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Product profile · United States

TRIJARDY XR

 ·  Patent Litigation & Settlement History ↓

IngredientEMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Application typeNDA
Application212614
Product003
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
Strength12.5MG;2.5MG;1GM
Approval date2020-01-27
Marketing statusPrescription
Status event—
ApplicantBOEHRINGER INGELHEIM
Product source

Current GenericRadar decision

Year2034
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2034-04-03
Patent anchor2034-04-03
Exclusivity anchor—
Protection date2037-12-08
First Final ANDA—
Status event—

US12433906 c13/20 applies despite nonlisting;TD2025-05-16 checked. No copied PED;2030 claim withdrawn.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
88838052025-11-26DP ————
———
88838052026-05-26— ————
—2026-05-26—
88838052026-05-26ORANGE_BOOK —YNTRUE_DS
English description not available.
—2026-05-26—
77139382027-04-15DS/DP ————
———
77139382027-10-15— ————
—2027-10-15—
77139382027-10-15ORANGE_BOOK —NNDP
English description not available.
—2027-10-15—
75794492028-08-01DS ————
———
75794492029-02-01— ————
—2029-02-01—
75794492029-02-01ORANGE_BOOK —YNTRUE_DS
English description not available.
—2029-02-01—
100223792029-04-02DP/U U-2732———
———
100223792029-04-02ORANGE_BOOK U-2732NNDP
English description not available.
———
126784422029-04-02DP ————
———
94150162029-04-02DP ————
———
94150162029-04-02ORANGE_BOOK —NNDP
English description not available.
———
126784422029-10-02— ————
—2029-10-02—
126784422029-10-02ORANGE_BOOK —NNDP
English description not available.
—2029-10-02—
85519572029-10-14DP/U U-2730———
———
121151792030-02-11U U-4023———
———
85519572030-04-14— ————
—2030-04-14—
85519572030-04-14ORANGE_BOOK U-2730NYDS_EQUIVALENT
English description not available.
—2030-04-14—
91557052030-05-21DP ————
———
91557052030-05-21ORANGE_BOOK —NNDP
English description not available.
———
104061722030-06-15DP/U U-2733———
———
104061722030-06-15ORANGE_BOOK U-2733NYDS_EQUIVALENT
English description not available.
———
121151792030-08-11— ————
—2030-08-11—
121151792030-08-11ORANGE_BOOK U-4023NYDS_EQUIVALENT
English description not available.
—2030-08-11—
105961202032-03-07DP/U U-2790———
———
105961202032-03-07DP/U U-2776———
———
105961202032-03-07ORANGE_BOOK U-2776,U-2790NNDP
English description not available.
———
115648862032-03-07DP/U U-3531———
———
115648862032-03-07ORANGE_BOOK U-3531NNDP
English description not available.
———
102586372034-04-03U U-2731———
———
110903232034-04-03U U-3192———
———
118331662034-04-03U U-3776———
———
118331662034-04-03U U-3777———
———
99499982034-06-11U U-2731———
———
102586372034-10-03— ————
—2034-10-03—
102586372034-10-03ORANGE_BOOK U-2731NNU
English description not available.
—2034-10-03—
110903232034-10-03— ————
—2034-10-03—
110903232034-10-03ORANGE_BOOK U-3192NNU
English description not available.
—2034-10-03—
118331662034-10-03— ————
—2034-10-03—
118331662034-10-03ORANGE_BOOK U-3776,U-3777NNU
English description not available.
—2034-10-03—
99499982034-12-11— ————
—2034-12-11—
99499982034-12-11ORANGE_BOOK U-2731NNU
English description not available.
—2034-12-11—
123647002037-06-08U U-4224———
———
123647002037-12-08— ————
—2037-12-08—
123647002037-12-08ORANGE_BOOK U-4224NNU
English description not available.
—2037-12-08—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

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

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

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.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast 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 / productApplicantEvent / status First marketed Product mappingSourceLast 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 / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast 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 / productApplicantEvent / status Certification event date Product mappingSourceLast 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 / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Decision evidence (1)
TypeDateRoleBasisSource
ANNUAL_DECISION_RECHECK—ANCHOR_AND_TAILUS12433906 c13/20 applies despite nonlisting;TD2025-05-16 checked. No copied PED;2030 claim withdrawn.Source
Decision history
CurrentYearStatusReviewAnchorJudged
Y2034DEEP_REVIEWFINAL2034-04-032026-10-17 20:32:21
N2034DEEP_REVIEWFINAL2034-04-032026-10-16 21:33:25
N2030DEEP_REVIEWFINAL2030-08-112026-10-13 23:50:30
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.