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Product profile · United States

LUMRYZ

 ·  Patent Litigation & Settlement History ↓

IngredientSODIUM OXYBATE
Application typeNDA
Application214755
Product002
Dosage formFOR SUSPENSION, EXTENDED RELEASE
RouteORAL
Strength6GM/PACKET
Approval date2023-05-01
Marketing statusPrescription
Status event—
ApplicantALKERMES INC
Product source

Current GenericRadar decision

Year2030
SelectionDEEP_REVIEW
ReviewFINAL_CHECKING
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2030-05-01
Patent anchor—
Exclusivity anchor2030-05-01
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2030. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2030-05-01. Anchor date: 2030-05-01. Patent tail: yes. Exclusivity tail: yes. Review status: FINAL_CHECKING. 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
102720622037-07-21DP ————
———
107368662037-07-21DP ————
———
109529862037-07-21U U-3601———
———
109737952037-07-21DP ————
———
110004982037-07-21DP/U U-3580———
———
110520612037-07-21DP ————
———
110652242037-07-21DP ————
———
114000652037-07-21U U-3579———
———
115043472037-07-21DP ————
———
116025122037-07-21U U-3577———
———
116025132037-07-21U U-3576———
———
117664182037-07-21DP ————
———
118263352037-07-21U U-3751———
———
118395972037-07-21DP ————
———
118965722037-07-21DP ————
———
119864512037-07-21U U-3934———
———
120971752037-07-21DP ————
———
120971762037-07-21U U-4006———
———
121091862037-07-21DP ————
———
121151422037-07-21DP ————
———
121151432037-07-21DP ————
———
121151442037-07-21DP ————
———
121151452037-07-21DP ————
———
121280212037-07-21U U-4022———
———
121382392037-07-21DP ————
———
121447932037-07-21DP ————
———
123034782037-07-21U U-4189———
———
127281102037-07-21DP ————
OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.
———
115835102042-02-07U U-3578———
———
117795572042-03-16U U-3705———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NP—2026-05-01————Source
ODE-431—2030-05-01————Source
ODE-494—2031-10-16————Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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.