Solaraze is a drug owned by Fougera Pharmaceuticals Inc. It is protected by 6 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 Aug 11, 2015. Details of Solaraze'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). | |||
| US5914322 | Treatment of disease and conditions |
Aug, 2015
(9 years ago) |
Expired
|
| US5985850 | Compositions comprising hyaluronic acid and drugs |
Aug, 2015
(9 years ago) |
Expired
|
| US5792753 | Compositions comprising hyaluronic acid and prostaglandin-synthesis-inhibiting drugs |
Aug, 2015
(9 years ago) |
Expired
|
| US5929048 | Treatment of conditions and disease |
Jun, 2014
(10 years ago) |
Expired
|
| US5639738 | Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs |
Jun, 2014
(10 years ago) |
Expired
|
| US5852002 | Treatment of conditions and disease |
Jun, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Solaraze 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 Solaraze's family patents as well as insights into ongoing legal events on those patents.
Solaraze's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Solaraze's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 11, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Solaraze Generic API suppliers:
Diclofenac Sodium is the generic name for the brand Solaraze. 41 different companies have already filed for the generic of Solaraze, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Solaraze's generic
How can I launch a generic of Solaraze before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Solaraze's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Solaraze'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 Solaraze -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.03 | 16 Dec, 2009 | 1 | 28 Oct, 2013 | 11 Aug, 2015 | Deferred |
Alternative Brands for Solaraze
Solaraze which is used for treating actinic keratoses., has several other brand drugs using the same active ingredient (Diclofenac Sodium). 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 | |
|---|---|---|
| Falcon Pharms |
| |
| Horizon |
| |
| Javelin Pharms Inc |
| |
| Nuvo Pharms Inc |
| |
| Pfizer |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Sodium, Solaraze's active ingredient. Check the complete list of approved generic manufacturers for Solaraze
About Solaraze
Solaraze is a drug owned by Fougera Pharmaceuticals Inc. It is used for treating actinic keratoses. Solaraze uses Diclofenac Sodium as an active ingredient. Solaraze was launched by Fougera Pharms in 2000.
Approval Date:
Solaraze was approved by FDA for market use on 16 October, 2000.
Active Ingredient:
Solaraze uses Diclofenac Sodium as the active ingredient. Check out other Drugs and Companies using Diclofenac Sodium ingredient
Treatment:
Solaraze is used for treating actinic keratoses.
Dosage:
Solaraze is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | TOPICAL |