Market LIVE
Published markets; coverage varies by country
Product profile · United States

GIAPREZA

 ·  Patent Litigation & Settlement History ↓

IngredientANGIOTENSIN II ACETATE
Application typeNDA
Application209360
Product003
Dosage formSOLUTION
RouteINTRAVENOUS
StrengthEQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)
Approval date2021-12-23
Marketing statusPrescription
Status event—
ApplicantLA JOLLA PHARMA
Product source

Current GenericRadar decision

Year2022
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2022-12-21
Patent anchor—
Exclusivity anchor2022-12-21
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2022. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2022-12-21. Anchor date: 2022-12-21. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
103354512029-12-16U U-2581———
———
105002472029-12-16U U-2680———
———
105002472029-12-16U U-2681———
———
105489432029-12-16U U-2740———
———
105489432029-12-16U U-2739———
———
98678632029-12-16U U-2231———
———
95728562031-07-18U U-2221———
———
100289952034-12-18U U-2338———
———
104931242034-12-18U U-2679———
———
110969832034-12-18U U-3211———
———
110969832034-12-18U U-3212———
———
115595592034-12-18U U-3514———
———
92207452034-12-18U U-2217———
———
92207452034-12-18U U-2218———
———
112196622037-01-06U U-3262———
———

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.
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.