Tadalafil Patent Expiration

Tadalafil is used for improving exercise ability in patients with Pulmonary Arterial Hypertension (PAH). It was first introduced by Eli Lilly And Co in its drug Cialis on Nov 21, 2003. Other drugs containing Tadalafil are Adcirca, Tadliq, Chewtadzy. 32 different companies have introduced drugs containing Tadalafil.


Tadalafil Patents

Given below is the list of patents protecting Tadalafil, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Adcirca US5859006 Tetracyclic derivatives; process of preparation and use Nov 21, 2017

(Expired)

Eli Lilly Co
Adcirca US5859006

(Pediatric)

Tetracyclic derivatives; process of preparation and use May 21, 2018

(Expired)

Eli Lilly Co
Adcirca US6821975 Beta-carboline drug products Nov 19, 2020

(Expired)

Eli Lilly Co
Adcirca US6821975

(Pediatric)

Beta-carboline drug products May 19, 2021

(Expired)

Eli Lilly Co
Adcirca US7182958 β-carboline pharmaceutical compositions Apr 26, 2020

(Expired)

Eli Lilly Co
Adcirca US7182958

(Pediatric)

β-carboline pharmaceutical compositions Oct 26, 2020

(Expired)

Eli Lilly Co
Cialis US5859006 Tetracyclic derivatives; process of preparation and use Nov 21, 2017

(Expired)

Lilly
Cialis US5859006

(Pediatric)

Tetracyclic derivatives; process of preparation and use May 21, 2018

(Expired)

Lilly
Cialis US6140329 Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence Jul 11, 2016

(Expired)

Lilly
Cialis US6821975 Beta-carboline drug products Nov 19, 2020

(Expired)

Lilly
Cialis US6821975

(Pediatric)

Beta-carboline drug products May 19, 2021

(Expired)

Lilly
Cialis US6943166 Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Apr 26, 2020

(Expired)

Lilly
Cialis US6943166

(Pediatric)

Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction Oct 26, 2020

(Expired)

Lilly
Cialis US7182958 β-carboline pharmaceutical compositions Apr 26, 2020

(Expired)

Lilly
Cialis US7182958

(Pediatric)

β-carboline pharmaceutical compositions Oct 26, 2020

(Expired)

Lilly
Tadliq US11382917 Liquid oral formulations for tadalafil Dec 24, 2038 Cmp Dev Llc
Tadliq US11666576 Liquid oral formulations for tadalafil Dec 24, 2038 Cmp Dev Llc
Tadliq US11975006 Liquid oral formulations for tadalafil Dec 24, 2038 Cmp Dev Llc


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tadalafil's patents.

Given below is the list recent legal activities going on the following patents of Tadalafil.

Event Date Patent/Publication
Patent litigations
Email Notification 06 Jun, 2023 US11666576
Mail Patent eGrant Notification 06 Jun, 2023 US11666576
Patent Issue Date Used in PTA Calculation 06 Jun, 2023 US11666576
Recordation of Patent Grant Mailed 06 Jun, 2023 US11666576
Electronic Review 06 Jun, 2023 US11666576
Recordation of Patent eGrant 06 Jun, 2023 US11666576
Patent eGrant Notification 06 Jun, 2023 US11666576
Email Notification 18 May, 2023 US11666576
Electronic Review 18 May, 2023 US11666576
Issue Notification Mailed 17 May, 2023 US11666576



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Tadalafil Generics

Several generic applications have been filed for Tadalafil. The first generic version for Tadalafil was by Teva Pharmaceuticals Usa and was approved on May 22, 2018. And the latest generic version is by Shandong New Time Pharmaceutical Co Ltd and was approved on Mar 4, 2024.

Given below is the list of companies who have filed for Tadalafil generic.


