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Cialis Patent History and Generic Tadalafil Timeline

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At a glance

  • Cialis NDA 021368 original approval / 11/21/2003 [2]
  • Adcirca NDA 022332 original approval / 05/22/2009 [3]
  • Original ANDA approval date for Cipla, Hetero and Chartwell tadalafil / 02/05/2019 [2]
  • Cialis strengths listed as prescription / 5, 10 and 20 mg [2]
  • Cialis 2.5 mg tablet status / Discontinued [2]
  • Tadalafil 20 mg products listed as Adcirca equivalents / Alyq and multiple ANDA holders [3]
  • Orange Book patent table, Cialis 10 mg / No patent numbers or expiration dates listed [1]
  • Cialis indications / ED, BPH and ED with BPH [4]

What the approval records show

Cialis is tadalafil tablets in 5, 10 and 20 mg strengths under NDA 021368, held by Lilly [2]. Drugs@FDA dates the original approval to 11/21/2003 and classifies it as a new molecular entity [2]. The listing shows the 5, 10 and 20 mg tablets as prescription and the 2.5 mg tablet as discontinued [2]. The label covers erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and ED with BPH [4].

Adcirca is a separate product: tadalafil 20 mg tablets under NDA 022332, with an original approval date of 05/22/2009, listed as a prescription product [3]. Both Cialis and Adcirca are tadalafil [2][3].

What the Orange Book patent page shows

The Orange Book page for the Cialis 10 mg product, product 002 of NDA 021368, shows an empty patent table, with no patent numbers and no expiration dates, and an empty exclusivity table [1]. The FDA records on this page document approval dates but do not establish a patent-by-patent timeline for Cialis.

Generic tadalafil in the approval records

Drugs@FDA dates the original ANDA approvals for the Cipla, Hetero and Chartwell tadalafil products to 02/05/2019 [2]. The FDA therapeutic equivalence listing for Adcirca also includes a group of tadalafil 20 mg tablet products, among them Alyq from Teva and applications held by Aurobindo, Chartwell, Cipla, Dr Reddy's, Hetero, Jubilant, Macleods, Prinston, Sunshine and Torrent [3]. Each appears in that listing as a prescription product [3].

Frequently asked questions

When was Cialis first approved?
Cialis, NDA 021368, received original FDA approval on 11/21/2003 as a new molecular entity [2].
When was Adcirca approved?
Adcirca, NDA 022332, is a separate tadalafil 20 mg tablet product with an original approval date of 05/22/2009 [3].
Which Cialis strengths does the FDA list?
The listing shows 5, 10 and 20 mg tablets as prescription and the 2.5 mg tablet as discontinued [2].
Are generic tadalafil tablets approved by the FDA?
Yes. Drugs@FDA dates the original ANDA approvals for Cipla, Hetero and Chartwell tadalafil products to 02/05/2019 [2], and the therapeutic equivalence listing for Adcirca includes tadalafil 20 mg tablets from Alyq (Teva) and from Aurobindo, Chartwell, Cipla, Dr Reddy's, Hetero, Jubilant, Macleods, Prinston, Sunshine and Torrent [3].
Does the Orange Book list a patent for Cialis?
The Orange Book page for the Cialis 10 mg product shows no patent numbers, no patent expiration dates and no exclusivity entries [1].
What is Cialis approved to treat?
Erectile dysfunction, benign prostatic hyperplasia, and ED with BPH. The 5 mg once-daily dose is the one used for BPH and for ED with BPH [4].

References

  1. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
  2. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  3. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  4. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
Evidence overview for Cialis Patent History and Generic Tadalafil Timeline