Product profile · United States

SYNJARDY XR

· Patent Litigation & Settlement History ↓

IngredientEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application typeNDA

Application208658

Product003

Dosage formTABLET, EXTENDED RELEASE

RouteORAL

Strength12.5MG;1GM

Approval date2016-12-09

Marketing statusRX

Status event—

ApplicantBOEHRINGER INGELHEIM

Product source

Current GenericRadar decision

Year2029

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typePATENT

Anchor date2029-02-01

Patent anchor2029-02-01

Exclusivity anchor2019-08-01

Protection date2034-12-11

First Final ANDA—

Status event—

Rights after the canonical full-scope anchor require DEEP_REVIEW.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7713938	2027-04-15	DS/DP —	N	N	CRYSTAL	—	—	—
7713938	2027-04-15	DS/DP —	N	N	CRYSTAL Empagliflozin crystalline form defined by XRPD peaks 18.84, 20.36 and 25.21; not an unrestricted compound claim.	—	—	—
7713938	2027-10-15	— —	N	N	CRYSTAL	—	2027-10-15	—
7713938	2027-10-15	PED —	N	N	CRYSTAL Empagliflozin crystalline form defined by XRPD peaks 18.84, 20.36 and 25.21; not an unrestricted compound claim.	—	—	—
7579449	2028-08-01	DS —	Y	Y	TRUE_DS	—	—	—
7579449	2028-08-01	DS —	Y	Y	TRUE_DS Broad glucopyranosyl-benzene genus plus explicit independent claim 16 identifies empagliflozin, without formulation or indication restriction. Compound protection applies to the empagliflozin component of both combinations.	—	—	—
7579449	2029-02-01	— —	Y	Y	TRUE_DS	—	2029-02-01	—
7579449	2029-02-01	PED —	Y	Y	TRUE_DS Broad glucopyranosyl-benzene genus plus explicit independent claim 16 identifies empagliflozin, without formulation or indication restriction. Compound protection applies to the empagliflozin component of both combinations.	—	—	—
12115179	2030-02-11	U U-4023	N	N	LIMITED_COMBINATION_USE	—	—	—
12115179	2030-02-11	U U-4023	N	N	LIMITED_COMBINATION_USE Empagliflozin/linagliptin/metformin triple therapy; the third agent is not mandatory across all approved product uses.	—	—	—
12115179	2030-08-11	— —	N	N	LIMITED_COMBINATION_USE	—	2030-08-11	—
12115179	2030-08-11	PED —	N	N	LIMITED_COMBINATION_USE Empagliflozin/linagliptin/metformin triple therapy; the third agent is not mandatory across all approved product uses.	—	—	—
10596120	2032-03-07	DP/U U-2775	N	N	FORMULATION	—	—	—
10596120	2032-03-07	DP/U U-2792	N	N	FORMULATION	—	—	—
10596120	2032-03-07	DP/U U-2775	N	N	FORMULATION Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	—	—	—
10596120	2032-03-07	DP/U U-2792	N	N	FORMULATION Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	—	—	—
10596120	2032-09-07	— —	N	N	FORMULATION	—	2032-09-07	—
10596120	2032-09-07	PED —	N	N	FORMULATION Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	—	—	—
10258637	2034-04-03	U U-2290	N	N	LIMITED_USE	—	—	—
10258637	2034-04-03	U U-2290	N	N	LIMITED_USE Empagliflozin diabetes treatment restricted to eGFR 45-60 and renal discontinuation criteria.	—	—	—
11090323	2034-04-03	U U-3193	N	N	LIMITED_USE	—	—	—
11090323	2034-04-03	U U-3193	N	N	LIMITED_USE Empagliflozin use restricted to reduced-eGFR subgroups and discontinuation criteria.	—	—	—
11666590	2034-04-03	U U-4154	N	N	LIMITED_USE	—	—	—
11666590	2034-04-03	U U-4154	N	N	LIMITED_USE Empagliflozin treatment/renal-outcome protection for CKD; excludes the independent glycemic and HF scopes.	—	—	—
11833166	2034-04-03	U U-3776	N	N	LIMITED_USE	—	—	—
11833166	2034-04-03	U U-3777	N	N	LIMITED_USE	—	—	—
11833166	2034-04-03	U U-3776	N	N	LIMITED_USE Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	—	—	—
11833166	2034-04-03	U U-3777	N	N	LIMITED_USE Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	—	—	—
12263153	2034-04-03	U U-4154	N	N	LIMITED_USE	—	—	—
12263153	2034-04-03	U U-4154	N	N	LIMITED_USE Empagliflozin renal/CV outcomes in CKD patients; does not cover all glycemic/HF uses.	—	—	—
12427162	2034-04-03	U U-4287	N	N	LIMITED_USE	—	—	—
