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Tadalafil (Generic) Regulatory Status: US, EU, Canada, and UK

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At a glance

  • US brand approval / Cialis, NDA 021368, 21 November 2003 [4]
  • US marketing status / Prescription [4]
  • US approved indications / Erectile dysfunction, BPH, and ED with BPH [1]
  • Cialis strengths in Drugs@FDA / 5, 10 and 20 mg prescription; 2.5 mg discontinued [4]
  • US generics / Multiple approved ANDAs, including products rated equivalent to Adcirca for PAH [3]
  • PAH product / Adcirca 20 mg tablets, approved 22 May 2009 [2][3]
  • Sport status / Not named on the WADA 2026 or 2027 Prohibited List [5][6]

What the US approval record shows

Cialis (tadalafil tablets) is NDA 021368, held by Lilly, first approved on 21 November 2003 as a new molecular entity [4]. The current label (effective 3 June 2026) lists three indications: erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia (BPH), and the two together [1]. If Cialis is used with finasteride to start BPH treatment, the label recommends use for up to 26 weeks [1].

Drugs@FDA lists the 5, 10 and 20 mg Cialis tablets as prescription products and the 2.5 mg tablet as discontinued, with a Federal Register note that the product was not discontinued or withdrawn for safety or effectiveness reasons [4].

Generics: what the FDA record lists

Generic tadalafil tablets are approved under many abbreviated new drug applications. FDA records list generic tadalafil 20 mg tablets rated as therapeutically equivalent to Adcirca for PAH, including products from Cipla, Hetero and Chartwell [3]. Alyq (Teva), one of the 20 mg tablets listed as equivalent to Adcirca, follows the Adcirca labeling and PAH dose rather than the Cialis dose [3][7].

All 138 tadalafil drug labels in openFDA are prescription labels, and no over-the-counter tadalafil product was found. HealthRX.com offers tadalafil by prescription.

The PAH products are a separate approval

Adcirca (tadalafil 20 mg tablets) is NDA 022332, first approved on 22 May 2009 for pulmonary arterial hypertension (WHO Group 1) to improve exercise ability, with a label effective 15 December 2025 [2][3]. Adcirca and Cialis are separate tadalafil products that both have 20 mg tablets; the labeled Adcirca dose for PAH is 40 mg once daily, taken as two 20 mg tablets [2][3]. The Adcirca label says patients should not take other PDE5 inhibitors, including Cialis [2].

Other tadalafil PAH products include Alyq tablets and Tadliq oral suspension. Opsynvi combines macitentan with tadalafil and carries a boxed warning for embryo-fetal toxicity from macitentan [7][8][9].

EU, Canada and the UK

This page covers US drug-approval records. Approval dates, prescription categories and generic-entry dates for the EU, Canada and the UK are not established here.

Sport

Tadalafil is not named in the WADA 2026 Prohibited List or in the 2027 List, which takes effect on 1 January 2027 [5][6].

Frequently asked questions

Is generic tadalafil FDA approved?
Yes. Generic tadalafil tablets are approved under many abbreviated new drug applications, and FDA records list generic 20 mg tablets rated as equivalent to Adcirca for PAH, including products from Cipla, Hetero and Chartwell [3].
Do I need a prescription for tadalafil in the US?
Yes. Drugs@FDA lists Cialis and the generic tadalafil 20 mg tablets rated equivalent to Adcirca as prescription products [3][4]. No over-the-counter tadalafil product was found in openFDA labels.
Is tadalafil approved in the EU, Canada and the UK?
Approval dates and prescription categories for the EU, Canada and the UK are not established here; this page covers US records.
Which Cialis strengths are current in the US?
Drugs@FDA lists the 5, 10 and 20 mg tablets as prescription and the 2.5 mg tablet as discontinued, with a Federal Register note that it was not withdrawn for safety or effectiveness reasons [4].
What is Adcirca approved for?
Adcirca, tadalafil 20 mg tablets, was approved on 22 May 2009 for pulmonary arterial hypertension to improve exercise ability. The labeled dose is 40 mg once daily, taken as two 20 mg tablets [2][3].
Is tadalafil on the WADA prohibited list?
It is not named in the WADA 2026 Prohibited List or the 2027 List that takes effect on 1 January 2027 [5][6].

References

  1. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  2. U.S. National Library of Medicine, DailyMed. Adcirca (tadalafil) tablets, Lilly prescribing information. Adcirca (tadalafil) tablets, Lilly label
  3. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  4. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  5. World Anti-Doping Agency. World Anti-Doping Agency
  6. World Anti-Doping Agency. World Anti-Doping Agency
  7. U.S. National Library of Medicine, DailyMed. Alyq (tadalafil) tablets, Teva prescribing information. Alyq (tadalafil) tablets, Teva label
  8. U.S. National Library of Medicine, DailyMed. Tadliq (tadalafil) oral suspension prescribing information. Tadliq (tadalafil) oral suspension label
  9. U.S. National Library of Medicine, DailyMed. Opsynvi (macitentan and tadalafil) tablets, Actelion prescribing information. Opsynvi (macitentan and tadalafil) tablets, Actelion label
Evidence overview for tadalafil generic: Tadalafil (Generic) Regulatory Status: US, EU, Canada, and UK