Product profile · United States

PROMACTA

· Patent Litigation & Settlement History ↓

IngredientELTROMBOPAG OLAMINE

Application typeNDA

Application022291

Product004

Dosage formTABLET

RouteORAL

StrengthEQ 12.5MG ACID

Approval date2011-10-20

Marketing statusPrescription

Status event—

ApplicantNOVARTIS

Product source

Current GenericRadar decision

Year2025

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2025-01-17

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2025-01-17

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

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
7547719	2025-07-13	DS/DP/U U-2452	—	—	—	—	—	—
7547719	2025-07-13	DS/DP/U U-1306	—	—	—	—	—	—
7547719	2025-07-13	DS/DP/U U-2451	—	—	—	—	—	—
7547719	2025-07-13	DS/DP/U U-1575	—	—	—	—	—	—
7547719	2026-01-13	— —	—	—	—	—	2026-01-13	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
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 / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
206788 / 001	FINAL_APPROVAL · FINAL_APPROVED	2025-01-17	—	HETERO LABS LTD UNIT V	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
212884 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	—	AMNEAL EU LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
216281 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	—	ZYDUS PHARMACEUTICALS USA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
219638 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	—	SOMERSET THERAPEUTICS LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
220250 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	—	MSN LABORATORIES PRIVATE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
219121 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-03-16	—	DR REDDYS LABORATORIES LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
220033 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-04-08	—	HIKMA PHARMACEUTICALS USA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
220660 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-04-28	—	BIOCON PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209938 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-07-13	—	TEVA PHARMACEUTICALS USA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source

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 9 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
206788 / 001	HETERO LABS LTD UNIT V	FINAL_APPROVAL · FINAL_APPROVED	2025-01-17	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
212884 / 001	AMNEAL EU LTD	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
216281 / 001	ZYDUS PHARMACEUTICALS USA INC	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
219638 / 001	SOMERSET THERAPEUTICS LLC	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
220250 / 001	MSN LABORATORIES PRIVATE LTD	FINAL_APPROVAL · FINAL_APPROVED	2026-01-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
219121 / 001	DR REDDYS LABORATORIES LTD	FINAL_APPROVAL · FINAL_APPROVED	2026-03-16	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
220033 / 001	HIKMA PHARMACEUTICALS USA INC	FINAL_APPROVAL · FINAL_APPROVED	2026-04-08	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
220660 / 001	BIOCON PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2026-04-28	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209938 / 001	TEVA PHARMACEUTICALS USA INC	FINAL_APPROVAL · FINAL_APPROVED	2026-07-13	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
GENERIC	2025-01-17	TERMINAL_GENERIC_BASIS	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.	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.