Product profile · United States

QTERN

· Patent Litigation & Settlement History ↓

IngredientDAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Application typeNDA

Application209091

Product001

Dosage formTABLET

RouteORAL

Strength10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval date2017-02-27

Marketing statusDISCONTINUED

Status event—

ApplicantASTRAZENECA AB

Product source

Current GenericRadar decision

Year2026

SelectionDISQUALIFIED

ReviewFINAL

Anchor typeFIRST_FINAL_ANDA

Anchor date2026-04-06

Patent anchor2026-04-04

Exclusivity anchor2022-05-02

Protection date2030-06-16

First Final ANDA2026-04-06

Status event—

EXISTING_GENERIC; Final ANDA211533/001,2026-04-06, exact QTERN10/5mg

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
6515117	2025-10-04	DS/DP/U U-493	—	—	—	—	—	—
6515117	2026-04-04	— —	—	—	—	—	2026-04-04	—
6515117	2026-04-04	ORANGE_BOOK U-493	Y	N	TRUE_DS English description not available.	—	2026-04-04	—
8501698	2027-06-20	DP/U U-493	—	—	—	—	—	—
8501698	2027-06-20	DP/U U-1976	—	—	—	—	—	—
8501698	2027-06-20	DP/U U-1977	—	—	—	—	—	—
8501698	2027-12-20	— —	—	—	—	—	2027-12-20	—
8501698	2027-12-20	ORANGE_BOOK U-1976,U-1977,U-493	N	N	DP English description not available.	—	2027-12-20	—
8221786	2028-03-21	DP —	—	—	—	—	—	—
8361972	2028-03-21	U U-493	—	—	—	—	—	—
8361972	2028-03-21	U U-1976	—	—	—	—	—	—
8361972	2028-03-21	U U-1977	—	—	—	—	—	—
8716251	2028-03-21	DP —	—	—	—	—	—	—
8221786	2028-09-21	— —	—	—	—	—	2028-09-21	—
8221786	2028-09-21	ORANGE_BOOK —	N	N	DP English description not available.	—	2028-09-21	—
8361972	2028-09-21	— —	—	—	—	—	2028-09-21	—
8361972	2028-09-21	ORANGE_BOOK U-1976,U-1977,U-493	N	N	U English description not available.	—	2028-09-21	—
8716251	2028-09-21	— —	—	—	—	—	2028-09-21	—
8716251	2028-09-21	ORANGE_BOOK —	N	N	DP English description not available.	—	2028-09-21	—
7919598	2029-12-16	DS —	—	—	—	—	—	—
7919598	2030-06-16	— —	—	—	—	—	2030-06-16	—
7919598	2030-06-16	ORANGE_BOOK —	N	N	DP English description not available.	—	2030-06-16	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Source
NCE	2014-01-08	2019-01-08	NEW CHEMICAL ENTITY	Y	Y	2019-01-08	Source
M-175	2016-04-05	2019-04-05	INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES	N	N	—	Source
NC	2017-02-27	2020-02-27	English description not available.	N	N	—	Source
I-804	2019-05-02	2022-05-02	English description not available.	Y	Y	2022-05-02	Source

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
211533 / 001	FINAL_APPROVAL · FINAL_APPROVAL	2026-04-06	2025-09-05	MSN Laboratories Private Limited	N	EXACT_PRODUCT · VERIFIED	Source

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 1 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
211533 / 001	MSN Laboratories Private Limited	FINAL_APPROVAL · FINAL_APPROVAL	2025-09-05	Final approval recorded	EXACT_PRODUCT · VERIFIED	Source	—

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 1 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
211533 / 001	MSN Laboratories Private Limited	FINAL_APPROVAL · FINAL_APPROVAL	2026-04-06	EXACT_PRODUCT · VERIFIED	Source	—

Decision evidence (12)

Type	Date	Role	Basis	Source
GENERIC_APPROVAL	2026-04-06	TERMINAL_STATUS	FDA Final ANDA211533 exact QTERN10/5mg; signature/AP2026-04-06	Source
PATENT	2026-04-04	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2027-12-20	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2028-09-21	HISTORICAL_CONTEXT	English description not available.	Source
PATENT	2030-06-16	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	English description not available.	Source
REGULATORY_EXCLUSIVITY	—	HISTORICAL_CONTEXT	NEW CHEMICAL ENTITY	Source
REGULATORY_STATUS	2026-04-06	TERMINAL_STATUS	EXISTING_GENERIC; Final ANDA211533/001,2026-04-06, exact QTERN10/5mg	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.