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Product profile · United States

UPTRAVI

 ·  Patent Litigation & Settlement History ↓

IngredientSELEXIPAG
Application typeNDA
Application214275
Product001
Dosage formPOWDER
RouteINTRAVENOUS
Strength1.8MG/VIAL
Approval date2021-07-29
Marketing statusPrescription
Status event—
ApplicantACTELION
Product source

Current GenericRadar decision

Year2027
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2027-04-30
Patent anchor2027-04-30
Exclusivity anchor2022-12-21
Protection date2031-02-01
First Final ANDA—
Status event—

POST_ANCHOR_TAIL; Canonical 2027-04-30; latest tail 2031-02-01

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
72053022026-10-31DS/DP/U U-1797———
———
72053022027-04-30— ————
—2027-04-30—
72053022027-04-30ORANGE_BOOK U-1797YNTRUE_DS
Independent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.
—2027-04-30—
91738812029-08-12U U-1798———
———
91738812030-02-12— ————
—2030-02-12—
91738812030-02-12ORANGE_BOOK U-1798NNU
Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.
—2030-02-12—
92842802030-06-25U U-1831———
———
87911222030-08-01DS/DP ————
———
92842802030-12-25— ————
—2030-12-25—
92842802030-12-25ORANGE_BOOK U-1831NNU
Process or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.
—2030-12-25—
87911222031-02-01— ————
—2031-02-01—
87911222031-02-01ORANGE_BOOK —NNDP
Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.
—2031-02-01—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
ODE*2015-12-212022-12-21English description not available.YY2022-12-21Source

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 (6)
TypeDateRoleBasisSource
PATENT2027-04-30CANONICAL_ANCHORIndependent chemical compound claim; no mandatory polymorph/formulation limitation. Matched to FDA exact-product estate.Source
PATENT2030-02-12FTO_TAILProcess or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.Source
PATENT2030-12-25FTO_TAILProcess or use limited to a particular indication, combination, regimen, population or formulation; not whole-label anchor.Source
PATENT2031-02-01FTO_TAILComposition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2027-04-30CANONICAL_DECISIONPOST_ANCHOR_TAIL; Canonical 2027-04-30; latest tail 2031-02-01Source
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.