GenericRadar
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Product profile · United States

PROCYSBI

 ·  Patent Litigation & Settlement History ↓

IngredientCYSTEAMINE BITARTRATE
Application typeNDA
Application203389
Product001
Dosage formCAPSULE, DELAYED RELEASE
RouteORAL
StrengthEQ 25MG BASE
Approval date2013-04-30
Marketing statusPrescription
Status event—
ApplicantHORIZON
Product source

Current GenericRadar decision

Year2028
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2028-03-22
Patent anchor2028-03-22
Exclusivity anchor2020-10-30
Protection date2037-02-16
First Final ANDA—
Status event—

POST_ANCHOR_TAIL; Canonical 2028-03-22; latest tail 2037-02-16

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
91925902027-01-26U U-1399———
———
91988822027-01-26U U-1399———
———
99251562027-01-26DS/DP/U U-1399———
———
99251572027-01-26DS/DP/U U-1399———
———
99251582027-01-26DS/DP/U U-1399———
———
91925902027-07-26— ————
—2027-07-26—
91925902027-07-26ORANGE_BOOK U-1399NNU
English description not available.
—2027-07-26—
91988822027-07-26— ————
—2027-07-26—
91988822027-07-26ORANGE_BOOK U-1399NYDS_EQUIVALENT
English description not available.
—2027-07-26—
99251562027-07-26— ————
—2027-07-26—
99251562027-07-26ORANGE_BOOK U-1399NNDP
English description not available.
—2027-07-26—
99251572027-07-26— ————
—2027-07-26—
99251572027-07-26ORANGE_BOOK U-1399NNDP
English description not available.
—2027-07-26—
99251582027-07-26— ————
—2027-07-26—
99251582027-07-26ORANGE_BOOK U-1399NNDP
English description not available.
—2027-07-26—
80262842027-09-22U U-1399———
———
80262842028-03-22— ————
—2028-03-22—
80262842028-03-22ORANGE_BOOK U-1399NYDS_EQUIVALENT
English description not available.
—2028-03-22—
91738512034-06-17DP ————
———
92330772034-06-17DP ————
———
91738512034-12-17— ————
—2034-12-17—
91738512034-12-17ORANGE_BOOK —NNDP
English description not available.
—2034-12-17—
92330772034-12-17— ————
—2034-12-17—
92330772034-12-17ORANGE_BOOK —NNDP
English description not available.
—2034-12-17—
101436652036-08-16U U-1399———
———
103280372036-08-16U U-1399———
———
105488592036-08-16U U-1399———
———
109056622036-08-16U U-1399———
———
101436652037-02-16— ————
—2037-02-16—
101436652037-02-16ORANGE_BOOK U-1399NNU
English description not available.
—2037-02-16—
103280372037-02-16— ————
—2037-02-16—
103280372037-02-16ORANGE_BOOK U-1399NNU
English description not available.
—2037-02-16—
105488592037-02-16— ————
—2037-02-16—
105488592037-02-16ORANGE_BOOK U-1399NNU
English description not available.
—2037-02-16—
109056622037-02-16— ————
—2037-02-16—
109056622037-02-16ORANGE_BOOK U-1399NNU
English description not available.
—2037-02-16—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NDF2013-04-302016-04-30English description not available.NN—Source
NPP2015-08-142018-08-14NEW PATIENT POPULATIONNN—Source
ODE2013-04-302020-04-30English description not available.NN—Source
ODE-452013-04-302020-04-30English description not available.NN—Source
PED2020-04-302020-10-30English description not available.NN—Source
M-2162017-12-222020-12-22UPDATE THE PRESCRIBING INFORMATION AND PATIENT LABELING WITH FINDINGS FROM STUDY RP103-08 CONDUCTED IN TREATMENT-NAIVE NEPHROPATHIC CYSTINOSIS PATIENTS TO EXPAND THE INDICATED POPULATION TO PATIENTS 1 YEAR AND OLDERNN—Source
PED2020-12-222021-06-22English description not available.NN—Source
ODE2015-08-142022-08-14English description not available.NN—Source
ODE-972015-08-142022-08-14English description not available.NN—Source
PED2022-08-142023-02-14English description not available.NN—Source
ODE-1622017-12-222024-12-22English description not available.NN—Source
PED2024-12-222025-06-22English description not available.NN—Source

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 (25)
TypeDateRoleBasisSource
PATENT2027-07-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-07-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-07-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-07-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-07-26HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-03-22CANONICAL_ANCHOREnglish description not available.Source
PATENT2034-12-17FTO_TAILEnglish description not available.Source
PATENT2034-12-17FTO_TAILEnglish description not available.Source
PATENT2037-02-16FTO_TAILEnglish description not available.Source
PATENT2037-02-16FTO_TAILEnglish description not available.Source
PATENT2037-02-16FTO_TAILEnglish description not available.Source
PATENT2037-02-16FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTUPDATE THE PRESCRIBING INFORMATION AND PATIENT LABELING WITH FINDINGS FROM STUDY RP103-08 CONDUCTED IN TREATMENT-NAIVE NEPHROPATHIC CYSTINOSIS PATIENTS TO EXPAND THE INDICATED POPULATION TO PATIENTS 1 YEAR AND OLDERSource
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTNEW PATIENT POPULATIONSource
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2028-03-22CANONICAL_DECISIONPOST_ANCHOR_TAIL; Canonical 2028-03-22; latest tail 2037-02-16Source
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.