1. SHANDONG

Shandong New Time Pharmaceutical Co Ltd has filed for 1 generic for Tadalafil. Given below are the details of the strengths of this generic introduced by Shandong.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 4, 2024


2. HANGZHOU BINJIANG

Hangzhou Minsheng Binjiang Pharmaceutical Co Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Hangzhou Binjiang.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB1 Oct 27, 2020
2.5MG tablet Prescription ORAL AB1 Oct 27, 2020
20MG tablet Prescription ORAL AB1 Oct 27, 2020
10MG tablet Prescription ORAL AB1 Oct 27, 2020


3. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019


4. UNICHEM

Unichem Laboratories Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019


5. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB2 Nov 23, 2020
10MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019


6. WATSON LABS INC

Watson Laboratories Inc has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB1 Mar 29, 2019
2.5MG tablet Prescription ORAL AB1 Mar 29, 2019
10MG tablet Prescription ORAL AB1 Mar 29, 2019
20MG tablet Prescription ORAL AB1 Mar 29, 2019


7. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019


8. TORRENT

Torrent Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB2 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019


9. CIPLA

Cipla Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019


10. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Tadalafil. Out of these 20mg version comes by the name ALYQ. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB1 May 22, 2018
2.5MG tablet Prescription ORAL AB1 May 22, 2018
20MG tablet Prescription ORAL AB2 Feb 5, 2019
5MG tablet Prescription ORAL AB1 May 22, 2018


11. QILU PHARM HAINAN

Qilu Pharmaceutical Hainan Co Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Qilu Pharm Hainan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019


12. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019


13. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Discontinued ORAL N/A Jun 6, 2023


14. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019


15. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Oct 23, 2019


16. UMEDICA

Umedica Laboratories Private Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Umedica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL BX Oct 23, 2020
5MG tablet Prescription ORAL BX Oct 23, 2020
10MG tablet Prescription ORAL BX Oct 23, 2020
20MG tablet Prescription ORAL BX Oct 23, 2020


17. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Discontinued ORAL N/A Dec 29, 2020
2.5MG tablet Discontinued ORAL N/A Dec 29, 2020
5MG tablet Discontinued ORAL N/A Dec 29, 2020
10MG tablet Discontinued ORAL N/A Dec 29, 2020


18. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019


19. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB2 Aug 11, 2022
10MG tablet Prescription ORAL AB1 Aug 11, 2022
5MG tablet Prescription ORAL AB1 Aug 11, 2022
2.5MG tablet Prescription ORAL AB1 Aug 11, 2022


20. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB2 Oct 16, 2019
10MG tablet Prescription ORAL AB1 Oct 7, 2019
5MG tablet Prescription ORAL AB1 Oct 7, 2019
2.5MG tablet Prescription ORAL AB1 Oct 7, 2019


21. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 3 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB1 Mar 3, 2023
10MG tablet Prescription ORAL AB1 Mar 3, 2023
20MG tablet Prescription ORAL AB1 Mar 3, 2023


22. TEVA PHARMS INC

Teva Pharmaceuticals Inc has filed for 1 generic for Tadalafil. This 20mg version comes by the name ALYQ. Given below are the details of the strengths of this generic introduced by Teva Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB2 Oct 12, 2022


23. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Discontinued ORAL N/A Aug 3, 2018
5MG tablet Discontinued ORAL N/A Apr 29, 2019


24. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019


25. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Discontinued ORAL N/A Apr 29, 2019
2.5MG tablet Discontinued ORAL N/A Apr 29, 2019
10MG tablet Discontinued ORAL N/A Apr 29, 2019


26. VKT PHARMA

Vkt Pharma Private Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Vkt Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Nov 4, 2021
2.5MG tablet Prescription ORAL AB1 Nov 4, 2021
5MG tablet Prescription ORAL AB1 Nov 4, 2021
10MG tablet Prescription ORAL AB1 Nov 4, 2021


27. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet Prescription ORAL AB1 Mar 26, 2019
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019


28. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Tadalafil. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG tablet Prescription ORAL AB1 Mar 26, 2019
5MG tablet Prescription ORAL AB1 Mar 26, 2019
10MG tablet Prescription ORAL AB1 Mar 26, 2019
20MG tablet Prescription ORAL AB1 Mar 26, 2019