014
    Strength(s): 267MG [RLD]

Has a generic version of Esbriet been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Esbriet. 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.

  • Modifying pirfenidone treatment for patients with atypical liver function
    Patent 7,566,729
    Issued: July 28, 2009
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage.
    Patent expiration dates:
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
  • Pirfenidone treatment for patients with atypical liver function
    Patent 7,635,707
    Issued: December 22, 2009
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
    Patent expiration dates:
    • April 22, 2029
      ✓ 
      Patent use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
  • Method of providing pirfenidone therapy to a patient
    Patent 7,696,236
    Issued: April 13, 2010
    Inventor(s): Bradford; Williamson Z.
    Assignee(s): InterMune, Inc.
    The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
    Patent expiration dates:
    • December 18, 2027
      ✓ 
      Patent use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
  • Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
    Patent 7,767,225
    Issued: August 3, 2010
    Inventor(s): Radhakrishnan; Ramachandran & Vladyka; Ronald & Sultzbaugh; Kenneth
    Assignee(s): Intermune, Inc.
    A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
    Patent expiration dates:
    • September 22, 2026
      ✓ 
      Patent use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
      ✓ 
      Drug product
  • Method of providing pirfenidone therapy to a patient
    Patent 7,767,700
    Issued: August 3, 2010
    Inventor(s): Bradford; Williamson Ziegler
    Assignee(s): Intermune, Inc.
    The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
    Patent expiration dates:
    • December 18, 2027
      ✓ 
      Patent use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
  • Methods of administering pirfenidone therapy
    Patent 7,816,383
    Issued: October 19, 2010
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
  • Methods of administering pirfenidone therapy
    Patent 7,910,610
    Issued: March 22, 2011
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2
  • Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
    Patent 7,988,994
    Issued: August 2, 2011
    Inventor(s): Radhakrishnan; Ramachandran & Vladyka; Ronald & Sultzbaugh; Kenneth
    Assignee(s): Intermune, Inc.
    A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
    Patent expiration dates:
    • September 22, 2026
      ✓ 
      Patent use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
      ✓ 
      Drug product
  • Methods of administering pirfenidone therapy
    Patent 8,013,002
    Issued: September 6, 2011
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
  • Pirfenidone therapy and inducers of cytochrome P450
    Patent 8,084,475
    Issued: December 27, 2011
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
  • Methods of administering pirfenidone therapy
    Patent 8,318,780
    Issued: November 27, 2012
    Inventor(s): Bradford; Williamson Ziegler & Szwarcberg; Javier
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with fluvoxamine and pirfenidone or other moderate to strong inhibitors of CYP enzymes.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
  • Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
    Patent 8,383,150
    Issued: February 26, 2013
    Assignee(s): Intermune, Inc.
    A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
    Patent expiration dates:
    • September 22, 2026
      ✓ 
      Patent use: METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF PIRFENIDONE TO TREAT A FIBROTIC CONDITION
      ✓ 
      Drug product
  • Method of providing pirfenidone therapy to a patient
    Patent 8,420,674
    Issued: April 16, 2013
    Assignee(s): Intermune, Inc.
    The invention relates to methods for decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.
    Patent expiration dates:
    • December 18, 2027
      ✓ 
      Patent use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
      ✓ 
      Drug product
  • Pirfenidone treatment for patients with atypical liver function
    Patent 8,592,462
    Issued: November 26, 2013
    Assignee(s): Intermune, Inc.
    Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
    Patent expiration dates:
    • April 22, 2029
      ✓ 
      Patent use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
  • Pirfenidone treatment for patients with atypical liver function
    Patent 8,609,701
    Issued: December 17, 2013
    Assignee(s): Intermune, Inc.
    Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
    Patent expiration dates:
    • April 22, 2029
      ✓ 
      Patent use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE
  • Pirfenidone therapy and inducers of cytochrome P450
    Patent 8,648,098
    Issued: February 11, 2014
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
  • Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
    Patent 8,753,679
    Issued: June 17, 2014
    Assignee(s): Intermune, Inc.
    A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
    Patent expiration dates:
    • September 22, 2026
      ✓ 
      Patent use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
      ✓ 
      Drug product
  • Pirfenidone therapy and inducers of cytochrome P450
    Patent 8,754,109
    Issued: June 17, 2014
    Assignee(s): Intermune, Inc.
    The present invention relates to methods involving avoiding adverse drug interactions with pirfenidone and CYP inducers, such as smoking.
    Patent expiration dates:
    • January 8, 2030
      ✓ 
      Patent use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
  • Methods of administering pirfenidone therapy
    Patent 8,778,947
    Issued: July 15, 2014
    Assignee(s): Intermune, Inc.
    The disclosure relates to improved methods of administering pirfenidone therapy when ciprofloxacin is administered concomitantly.
    Patent expiration dates:
    • August 30, 2033
      ✓ 
      Patent use: DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN

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 16, 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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