Product profile · United States
GLYXAMBI
· Patent Litigation & Settlement History ↓
Current GenericRadar decision
US12433906 c13/20 broad T2D/eGFR>=30;TD base2034-04-03 plus exact-product PED.
Patent estate
| Patent | Effective date | Official listing | TRUE_DS | DS grade | Claim classification / basis | PTE | PED | Family |
|---|---|---|---|---|---|---|---|---|
| 8883805 | 2025-11-26 | DP — | N | N | SYNTHETIC_INTERMEDIATE_PROCESS | — | — | — |
| 8883805 | 2025-11-26 | DP — | N | N | SYNTHETIC_INTERMEDIATE_PROCESS Linagliptin protected synthetic intermediate and deprotection process; final drug structure in process claim does not make this an unrestricted compound claim. | — | — | — |
| 8883805 | 2026-05-26 | — — | N | N | SYNTHETIC_INTERMEDIATE_PROCESS | — | 2026-05-26 | — |
| 8883805 | 2026-05-26 | PED — | N | N | SYNTHETIC_INTERMEDIATE_PROCESS Linagliptin protected synthetic intermediate and deprotection process; final drug structure in process claim does not make this an unrestricted compound claim. | — | — | — |
| 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. | — | — | — |
| 11033552 | 2027-05-04 | DP — | N | N | FORMULATION | — | — | — |
| 11033552 | 2027-05-04 | DP — | N | N | FORMULATION Linagliptin 5 mg formulation with specified excipients and loading range. | — | — | — |
| 12178819 | 2027-05-04 | DP — | N | N | FORMULATION | — | — | — |
| 12178819 | 2027-05-04 | DP — | N | N | FORMULATION Linagliptin 5 mg formulation constrained by named diluents and excipient weight percentages. | — | — | — |
| 8673927 | 2027-05-04 | U U-1652 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 8673927 | 2027-05-04 | U U-1652 | N | N | LIMITED_COMBINATION_USE Linagliptin plus metformin for T2D; metformin is not required in every approved GLYXAMBI use. | — | — | — |
| 9173859 | 2027-05-04 | DP/U U-1772 | N | Y | DS_EQUIVALENT | — | — | — |
| 9173859 | 2027-05-04 | DP/U U-1772 | N | Y | DS_EQUIVALENT Independent claim 14 broadly claims oral tablet with linagliptin 2.5/5 mg and acceptable carrier/diluent, optionally metformin; open claim permits empagliflozin and covers the mandatory 5 mg linagliptin component of GLYXAMBI without crystal or release-system limits. | — | — | — |
| 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. | — | — | — |
| 11033552 | 2027-11-04 | — — | N | N | FORMULATION | — | 2027-11-04 | — |
| 11033552 | 2027-11-04 | PED — | N | N | FORMULATION Linagliptin 5 mg formulation with specified excipients and loading range. | — | — | — |
| 8673927 | 2027-11-04 | — — | N | N | LIMITED_COMBINATION_USE | — | 2027-11-04 | — |
| 8673927 | 2027-11-04 | PED — | N | N | LIMITED_COMBINATION_USE Linagliptin plus metformin for T2D; metformin is not required in every approved GLYXAMBI use. | — | — | — |
| 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. | — | — | — |
| 8551957 | 2029-10-14 | DP/U U-1651 | N | Y | DS_EQUIVALENT | — | — | — |
| 8551957 | 2029-10-14 | DP/U U-1651 | N | Y | DS_EQUIVALENT Independent claim 1 covers empagliflozin plus linagliptin without crystal, excipient, release-system or indication limits; the mandatory active pair spans all uses of GLYXAMBI. Not an individual new-molecule TrueDS claim. | — | — | — |
| 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. | — | — | — |
| 8551957 | 2030-04-14 | — — | N | Y | DS_EQUIVALENT | — | 2030-04-14 | — |
| 8551957 | 2030-04-14 | PED — | N | Y | DS_EQUIVALENT Independent claim 1 covers empagliflozin plus linagliptin without crystal, excipient, release-system or indication limits; the mandatory active pair spans all uses of GLYXAMBI. Not an individual new-molecule TrueDS claim. | — | — | — |
| 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. | — | — | — |
| 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-3191 | N | N | LIMITED_USE | — | — | — |
| 11090323 | 2034-04-03 | U U-3191 | N | N | LIMITED_USE Empagliflozin use restricted to reduced-eGFR subgroups and discontinuation criteria. | — | — | — |
