Revatio is a drug owned by Viatris Specialty Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 31, 2030. Details of Revatio'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). | |||
|
US5250534 (Pediatric) | Pyrazolopyrimidinone antianginal agents |
Sep, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Revatio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Revatio, 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 Revatio.
Exclusivity Information
Revatio holds 8 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Revatio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-598) | May 07, 2012 |
| Pediatric Exclusivity(PED) | Mar 01, 2016 |
| New Dosage Form(NDF) | Aug 30, 2015 |
| M(M-61) | Aug 30, 2015 |
| New Dosing Schedule(D-137) | Jan 31, 2017 |
| M(M-133) | Jan 31, 2017 |
| M(M-287) | Jan 31, 2026 |
| Orphan Drug Exclusivity(ODE-469) | Jan 31, 2030 |
US patents provide insights into the exclusivity only within the United States, but Revatio 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 Revatio's family patents as well as insights into ongoing legal events on those patents.
Revatio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Revatio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 31, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Revatio Generic API suppliers:
Sildenafil Citrate is the generic name for the brand Revatio. 35 different companies have already filed for the generic of Revatio, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Revatio's generic
Alternative Brands for Revatio
There are several other brand drugs using the same active ingredient (Sildenafil Citrate) as Revatio. 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 Sildenafil Citrate, Revatio's active ingredient. Check the complete list of approved generic manufacturers for Revatio
About Revatio
Revatio is a drug owned by Viatris Specialty Llc. Revatio uses Sildenafil Citrate as an active ingredient. Revatio was launched by Viatris in 2005.
Approval Date:
Revatio was approved by FDA for market use on 03 June, 2005.
Active Ingredient:
Revatio uses Sildenafil Citrate as the active ingredient. Check out other Drugs and Companies using Sildenafil Citrate ingredient
Dosage:
Revatio is available in the following dosage forms - tablet form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |