Adcirca is a drug owned by Eli Lilly Co. It is protected by 6 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 May 19, 2021. Details of Adcirca'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
|
|
US7182958 (Pediatric) | β-carboline pharmaceutical compositions |
Oct, 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
|
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 Adcirca's patents.
Latest Legal Activities on Adcirca's Patents
Given below is the list of recent legal activities going on the following patents of Adcirca.
| 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) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jul, 2018 | US7182958 (Litigated) |
| Termination or Final Written Decision | 03 Aug, 2016 | US6821975 (Litigated) |
| Termination or Final Written Decision | 03 Aug, 2016 | US7182958 (Litigated) |
| Request for Trial Granted Critical | 04 Aug, 2015 | US7182958 (Litigated) |
| Petition Requesting Trial | 13 Jan, 2015 | US6821975 (Litigated) |
| Petition Requesting Trial | 13 Jan, 2015 | US7182958 (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 Adcirca and ongoing litigations to help you estimate the early arrival of Adcirca generic.
Adcirca's Litigations
Adcirca 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 Adcirca's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 Adcirca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Adcirca, 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 Adcirca.
Exclusivity Information
Adcirca holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Adcirca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 22, 2012 |
| Orphan Drug Exclusivity(ODE) | May 22, 2016 |
US patents provide insights into the exclusivity only within the United States, but Adcirca 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 Adcirca's family patents as well as insights into ongoing legal events on those patents.
Adcirca's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Adcirca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adcirca Generic API suppliers:
Tadalafil is the generic name for the brand Adcirca. 29 different companies have already filed for the generic of Adcirca, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Adcirca's generic
How can I launch a generic of Adcirca before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adcirca's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adcirca'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 Adcirca -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg | 15 Oct, 2009 | 1 | 03 Aug, 2018 | 26 Apr, 2020 | Eligible |
Alternative Brands for Adcirca
Adcirca which is used for treating pulmonary hypertension., has several other brand drugs 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tadalafil, Adcirca's active ingredient. Check the complete list of approved generic manufacturers for Adcirca
About Adcirca
Adcirca is a drug owned by Eli Lilly Co. It is used for treating pulmonary hypertension. Adcirca uses Tadalafil as an active ingredient. Adcirca was launched by Eli Lilly Co in 2009.
Approval Date:
Adcirca was approved by FDA for market use on 22 May, 2009.
Active Ingredient:
Adcirca uses Tadalafil as the active ingredient. Check out other Drugs and Companies using Tadalafil ingredient
Treatment:
Adcirca is used for treating pulmonary hypertension.
Dosage:
Adcirca is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |