Nateglinide Patent Expiration

Nateglinide is Used for managing blood glucose levels in individuals with diabetes, particularly type 2 diabetes. It was first introduced by Novartis Pharmaceuticals Corp in its drug Starlix on Dec 22, 2000. 9 different companies have introduced drugs containing Nateglinide.


Nateglinide Patents

Given below is the list of patents protecting Nateglinide, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Starlix US6559188 Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes Sep 15, 2020

(Expired)

Novartis
Starlix US6878749 Method of treating metabolic disorders, especially diabetes, or a disease or condition associated with diabetes Sep 15, 2020

(Expired)

Novartis
Starlix US6641841 Tablet composition Nov 14, 2017

(Expired)

Novartis
Starlix US6844008 Tablet composition Nov 14, 2017

(Expired)

Novartis
Starlix US5488150 Crystals of N-(trans-4-isopropylcyclohexycarbonyl)-D-phenylalanine and methods for preparing them Jan 30, 2013

(Expired)

Novartis
Starlix US5463116 Crystals of N- (trans-4-isopropylcyclohexlycarbonyl)-D-phenylalanine and methods for preparing them Oct 21, 2012

(Expired)

Novartis



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 Nateglinide's patents.

Given below is the list recent legal activities going on the following patents of Nateglinide.

Activity Date Patent Number
Patent litigations
Expire Patent 10 May, 2013 US6878749
Post Issue Communication - Certificate of Correction 22 Jan, 2008 US6844008
Case Docketed to Examiner in GAU 17 Jul, 2007 US6844008
Post Issue Communication - Certificate of Correction 10 Jan, 2007 US6641841
Patent Issue Date Used in PTA Calculation 12 Apr, 2005 US6878749
Recordation of Patent Grant Mailed 12 Apr, 2005 US6878749
Issue Notification Mailed 23 Mar, 2005 US6878749
Application Is Considered Ready for Issue 15 Mar, 2005 US6878749
Dispatch to FDC 15 Mar, 2005 US6878749
Receipt into Pubs 15 Mar, 2005 US6878749


Nateglinide's Family Patents

Family Patents

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Nateglinide Generic API Manufacturers

Several generic applications have been filed for Nateglinide. The first generic version for Nateglinide was by Dr Reddys Laboratories Ltd and was approved on Sep 9, 2009. And the latest generic version is by Cadila Pharmaceuticals Ltd and was approved on Apr 19, 2019.

Given below is the list of companies who have filed for Nateglinide generic, along with the locations of their manufacturing plants worldwide.


1. ALVOGEN

Alvogen Inc has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG

tablet Discontinued ORAL N/A Dec 11, 2015
120MG

tablet Discontinued ORAL N/A Dec 11, 2015


Manufacturing Plant Locations
New

Alvogen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Alvogen as present at those locations.

Country City Firm Name
United States
Morristown Alvogen, Inc





2. CADILA PHARMS LTD

Cadila Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Cadila Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG

tablet Prescription ORAL AB Apr 19, 2019
120MG

tablet Prescription ORAL AB Apr 19, 2019





3. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

tablet Prescription ORAL AB Sep 9, 2009
60MG

tablet Prescription ORAL AB Sep 9, 2009





4. RISING

Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG

tablet Prescription ORAL AB Jun 18, 2018
120MG

tablet Prescription ORAL AB Jun 18, 2018


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





5. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG

tablet Prescription ORAL AB Sep 9, 2009
120MG

tablet Prescription ORAL AB Sep 9, 2009


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





6. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

tablet Discontinued ORAL N/A Sep 9, 2009
60MG

tablet Discontinued ORAL N/A Sep 9, 2009





7. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
120MG

tablet Prescription ORAL AB Mar 30, 2011
60MG

tablet Prescription ORAL AB Mar 30, 2011





8. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Nateglinide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
60MG

tablet Prescription ORAL AB Jul 6, 2016
120MG

(reference standard)

tablet Prescription ORAL AB Jul 6, 2016