12427162	2034-04-03	U U-4287	N	N	LIMITED_USE Empagliflozin renal protection restricted to stage 2-5 CKD; not all glycemic/HF product uses.	—	—	—
12433906	2034-04-03	U U-4294	N	N	MULTIPLE_USE	—	—	—
12433906	2034-04-03	U U-4295	N	N	MULTIPLE_USE	—	—	—
12433906	2034-04-03	U U-4304	N	N	MULTIPLE_USE	—	—	—
12433906	2034-04-03	U U-4293	N	N	MULTIPLE_USE	—	—	—
12433906	2034-04-03	U U-4296	N	N	MULTIPLE_USE	—	—	—
12433906	2034-04-03	U U-4295	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
12433906	2034-04-03	U U-4293	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
12433906	2034-04-03	U U-4296	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
12433906	2034-04-03	U U-4294	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
12433906	2034-04-03	U U-4304	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
9949997	2034-05-17	U U-3532	N	N	PARTIAL_INDICATION_USE	—	—	—
9949997	2034-05-17	U U-3533	N	N	PARTIAL_INDICATION_USE	—	—	—
9949997	2034-05-17	U U-3532	N	N	PARTIAL_INDICATION_USE Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	—	—	—
9949997	2034-05-17	U U-3533	N	N	PARTIAL_INDICATION_USE Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	—	—	—
9949998	2034-06-11	U U-2290	N	N	SUBPOPULATION_USE	—	—	—
9949998	2034-06-11	U U-2290	N	N	SUBPOPULATION_USE Independent claims require eGFR at least 45 and below 60 and discontinuation below 45; exclude other currently approved renal-function groups.	—	—	—
10258637	2034-10-03	— —	N	N	LIMITED_USE	—	2034-10-03	—
10258637	2034-10-03	PED —	N	N	LIMITED_USE Empagliflozin diabetes treatment restricted to eGFR 45-60 and renal discontinuation criteria.	—	—	—
11090323	2034-10-03	— —	N	N	LIMITED_USE	—	2034-10-03	—
11090323	2034-10-03	PED —	N	N	LIMITED_USE Empagliflozin use restricted to reduced-eGFR subgroups and discontinuation criteria.	—	—	—
11833166	2034-10-03	— —	N	N	LIMITED_USE	—	2034-10-03	—
11833166	2034-10-03	PED —	N	N	LIMITED_USE Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	—	—	—
12433906	2034-10-03	— —	N	N	MULTIPLE_USE	—	2034-10-03	—
12433906	2034-10-03	PED —	N	N	MULTIPLE_USE Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	—	—	—
9949997	2034-11-17	— —	N	N	PARTIAL_INDICATION_USE	—	2034-11-17	—
9949997	2034-11-17	PED —	N	N	PARTIAL_INDICATION_USE Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	—	—	—
9949998	2034-12-11	— —	N	N	SUBPOPULATION_USE	—	2034-12-11	—
9949998	2034-12-11	PED —	N	N	SUBPOPULATION_USE Independent claims require eGFR at least 45 and below 60 and discontinuation below 45; exclude other currently approved renal-function groups.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2014-08-01	2019-08-01	Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period.	Y	Y	2019-08-01	I-739 + M-296 + PED Full coverage date: 2019-08-01	Source
I-739	2016-12-02	2019-12-02	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE	N	N	—	I-739 + M-296 + PED Full coverage date: —	Source
M-296	2023-06-20	2026-06-20	Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	N	N	—	I-739 + M-296 + PED Full coverage date: —	Source
M-296	2023-06-20	2026-06-20	Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	N	N	—	I-739 + M-296 + PED Full coverage date: —	Source
PED	2026-06-20	2026-12-20	Six-month extension of M-296: Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	N	N	—	I-739 + M-296 + PED Full coverage date: —	Source
PED	2026-06-20	2026-12-20	Six-month extension of M-296: Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	N	N	—	I-739 + M-296 + PED Full coverage date: —	Source

2026-10-11 · CURRENT_AND_HISTORICAL_RECORDS · Historical coverage: NOT_COMPLETE

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

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
213654 / 003	APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED	—	—	LUPIN LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	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 0 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
No tentative-approval records are linked to this product.

