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Finasteride Patent History and Generic Timeline: Everything Clinicians and Patients Need to Know

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At a glance

  • Drug class / Type II 5-alpha reductase inhibitor [3]
  • Proscar 5 mg approval / 06/19/1992, NDA 020180 [2]
  • Propecia 1 mg approval / 12/19/1997, NDA 020788 [1]
  • Current application holder / Organon, both strengths [1][2]
  • Generic tablet strengths / 1 mg and 5 mg oral tablets [3]
  • Approved dosage form / oral tablet [3]
  • Prescription status / prescription only; 1 mg is for men only [3]
  • Boxed warning / none on either product [3][4]

What the approval records show

Finasteride has two new drug applications, one for each tablet strength.

Proscar, the 5 mg tablet, was approved on 06/19/1992 as NDA 020180. Drugs@FDA classifies that original approval as type 1, a new molecular entity, reviewed on priority [2]. Propecia, the 1 mg tablet, was approved on 12/19/1997 as NDA 020788, a type 3 approval for a new dosage form, under standard review [1]. Both applications now list Organon as the company [1][2].

Proscar's labeled use is symptomatic benign prostatic hyperplasia in men with an enlarged prostate: improving symptoms, reducing the risk of acute urinary retention, and reducing the need for surgery including transurethral resection of the prostate and prostatectomy [4]. The label also carries a limitation of use: Proscar is not approved for the prevention of prostate cancer [4].

Propecia's labeled use is male pattern hair loss (androgenetic alopecia) in men only. Efficacy in bitemporal recession has not been established, and it is not indicated for women [3]. Both products are prescription-only, and the 1 mg product is for men only [3].

When did generic finasteride appear?

Generic finasteride 1 mg and 5 mg tablets are FDA-approved under many abbreviated new drug applications, for example Dr. Reddy's in 2006, Aurobindo in 2007 and Accord in 2013 [3]. Patent numbers and expiry dates are not listed on this page.

How the label changed over the same period

The Propecia application's supplement history on Drugs@FDA includes labeling supplements dated 06/09/2011, 04/11/2012, 06/15/2021 and 08/01/2022 [1]. The current Propecia label is effective 10/14/2024 [3].

The 2022 change has the clearest paper trail. On 05/31/2022 the FDA sent a safety labeling change order under section 505(o)(4) of the FD&C Act citing new safety information on the risk of suicidal ideation and behavior, additional risk of sexual dysfunction, and psychoneurocognitive adverse events. Supplement S-030, approved 08/01/2022, changed the postmarketing wording to depression, suicidal ideation and behavior [5]. Proscar's most recent labeling supplement, S-050, was approved 03/18/2026 [2].

Neither product carries a boxed warning. Depression and suicidal ideation appear in the Postmarketing Experience section (6.2) rather than in a boxed warning or a numbered Warnings and Precautions subsection: the Propecia label lists depression, suicidal ideation and behavior [3], and the Proscar label lists depression and suicidal ideation [4].

Label warnings that apply to both products

Both strengths are listed as prescription brand products [1][2]. The labels say finasteride can be harmful to a male fetus, that women who are or may be pregnant must not take it or handle crushed or broken tablets, and that a confirmed rise in PSA while taking it should be evaluated [3][4]. The Propecia label is effective 10/14/2024 [3], and Proscar's current label reflects supplement S-050 [2].

Frequently asked questions

When was finasteride first approved in the United States?
Proscar 5 mg was approved on 06/19/1992 as NDA 020180, a type 1 new molecular entity approval with priority review, and Propecia 1 mg on 12/19/1997 as NDA 020788, a type 3 approval for a new dosage form. Both applications are now held by Organon [1][2].
Are generic finasteride tablets available?
Yes. Generic finasteride 1 mg and 5 mg tablets are FDA-approved under multiple abbreviated new drug applications [3]. Examples include Dr. Reddy's in 2006, Aurobindo in 2007 and Accord in 2013.
Is Proscar approved to prevent prostate cancer?
No. The label states a limitation of use: Proscar is not approved for the prevention of prostate cancer. In the 7-year Prostate Cancer Prevention Trial of 18,882 men, Gleason 8 to 10 cancer was found in 1.8% of men on finasteride 5 mg versus 1.1% on placebo [4].
Does finasteride carry a boxed warning for depression or sexual side effects?
No. Neither Propecia nor Proscar has a boxed warning. The Propecia label lists depression, suicidal ideation and behavior, and sexual dysfunction that continued after stopping treatment, in its Postmarketing Experience section, noting that these voluntary reports come from a population of uncertain size and a causal relationship cannot reliably be established [3][5]. The Proscar label lists depression and suicidal ideation in the same section [4].

References

  1. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  4. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration
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