Starlix is a drug owned by Novartis Pharmaceuticals Corp. 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 Sep 15, 2020. Details of Starlix'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). | |||
| US6878749 | Method of treating metabolic disorders, especially diabetes, or a disease or condition associated with diabetes |
Sep, 2020
(4 years ago) |
Expired
|
| US6559188 | Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes |
Sep, 2020
(4 years ago) |
Expired
|
| US6844008 | Tablet composition |
Nov, 2017
(7 years ago) |
Expired
|
| US6641841 | Tablet composition |
Nov, 2017
(7 years ago) |
Expired
|
| US5488150 | Crystals of N-(trans-4-isopropylcyclohexycarbonyl)-D-phenylalanine and methods for preparing them |
Jan, 2013
(11 years ago) |
Expired
|
| US5463116 | Crystals of N- (trans-4-isopropylcyclohexlycarbonyl)-D-phenylalanine and methods for preparing them |
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 Starlix's patents.
Latest Legal Activities on Starlix's Patents
Given below is the list of recent legal activities going on the following patents of Starlix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 10 May, 2013 | US6878749 |
| Post Issue Communication - Certificate of Correction | 22 Jan, 2008 | US6844008 |
| Case Docketed to Examiner in GAU Critical | 17 Jul, 2007 | US6844008 |
| Post Issue Communication - Certificate of Correction | 10 Jan, 2007 | US6641841 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Apr, 2005 | US6878749 |
| Recordation of Patent Grant Mailed Critical | 12 Apr, 2005 | US6878749 |
| Issue Notification Mailed Critical | 23 Mar, 2005 | US6878749 |
| Application Is Considered Ready for Issue Critical | 15 Mar, 2005 | US6878749 |
| Dispatch to FDC | 15 Mar, 2005 | US6878749 |
| Receipt into Pubs | 15 Mar, 2005 | US6878749 |
US patents provide insights into the exclusivity only within the United States, but Starlix 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 Starlix's family patents as well as insights into ongoing legal events on those patents.
Starlix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Starlix's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 15, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Starlix Generic API suppliers:
Nateglinide is the generic name for the brand Starlix. 8 different companies have already filed for the generic of Starlix, with Alvogen having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Starlix's generic
How can I launch a generic of Starlix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Starlix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Starlix'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 Starlix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg and 120 mg | 22 Dec, 2004 |
About Starlix
Starlix is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing blood glucose levels in individuals with diabetes, particularly type 2 diabetes. Starlix uses Nateglinide as an active ingredient. Starlix was launched by Novartis in 2000.
Approval Date:
Starlix was approved by FDA for market use on 22 December, 2000.
Active Ingredient:
Starlix uses Nateglinide as the active ingredient. Check out other Drugs and Companies using Nateglinide ingredient
Treatment:
Starlix is used for managing blood glucose levels in individuals with diabetes, particularly type 2 diabetes.
Dosage:
Starlix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |