Thursday, 24 November 2011

Inspra


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


INSPRA (eplerenone - tablet; oral)



  • Manufacturer: GD SEARLE LLC

    Approval date: September 27, 2002

    Strength(s): 25MG [AB], 50MG [RLD][AB]

Has a generic version of Inspra been approved?


A generic version of Inspra has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Inspra and have been approved by the FDA:


eplerenone tablet; oral



  • Manufacturer: APOTEX

    Approval date: July 30, 2008

    Strength(s): 25MG [AB], 50MG [AB]


  • Manufacturer: SANDOZ

    Approval date: August 1, 2008

    Strength(s): 25MG [AB], 50MG [AB]

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




  • Immediate release eplerenone compositions
    Patent 6,410,054
    Issued: June 25, 2002
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease
    Patent 6,410,524
    Issued: June 25, 2002
    Inventor(s): Alfonzo T.; Perez & Debra J.; Asner & Richard J.; LaChapelle & John C.; Alexander & Barbara; Roniker
    Assignee(s): G. D. Searle & Co.
    Combinations of an ACE inhibitor, an aldosterone antagonist, and a loop diuretic are described for use in treatment of circulatory disorders. Of particular interest are therapies using captopril, enalapril or lisinopril co-administered with spironolactone. This co-therapy would be particularly useful to reduce the death rate or the number of non-fatal hospitalizations or prevent the progression of congestive heart failure in patients with cardiovascular disease.
    Patent expiration dates:

    • November 5, 2019
      ✓ 
      Patent use: USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR FOR TREATING HYPERTENSION


    • May 5, 2020
      ✓ 
      Pediatric exclusivity




  • Eplerenone compositions having improved bioavailability
    Patent 6,495,165
    Issued: December 17, 2002
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G.D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,534,093
    Issued: March 18, 2003
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G.D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,558,707
    Issued: May 6, 2003
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE
      ✓ 
      Drug product


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor
    Patent 6,747,020
    Issued: June 8, 2004
    Inventor(s): Alfonzo T.; Perez & Debra J.; Asner & Richard J.; LaChapelle & John C.; Alexander & Barbara; Roniker
    Assignee(s): Pharmacia Corporation
    Methods of using eplerenone, an angiotensin converting enzyme inhibitor and optionally a diuretic are described for treatment of heart failure and hypertension.
    Patent expiration dates:

    • November 5, 2019
      ✓ 
      Patent use: USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND HYPERTENSION


    • May 5, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,863,902
    Issued: March 8, 2005
    Inventor(s): Thosar; Shilpa S. & Gokhale; Rajeev D. & Tolbert; Dwain S.
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • April 10, 2020
      ✓ 
      Patent use: TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
      ✓ 
      Drug product


    • October 10, 2020
      ✓ 
      Pediatric exclusivity




  • Micronized eplerenone compositions
    Patent 7,157,101
    Issued: January 2, 2007
    Inventor(s): Thosar; Shilpa S. & Gokhale; Rajeev D. & Tolbert; Dwain S.
    Assignee(s): G.D. Searle, LLC
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
      ✓ 
      Drug product


    • June 8, 2020
      ✓ 
      Pediatric exclusivity



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:
    • January 31, 2011 - INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC PATIENTS

    • July 31, 2011 - PEDIATRIC EXCLUSIVITY

See also...

  • Inspra Consumer Information (Wolters Kluwer)
  • Inspra Consumer Information (Cerner Multum)
  • Inspra Advanced Consumer Information (Micromedex)
  • Inspra AHFS DI Monographs (ASHP)
  • Eplerenone Consumer Information (Wolters Kluwer)
  • Eplerenone Consumer Information (Cerner Multum)
  • Eplerenone Advanced Consumer Information (Micromedex)
  • Eplerenone AHFS DI Monographs (ASHP)
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