Metformin Hydrochloride; Saxagliptin Hydrochloride Patent Expiration

Metformin Hydrochloride; Saxagliptin Hydrochloride is Used for improving glycemic control in adults with type 2 diabetes mellitus. It was first introduced by Astrazeneca Ab in its drug Kombiglyze Xr on Nov 5, 2010. 4 different companies have introduced drugs containing Metformin Hydrochloride; Saxagliptin Hydrochloride.


Metformin Hydrochloride; Saxagliptin Hydrochloride Patents

Given below is the list of patents protecting Metformin Hydrochloride; Saxagliptin Hydrochloride, 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
Kombiglyze Xr US8628799 Coated tablet formulation and method Jul 13, 2025 Astrazeneca Ab
Kombiglyze Xr US9339472 Coated tablet formulation and method Jul 13, 2025 Astrazeneca Ab
Kombiglyze Xr USRE44186 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Jul 31, 2023

(Expired)

Astrazeneca Ab
Kombiglyze Xr US6395767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method Feb 16, 2021

(Expired)

Astrazeneca Ab



Metformin Hydrochloride; Saxagliptin Hydrochloride's Family Patents

Family Patents

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Metformin Hydrochloride; Saxagliptin Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Metformin Hydrochloride; Saxagliptin Hydrochloride. The first generic version for Metformin Hydrochloride; Saxagliptin Hydrochloride was by Mylan Pharmaceuticals Inc and was approved on Jul 31, 2023. And the latest generic version is by Dr Reddys Laboratories Sa and was approved on Aug 9, 2023.

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


1. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Metformin Hydrochloride; Saxagliptin Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG; EQ 5MG BASE

tablet, extended release Prescription ORAL AB Aug 9, 2023
1GM; EQ 2.5MG BASE

tablet, extended release Prescription ORAL AB Aug 9, 2023
1GM; EQ 5MG BASE

(reference standard)

tablet, extended release Prescription ORAL AB Aug 9, 2023





2. MYLAN

Mylan Pharmaceuticals Inc has filed for 3 different strengths of generic version for Metformin Hydrochloride; Saxagliptin Hydrochloride. All of these versions come by the name SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG; EQ 5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023
1GM; EQ 2.5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023
1GM; EQ 5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





3. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Metformin Hydrochloride; Saxagliptin Hydrochloride. All of these versions come by the name SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG; EQ 5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023
1GM; EQ 2.5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023
1GM; EQ 5MG BASE

tablet, extended release Prescription ORAL AB Jul 31, 2023


Manufacturing Plant Locations
New

Sun Pharm'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 Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
India
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.