KOMBIGLYZE XR Drug Patent Profile
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Which patents cover Kombiglyze Xr, and what generic alternatives are available?
Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-seven patent family members in thirty-two countries.
The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kombiglyze Xr
A generic version of KOMBIGLYZE XR was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9th, 2023.
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Questions you can ask:
- What is the 5 year forecast for KOMBIGLYZE XR?
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Summary for KOMBIGLYZE XR
International Patents: | 57 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 3 |
Patent Applications: | 54 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KOMBIGLYZE XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KOMBIGLYZE XR |
DailyMed Link: | KOMBIGLYZE XR at DailyMed |
![KOMBIGLYZE XR drug patent expirations Drug patent expirations by year for KOMBIGLYZE XR](/p/graph/s/t/KOMBIGLYZE_XR-patent-expirations.png)
![Drug Prices for KOMBIGLYZE XR](/p/graph/drug-price/KOMBIGLYZE+XR.png)
Recent Clinical Trials for KOMBIGLYZE XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Basrah | N/A |
Karolinska Institutet | Phase 3 |
The First Affiliated Hospital of Guangzhou Medical University | Phase 3 |
Pharmacology for KOMBIGLYZE XR
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KOMBIGLYZE XR | Extended-release Tablets | metformin hydrochloride; saxagliptin hydrochloride | 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg | 200678 | 3 | 2013-07-31 |
US Patents and Regulatory Information for KOMBIGLYZE XR
KOMBIGLYZE XR is protected by two US patents.
Patents protecting KOMBIGLYZE XR
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Expired US Patents for KOMBIGLYZE XR
International Patents for KOMBIGLYZE XR
See the table below for patents covering KOMBIGLYZE XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20030036140 | ⤷ Sign Up | |
Malaysia | 147639 | COATED TABLET FORMULATION AND METHOD | ⤷ Sign Up |
Peru | 20020771 | PIRROLIDINA FUSIONADA CON CICLOPROPILO COMO INHIBIDORES DE DIPEPTIDIL PEPTIDAS IV | ⤷ Sign Up |
Singapore | 152030 | CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV AND METHOD | ⤷ Sign Up |
Japan | 4460205 | ⤷ Sign Up | |
China | 1213028 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KOMBIGLYZE XR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2498758 | 122020000018 | Germany | ⤷ Sign Up | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1532149 | PA2012022 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
2498758 | LUC00152 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
1532149 | 92128 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
1261586 | C01261586/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329 |
1506211 | 92496 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |