GenericRadar
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Product profile · United States

RAVICTI

 ·  Patent Litigation & Settlement History ↓

IngredientGLYCEROL PHENYLBUTYRATE
Application typeNDA
Application203284
Product001
Dosage formLIQUID
RouteORAL
Strength1.1GM/ML
Approval date2013-02-01
Marketing statusPrescription
Status event—
ApplicantHORIZON THERAP US
Product source

Current GenericRadar decision

Year2021
SelectionEXISTING_GENERIC
ReviewDISQUALIFIED
Anchor typeFINAL_ANDA
Anchor date2021-12-02
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2021-12-02
Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100459582030-09-22U U-1816———
———
100459592030-09-22U U-1816———
———
101830022030-09-22U U-1816———
———
101830032030-09-22U U-1816———
———
101830042030-09-22U U-1816———
———
101830052030-09-22U U-1816———
———
101830062030-09-22U U-1816———
———
106680402030-09-22U U-1816———
———
86420122030-09-22U U-1383———
———
92542782030-09-22U U-1816———
———
93269662030-09-22U U-1816———
———
95611972030-09-22U U-1383———
———
99623592030-09-22U U-1816———
———
99996082030-09-22U U-1816———
———

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
205742 / 001FINAL_APPROVAL · FINAL_APPROVED2021-12-02—PH HEALTH LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218738 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-15—TEVA PHARMACEUTICALS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
219540 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-15—MSN LABORATORIES PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
220313 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-15—AUROBINDO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
220568 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-23—NAVINTA LLCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
207694 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-30—LUPIN LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
220579 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMANEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource

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 7 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
205742 / 001PH HEALTH LTDFINAL_APPROVAL · FINAL_APPROVED2021-12-02 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218738 / 001TEVA PHARMACEUTICALS INCFINAL_APPROVAL · FINAL_APPROVED2026-04-15 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
219540 / 001MSN LABORATORIES PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-15 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
220313 / 001AUROBINDO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-15 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
220568 / 001NAVINTA LLCFINAL_APPROVAL · FINAL_APPROVED2026-04-23 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
207694 / 001LUPIN LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-30 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
220579 / 001PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMAFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (1)
TypeDateRoleBasisSource
GENERIC2021-12-02TERMINAL_GENERIC_BASISExact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.Source
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.