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 0 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
No final-approval records are linked to this product.

Decision evidence (35)

Type	Date	Role	Basis	Source
PATENT	2027-04-15	LISTING_CONTEXT	Empagliflozin crystalline form defined by XRPD peaks 18.84, 20.36 and 25.21; not an unrestricted compound claim.	Source
PATENT	2027-10-15	LISTING_CONTEXT	Empagliflozin crystalline form defined by XRPD peaks 18.84, 20.36 and 25.21; not an unrestricted compound claim.	Source
PATENT	2028-08-01	LISTING_CONTEXT	Broad glucopyranosyl-benzene genus plus explicit independent claim 16 identifies empagliflozin, without formulation or indication restriction. Compound protection applies to the empagliflozin component of both combinations.	Source
PATENT	2029-02-01	CANONICAL_ANCHOR	Broad glucopyranosyl-benzene genus plus explicit independent claim 16 identifies empagliflozin, without formulation or indication restriction. Compound protection applies to the empagliflozin component of both combinations.	Source
PATENT	2030-02-11	FTO_TAIL	Empagliflozin/linagliptin/metformin triple therapy; the third agent is not mandatory across all approved product uses.	Source
PATENT	2030-08-11	FTO_TAIL	Empagliflozin/linagliptin/metformin triple therapy; the third agent is not mandatory across all approved product uses.	Source
PATENT	2032-03-07	FTO_TAIL	Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	Source
PATENT	2032-03-07	FTO_TAIL	Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	Source
PATENT	2032-09-07	FTO_TAIL	Layered extended-release metformin and immediate-release empagliflozin tablet architecture.	Source
PATENT	2034-04-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-04-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin diabetes treatment restricted to eGFR 45-60 and renal discontinuation criteria.	Source
PATENT	2034-04-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-04-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin renal/CV outcomes in CKD patients; does not cover all glycemic/HF uses.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin renal protection restricted to stage 2-5 CKD; not all glycemic/HF product uses.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin use restricted to reduced-eGFR subgroups and discontinuation criteria.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	Source
PATENT	2034-04-03	FTO_TAIL	Empagliflozin treatment/renal-outcome protection for CKD; excludes the independent glycemic and HF scopes.	Source
PATENT	2034-04-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-05-17	FTO_TAIL	Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	Source
PATENT	2034-05-17	FTO_TAIL	Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	Source
PATENT	2034-06-11	FTO_TAIL	Independent claims require eGFR at least 45 and below 60 and discontinuation below 45; exclude other currently approved renal-function groups.	Source
PATENT	2034-10-03	FTO_TAIL	Independent claims include broader eGFR-at-least-30 T2D treatment as well as renal subgroups; glycemic scope alone does not establish all current cardiovascular/HF/CKD indication coverage.	Source
PATENT	2034-10-03	FTO_TAIL	Empagliflozin diabetes treatment restricted to eGFR 45-60 and renal discontinuation criteria.	Source
PATENT	2034-10-03	FTO_TAIL	Empagliflozin glycemic treatment restricted to impaired-eGFR patient subgroups.	Source
PATENT	2034-10-03	FTO_TAIL	Empagliflozin use restricted to reduced-eGFR subgroups and discontinuation criteria.	Source
PATENT	2034-11-17	FTO_TAIL	Independent claims address cardiovascular death, HF hospitalization or all-cause mortality in T2D with cardiovascular disease; not all glycemic, HF and CKD populations.	Source
PATENT	2034-12-11	FTO_TAIL	Independent claims require eGFR at least 45 and below 60 and discontinuation below 45; exclude other currently approved renal-function groups.	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_CONTEXT	Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_CONTEXT	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE	Source
REGULATORY_EXCLUSIVITY	—	SCOPE_CONTEXT	Six-month extension of M-296: Results of protocol 1218-0091 added to labeling; this is clinical/pediatric-study information, not whole adult XR glycemic, HF, CKD and cardiovascular scope protection.	Source
REGULATORY_EXCLUSIVITY	2019-08-01	CANONICAL_ANCHOR	Active-moiety NCE protection; applies to all uses of the mandatory active component, including this exact product during the remaining component protection period.	Source
REGULATORY_STATUS	2029-02-01	DECISION_BASIS	Rights after the canonical full-scope anchor require DEEP_REVIEW.	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.