Product profile · United States

REVTORPYK

· Patent Litigation & Settlement History ↓

IngredientGEDATOLISIB

Application typeNDA

Application219908

Product001

Dosage formPOWDER

RouteINTRAVENOUS

Strength180MG/VIAL

Approval date2026-07-14

Marketing statusPrescription

Status event—

ApplicantCELCUITY

Product source

Current GenericRadar decision

Year2031

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeREGULATORY_EXCLUSIVITY

Anchor date2031-07-14

Patent anchor2029-12-17

Exclusivity anchor2031-07-14

Protection date2042-08-31

First Final ANDA—

Status event—

Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
US8039469	2029-12-17	CLAIM_REVIEW_NOT_EXACT_OB_LISTING —	Y	N	TRUE_DS Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.	—	—	—
US12350276	2042-08-31	CLAIM_REVIEW_NOT_EXACT_OB_LISTING —	N	N	U Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	—	2031-07-14	Active-moiety submission/approval barrier across uses.	Y	Y	—	—	Source
NCE	2026-07-14	2031-07-14	Active-moiety submission/approval barrier across uses.	Y	Y	2031-07-14	—	Source

2026-10-13 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_AND_MONTHLY_REVIEWED

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 (4)

Type	Date	Role	Basis	Source
PATENT	2029-12-17	CANONICAL_ANCHOR	Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.	Source
PATENT	2042-08-31	FTO_TAIL	Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.	Source
REGULATORY_EXCLUSIVITY	2031-07-14	CANONICAL_ANCHOR	Active-moiety submission/approval barrier across uses.	Source
REGULATORY_STATUS	2031-07-14	CANONICAL_DECISION	Gedatolisib original compound term 2029-12-17 (2009-05-22 plus 209 PTA days) precedes NCE. US12350276 independent claims require concurrent CDK4/6 inhibitor, while FDA permits fulvestrant with OR without palbociclib. Classify partial U, not DS-equivalent. Its 2022-07-25 plus 37-day PTA term is 2042-08-31. Cyclodextrin formulation rights remain separate.	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.