Viagra is a drug owned by Viatris Specialty Llc. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 22, 2020. Details of Viagra'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). | |||
|
US6469012 (Pediatric) | Pyrazolopyrimidinones for the treatment of impotence |
Apr, 2020
(4 years ago) |
Expired
|
| US6469012 | Pyrazolopyrimidinones for the treatment of impotence |
Oct, 2019
(5 years ago) |
Expired
|
|
US5250534 (Pediatric) | Pyrazolopyrimidinone antianginal agents |
Sep, 2012
(12 years ago) |
Expired
|
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 Viagra and ongoing litigations to help you estimate the early arrival of Viagra generic.
Viagra's Litigations
Viagra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 23, 2000, against patent number US6469012. The petitioner , challenged the validity of this patent, with ELLIS et al as the respondent. Click below to track the latest information on how companies are challenging Viagra's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6469012 | May, 2000 |
Decision
(29 Nov, 2000) | ELLIS et al | |
US patents provide insights into the exclusivity only within the United States, but Viagra 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 Viagra's family patents as well as insights into ongoing legal events on those patents.
Viagra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Viagra's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 22, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Viagra Generic API suppliers:
Sildenafil Citrate is the generic name for the brand Viagra. 35 different companies have already filed for the generic of Viagra, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Viagra's generic
How can I launch a generic of Viagra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Viagra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Viagra'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 Viagra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg and 50 mg | 19 Nov, 2004 | 1 | 09 Mar, 2016 | 22 Oct, 2019 | Eligible |
| 100 mg | 25 Oct, 2004 | 1 | 09 Mar, 2016 | 22 Oct, 2019 | Eligible |
Alternative Brands for Viagra
Viagra which is used for treating erectile dysfunction., has several other brand drugs in the same treatment category and using the same active ingredient (Sildenafil Citrate). 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 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. Sildenafil Citrate. 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 Sildenafil Citrate, Viagra's active ingredient. Check the complete list of approved generic manufacturers for Viagra
About Viagra
Viagra is a drug owned by Viatris Specialty Llc. It is used for treating erectile dysfunction. Viagra uses Sildenafil Citrate as an active ingredient. Viagra was launched by Viatris in 1998.
Approval Date:
Viagra was approved by FDA for market use on 27 March, 1998.
Active Ingredient:
Viagra uses Sildenafil Citrate as the active ingredient. Check out other Drugs and Companies using Sildenafil Citrate ingredient
Treatment:
Viagra is used for treating erectile dysfunction.
Dosage:
Viagra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET | Prescription | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |