Sprix is a drug owned by Zyla Life Sciences Us Inc. It is protected by 2 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 Dec 25, 2018. Details of Sprix'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). | |||
| US6333044 | Therapeutic compositions for intranasal administration which include KETOROLAC® |
Dec, 2018
(5 years ago) |
Expired
|
| US7476689 | Therapeutic compositions for intranasal administration which include KETOROLAC |
Oct, 2012
(12 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 Sprix's patents.
Latest Legal Activities on Sprix's Patents
Given below is the list of recent legal activities going on the following patents of Sprix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 10 Feb, 2017 | US7476689 |
| Correspondence Address Change Critical | 27 Oct, 2010 | US7476689 |
| Recordation of Patent Grant Mailed Critical | 13 Jan, 2009 | US7476689 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Jan, 2009 | US7476689 |
| Issue Notification Mailed Critical | 22 Dec, 2008 | US7476689 |
| Dispatch to FDC | 15 Dec, 2008 | US7476689 |
| Printer Rush- No mailing | 05 Dec, 2008 | US7476689 |
| Pubs Case Remand to TC Critical | 13 Nov, 2008 | US7476689 |
| Printer Rush- No mailing | 05 Nov, 2008 | US7476689 |
| Pubs Case Remand to TC Critical | 29 Sep, 2008 | US7476689 |
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 Sprix and ongoing litigations to help you estimate the early arrival of Sprix generic.
Sprix's Litigations
Sprix been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 13, 1997, against patent number US6333044. The petitioner , challenged the validity of this patent, with SANTUS et al as the respondent. Click below to track the latest information on how companies are challenging Sprix's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6333044 | June, 1997 |
Decision
(28 Aug, 2000) | SANTUS et al | |
FDA has granted some exclusivities to Sprix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sprix, 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 Sprix.
Exclusivity Information
Sprix holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Sprix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | May 14, 2013 |
US patents provide insights into the exclusivity only within the United States, but Sprix 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 Sprix's family patents as well as insights into ongoing legal events on those patents.
Sprix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sprix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 25, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sprix Generic API suppliers:
Ketorolac Tromethamine is the generic name for the brand Sprix. 35 different companies have already filed for the generic of Sprix, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sprix's generic
How can I launch a generic of Sprix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sprix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sprix'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 Sprix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15.75 mg/spray | 12 Mar, 2012 | 1 | 25 Dec, 2018 | Extinguished |
Alternative Brands for Sprix
Sprix which is used for treating inflammation, pain, and nasal-related conditions with a nasal spray of ketorolac tromethamine., has several other brand drugs using the same active ingredient (Ketorolac Tromethamine). 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 Ketorolac Tromethamine, Sprix's active ingredient. Check the complete list of approved generic manufacturers for Sprix
About Sprix
Sprix is a drug owned by Zyla Life Sciences Us Inc. It is used for treating inflammation, pain, and nasal-related conditions with a nasal spray of ketorolac tromethamine. Sprix uses Ketorolac Tromethamine as an active ingredient. Sprix was launched by Zyla in 2010.
Approval Date:
Sprix was approved by FDA for market use on 14 May, 2010.
Active Ingredient:
Sprix uses Ketorolac Tromethamine as the active ingredient. Check out other Drugs and Companies using Ketorolac Tromethamine ingredient
Treatment:
Sprix is used for treating inflammation, pain, and nasal-related conditions with a nasal spray of ketorolac tromethamine.
Dosage:
Sprix is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15.75MG/SPRAY | SPRAY, METERED | Prescription | NASAL |