Milestones in the Development of BiDil

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1986 The results of the first Vasodilator Heart Failure Trial (V-HeFT I) are published. The combination of hydralazine and isosorbide dinitrate (H/I) shows promise.

FIRST PATENT

1987 Jay Cohn of the University of Minnesota applies for a patent on the method of using hydralazine and isosorbide dinitrate together. BiDil is born.

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1991 A second trial, V-HeFT II, shows that enalapril, an ACE inhibitor, is more effective than H/I for treating heart failure.

1996 Cohn and Medco, which holds the patent rights to BiDil, bring the drug to the FDA for approval.

1997 The FDA rejects BiDil because the data from the V-HeFT trials do not meet the regulatory standards for approval.

1999 Cohn applies for a new patent specifying the use of H/I to treat heart failure in African-American patients.

SECOND PATENT

2000 The new race-specific patent for BiDil is approved.

2001 NitroMed, which now holds the rights to BiDil, begins testing the drug in the African-American Heart Failure Trial (A-HeFT).

2004 The A-HeFT results show that BiDil is effective in delaying hospitalization and death.

2005 The FDA approves BiDil as a treatment for African-Americans.

2007 FIRST PATENT EXPIRES

2020 SECOND PATENT EXPIRES

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