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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]

ESBRIET (pirfenidone - tablet;oral)

  • Manufacturer: GENENTECH INC
    Approval date: January 11, 2017
    Strength(s): 267MG [RLD], 534MG [RLD], 801MG [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: 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.

  • 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
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
  • 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
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
  • 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
    • December 18, 2027
      ✓ 
      Patent use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
  • 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
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
  • 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
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
  • 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
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
    • January 8, 2030
      ✓ 
      Patent use: MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE 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
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
  • 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
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
  • 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
    • December 18, 2027
      ✓ 
      Patent use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
  • 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
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
    • April 22, 2029
      ✓ 
      Patent use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
  • 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
    • April 22, 2029
      ✓ 
      Patent use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
    • April 22, 2029
      ✓ 
      Patent use: DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
    • April 22, 2029
      ✓ 
      Patent use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
  • 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
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
    • January 8, 2030
      ✓ 
      Patent use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
  • 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
    • January 8, 2030
      ✓ 
      Patent use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
  • 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
    • August 30, 2033
      ✓ 
      Patent use: ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
    • August 30, 2033
      ✓ 
      Patent use: DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
  • Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
    Patent 9,561,217
    Issued: February 7, 2017
    Assignee(s): INTERMUNE, INC.
    A tablet characterized by comprising 5-methyl-1-phenyl-2-(1H)-pyridone as the main ingredient and, based on the main ingredient, 10 to 50 wt. % excipient, 5 to 40 wt. % disintegrator, 1 to 10 wt. % binder, 0.5 to 5 wt. % lubricant, 2 to 6 wt. % coating basis, and 0.05 to 3 wt. % light-shielding agent, wherein the odor or bitterness of the 5-methyl-1-phenyl-2-(1H)-pyridone is masked and the light stability is improved.
    Patent expiration dates:
    • January 25, 2022
      ✓ 
      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, 2019 - NEW CHEMICAL ENTITY
    • October 15, 2021 - TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
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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