Product profile · United States

ZEPZELCA

· Patent Litigation & Settlement History ↓

IngredientLURBINECTEDIN

Application typeNDA

Application213702

Product001

Dosage formPOWDER

RouteINTRAVENOUS

Strength4MG/VIAL

Approval date2020-06-15

Marketing statusPrescription

Status event—

ApplicantJAZZ

Product source

Current GenericRadar decision

Year2029

SelectionCANDIDATE

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2029-12-13

Patent anchor2029-12-13

Exclusivity anchor2028-10-02

Protection date2029-12-13

First Final ANDA—

Status event—

ZEPZELCA approved 2020-06-15. Former monotherapy indication withdrawn 2026-09-30. Current approved indication is atezolizumab maintenance combination. US12324806, US12433890 and US12440490 require monotherapy and are delist-requested in FDA OB; preserve patent history but do not apply them to the current maintenance combination. US7763615 DS/PTE anchor 2029-12-13. I-977 through 2028-10-02 is earlier. OOPD end TBD and pending combination applications do not create an invented later date. CANDIDATE on verified current-product rights; not global FTO clearance.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7763615	2029-12-13	DS/DP/U U-4299	Y	N	TRUE_DS \| B1C0201 issued-claim review2026-10-14: TRUE_DS	—	—	—
7763615	2029-12-13	DS/DP/U U-2836	Y	N	TRUE_DS \| B1C0201 issued-claim review2026-10-14: TRUE_DS	—	—	—
7763615	2029-12-13	ORANGE_BOOK U-2836 / U-4299	Y	N	TRUE_DS English description not available.	—	—	—
12324806	2040-05-29	U U-4212	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12324806	2040-05-29	ORANGE_BOOK U-4212	N	N	U English description not available.	—	—	—
12324806	2040-05-29	U U-4212	—	—	— OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.	—	—	—
12433890	2040-05-29	U U-4305	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12433890	2040-05-29	ORANGE_BOOK U-4305	N	N	U English description not available.	—	—	—
12433890	2040-05-29	U U-4305	—	—	— OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.	—	—	—
12440490	2040-05-29	U U-4252	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12440490	2040-05-29	ORANGE_BOOK U-4252	N	N	U English description not available.	—	—	—
12440490	2040-05-29	U U-4252	—	—	— OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2020-06-15	2025-06-15	English description not available.	Y	Y	2025-06-15		Source
ODE-304	2020-06-15	2027-06-15	English description not available.	N	N	—	—	Source
ODE-304	2020-06-15	2027-06-15	English description not available.	N	N	—		Source
I-977	2025-10-02	2028-10-02	English description not available.	Y	Y	2028-10-02	—	Source
I-977	2025-10-02	2028-10-02	English description not available.	Y	Y	2028-10-02		Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
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.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last 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 / product	Applicant	Event / status	First marketed	Product mapping	Source	Last 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 / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last 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 / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last 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 / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
No final-approval records are linked to this product.

Decision evidence (1)

Type	Date	Role	Basis	Source
PATENT	2029-12-13	CANONICAL_ANCHOR	ZEPZELCA approved 2020-06-15. Former monotherapy indication withdrawn 2026-09-30. Current approved indication is atezolizumab maintenance combination. US12324806, US12433890 and US12440490 require monotherapy and are delist-requested in FDA OB; preserve patent history but do not apply them to the current maintenance combination. US7763615 DS/PTE anchor 2029-12-13. I-977 through 2028-10-02 is earlier. OOPD end TBD and pending combination applications do not create an invented later date. CANDIDATE on verified current-product rights; not global FTO clearance.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2029	CANDIDATE	FINAL	2029-12-13	2026-10-16 20:15:15
N	2029	DEEP_REVIEW	FINAL	2029-12-13	2026-10-14 05:05:00

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.