Cialis is a drug owned by Eli Lilly And Co. It is protected by 9 US drug patents filed from 2013 to 2018 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2021. Details of Cialis's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6821975 (Pediatric) | Beta-carboline drug products |
May, 2021
(3 years ago) |
Expired
|
| US6821975 | Beta-carboline drug products |
Nov, 2020
(4 years ago) |
Expired
|
|
US6943166 (Pediatric) | Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction |
Oct, 2020
(4 years ago) |
Expired
|
|
US7182958 (Pediatric) | β-carboline pharmaceutical compositions |
Oct, 2020
(4 years ago) |
Expired
|
| US6943166 | Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction |
Apr, 2020
(4 years ago) |
Expired
|
| US7182958 | β-carboline pharmaceutical compositions |
Apr, 2020
(4 years ago) |
Expired
|
|
US5859006 (Pediatric) | Tetracyclic derivatives; process of preparation and use |
May, 2018
(6 years ago) |
Expired
|
| US5859006 | Tetracyclic derivatives; process of preparation and use |
Nov, 2017
(7 years ago) |
Expired
|
| US6140329 | Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence |
Jul, 2016
(8 years ago) |
Expired
|
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 Cialis's patents.
Latest Legal Activities on Cialis's Patents
Given below is the list of recent legal activities going on the following patents of Cialis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Review Certificate Mailed | 27 Jun, 2019 | US6821975 (Litigated) |
| Review Certificate Mailed | 26 Jun, 2019 | US7182958 (Litigated) |
| Review Certificate | 12 Jun, 2019 | US6821975 (Litigated) |
| Review Certificate | 12 Jun, 2019 | US7182958 (Litigated) |
| Request for Trial Denied Critical | 07 Dec, 2018 | US6943166 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jul, 2018 | US7182958 (Litigated) |
| Petition Requesting Trial | 07 Jun, 2018 | US6943166 (Litigated) |
| Termination or Final Written Decision | 27 Oct, 2017 | US6943166 (Litigated) |
| Termination or Final Written Decision | 03 Oct, 2017 | US6943166 (Litigated) |
| Termination or Final Written Decision | 16 Aug, 2017 | US6943166 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Cialis and ongoing litigations to help you estimate the early arrival of Cialis generic.
Cialis's Litigations
Cialis been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 13, 2015, against patent number US7182958. The petitioner Actelion Pharmaceuticals Ltd, challenged the validity of this patent, with ICOS Corporation as the respondent. Click below to track the latest information on how companies are challenging Cialis's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6943166 | June, 2018 |
Terminated-Denied
(07 Dec, 2018) | ICOS Corporation | Aquestive Therapeutics, Inc. |
| US6943166 | July, 2017 |
Terminated-Settled
(27 Oct, 2017) | ICOS Corporation | Dr. Reddy's Laboratories, Inc. |
| US6943166 | July, 2017 |
Terminated-Settled
(03 Oct, 2017) | ICOS Corporation | Argentum Pharmaceuticals LLC |
| US6943166 | November, 2016 |
Terminated-Settled
(16 Aug, 2017) | ICOS Corporation | Mylan Pharmaceuticals Inc. |
| US6943166 | December, 2016 |
Terminated-Denied
(03 Jul, 2017) | ICOS Corporation | MonoSol Rx, LLC |
| US6943166 | February, 2016 |
Terminated-Denied
(01 Sep, 2016) | ICOS Corporation | IntelGenx Corp. |
| US6821975 | January, 2015 |
FWD Entered
(03 Aug, 2016) | ICOS Corporation | Actelion Pharmaceuticals Ltd |
| US7182958 | January, 2015 |
FWD Entered
(03 Aug, 2016) | ICOS Corporation | Actelion Pharmaceuticals Ltd |
FDA has granted some exclusivities to Cialis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cialis, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cialis.
Exclusivity Information
Cialis holds 4 exclusivities. All of its exclusivities have expired in 2021. Details of Cialis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-641) | Oct 06, 2014 |
| New Indication(I-642) | Oct 06, 2014 |
| M(M-219) | Feb 15, 2021 |
| Pediatric Exclusivity(PED) | Aug 15, 2021 |
US patents provide insights into the exclusivity only within the United States, but Cialis is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cialis's family patents as well as insights into ongoing legal events on those patents.
Cialis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cialis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 15, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cialis Generic API suppliers:
Tadalafil is the generic name for the brand Cialis. 29 different companies have already filed for the generic of Cialis, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cialis's generic
How can I launch a generic of Cialis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cialis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cialis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Cialis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg | 14 Oct, 2008 | 1 | 22 May, 2018 | 19 Nov, 2020 | Eligible |
| 5 mg, 10 mg and 20 mg | 21 Nov, 2007 | 1 | 22 May, 2018 | 19 Nov, 2020 | Eligible |
Alternative Brands for Cialis
Cialis which is used for treating erectile dysfunction and sexual dysfunction., has several other brand drugs in the same treatment category and using the same active ingredient (Tadalafil). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Bayer Hlthcare |
| |||||
| Metuchen Pharms |
| |||||
| Mylan Speciality Lp |
| |||||
| Viatris |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tadalafil. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tadalafil, Cialis's active ingredient. Check the complete list of approved generic manufacturers for Cialis
About Cialis
Cialis is a drug owned by Eli Lilly And Co. It is used for treating erectile dysfunction and sexual dysfunction. Cialis uses Tadalafil as an active ingredient. Cialis was launched by Lilly in 2003.
Approval Date:
Cialis was approved by FDA for market use on 21 November, 2003.
Active Ingredient:
Cialis uses Tadalafil as the active ingredient. Check out other Drugs and Companies using Tadalafil ingredient
Treatment:
Cialis is used for treating erectile dysfunction and sexual dysfunction.
Dosage:
Cialis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG | TABLET | Discontinued | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |