Generic Inspra Availability

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
  • 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

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
Hide
(web4)