| 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. | — | — | — |
| 12433906 | 2034-04-03 | U U-4293 | N | Y | DS_EQUIVALENT | — | — | — |
| 12433906 | 2034-04-03 | U U-4295 | N | Y | DS_EQUIVALENT | — | — | — |
| 12433906 | 2034-04-03 | U U-4296 | N | Y | DS_EQUIVALENT | — | — | — |
| 12433906 | 2034-04-03 | U U-4304 | N | Y | DS_EQUIVALENT | — | — | — |
| 12433906 | 2034-04-03 | U U-4294 | N | Y | DS_EQUIVALENT | — | — | — |
| 12433906 | 2034-04-03 | U U-4295 | N | Y | DS_EQUIVALENT 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 | Y | DS_EQUIVALENT 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 | Y | DS_EQUIVALENT 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 | Y | DS_EQUIVALENT 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 | Y | DS_EQUIVALENT 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. | — | — | — |
| 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 | Y | DS_EQUIVALENT | — | 2034-10-03 | — |
| 12433906 | 2034-10-03 | PED — | N | Y | DS_EQUIVALENT 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. | — | — | — |
| 12364700 | 2037-06-08 | U U-4224 | N | N | LIMITED_COMBINATION_USE | — | — | — |
| 12364700 | 2037-06-08 | U U-4224 | N | N | LIMITED_COMBINATION_USE Linagliptin/metformin in renal impairment with albuminuria and prior macrovascular disease; not all GLYXAMBI uses. | — | — | — |
| 12364700 | 2037-12-08 | — — | N | N | LIMITED_COMBINATION_USE | — | 2037-12-08 | — |
| 12364700 | 2037-12-08 | PED — | N | N | LIMITED_COMBINATION_USE Linagliptin/metformin in renal impairment with albuminuria and prior macrovascular disease; not all GLYXAMBI uses. | — | — | — |
Regulatory exclusivity
| Code | Start date | End date | Scope | Entire product | All indications | Full coverage date | Combination | Source |
|---|---|---|---|---|---|---|---|---|
| NCE | 2011-05-02 | 2016-05-02 | 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 | 2016-05-02 | NC + I-739
Full coverage date: 2016-05-02
| Source |
| NC | 2015-01-30 | 2018-01-30 | New empagliflozin/linagliptin fixed combination for adult T2D glycemic control; later cardiovascular benefit is mapped separately. | N | N | — | NC + I-739
Full coverage date: —
| 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 | NC + I-739
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 | — | NC + I-739
Full coverage date: —
| Source |
| M-258 | 2019-07-03 | 2022-07-03 | INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4 | N | N | — | NC + I-739
Full coverage date: —
| Source |
| M-252 | 2020-03-30 | 2023-03-30 | ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME | N | N | — | NC + I-739
Full coverage date: —
| Source |
2026-10-11 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: NOT_COMPLETE
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 |
|---|---|---|---|---|---|---|---|
| 212264 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | PRINSTON PHARMA INC | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212359 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | MSN LABS PVT LTD | N | EXACT_PRODUCT · PENDING_PRODUCT_MAPPING | Source |
| 212364 / 002 | APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED | — | — | ANNORA PHARMA | 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 (1)
| Type | Date | Role | Basis | Source |
|---|---|---|---|---|
| ANNUAL_DECISION_RECHECK | — | ANCHOR_AND_TAIL | US12433906 c13/20 broad T2D/eGFR>=30;TD base2034-04-03 plus exact-product PED. | Source |
Decision history
| Current | Year | Status | Review | Anchor | Judged |
|---|---|---|---|---|---|
| Y | 2034 | DEEP_REVIEW | FINAL | 2034-10-03 | 2026-10-17 20:32:21 |
| N | 2034 | DEEP_REVIEW | FINAL | 2034-10-03 | 2026-10-16 21:33:25 |
| N | 2030 | DEEP_REVIEW | FINAL | 2030-04-14 | 2026-10-11 18:11:30 |
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.