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Cialis (Tadalafil) Manufacturing, Supply, and Shortage History

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At a glance

  • Brand product / Cialis (tadalafil) tablets, Eli Lilly, NDA 021368 [1]
  • First US approval / 21 November 2003, new molecular entity [1]
  • Prescription strengths / 5, 10 and 20 mg tablets [1]
  • 2.5 mg tablet / Listed as discontinued in Drugs@FDA [1]
  • PAH product / Adcirca 20 mg, separate NDA 022332, approved 22 May 2009 [2]
  • 20 mg generics rated to Adcirca / More than ten ANDAs, all rated AB2 and all prescription [2]
  • Current Cialis label / Effective 3 June 2026 [3]

Who holds the Cialis application?

Drugs@FDA lists Lilly as the company on Cialis, filed as new drug application 021368. The original approval was on 21 November 2003 as a type 1 new molecular entity, and the 5, 10 and 20 mg tablets are listed as Prescription [1]. The 2.5 mg tablet has a discontinued marketing status, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons [1].

The current Cialis label is effective 3 June 2026. It covers erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and both conditions together. When Cialis is used with finasteride to start BPH treatment, the label recommends use for up to 26 weeks. The label also says not to split the tablets; the entire dose is taken [3].

How many generic tadalafil products are approved?

Generic tadalafil tablets are approved under many separate FDA applications. Drugs@FDA's equivalence table for Adcirca alone lists more than ten tadalafil 20 mg ANDAs from separate companies, each rated AB2 to Adcirca and each marked Prescription: Teva (sold as Alyq), Ajanta, Aurobindo, Chartwell, Cipla, Dr Reddy's, Hetero, Jubilant, Macleods, Prinston, Sunshine and Torrent [2].

The approval record therefore shows one brand application for Cialis, a separate application for Adcirca, and a crowded generic market, all prescription-only [1][2].

Why Cialis and Adcirca are separate products

Adcirca is a tadalafil 20 mg tablet approved on 22 May 2009 under its own application, NDA 022332 [2]. The PHIRST trial studied tadalafil in patients with pulmonary arterial hypertension. In that 16-week study of 405 patients, only the 40 mg once-daily dose met the prespecified significance level, and the mean placebo-corrected change in six-minute walk distance was 33 m (95% CI 15 to 50 m) [4]. That 40 mg daily dose is above the 20 mg top as-needed dose of Cialis for ED [3][4].

Both products are tadalafil, and the Cialis label states that combining it with other PDE5 inhibitors or other ED treatments has not been studied [3].

Frequently asked questions

Who holds the FDA application for Cialis?
Eli Lilly. Drugs@FDA lists Cialis under NDA 021368 with an original approval date of 21 November 2003 [1].
Is the 2.5 mg Cialis tablet still on the market?
Drugs@FDA lists the 2.5 mg tablet as discontinued, noting a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons. The 5, 10 and 20 mg tablets are listed as prescription [1].
How many companies have approved generic tadalafil 20 mg tablets?
Drugs@FDA's equivalence table for Adcirca lists more than ten tadalafil 20 mg ANDAs from separate companies, each rated AB2 to Adcirca [2].
Can tadalafil be bought without a prescription?
Drugs@FDA lists Cialis 5, 10 and 20 mg tablets and Adcirca 20 mg tablets with a Prescription marketing status, and the generic 20 mg tablets on the Adcirca equivalence table are also listed as Prescription [1][2].
What is the difference between Cialis and Adcirca?
They are separate applications. Cialis, NDA 021368 approved in 2003, is for erectile dysfunction and BPH [3]; Adcirca, NDA 022332, is a tadalafil 20 mg tablet product approved 22 May 2009 [2]. The PHIRST trial studied tadalafil in pulmonary arterial hypertension, and the 40 mg once-daily dose met the prespecified significance level [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. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  4. Galiè N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119(22):2894-903. Tadalafil therapy for pulmonary arterial hypertension
Evidence overview for Cialis (Tadalafil) Manufacturing, Supply, and Shortage History