Product profile · United States

POTASSIUM CHLORIDE

· Patent Litigation & Settlement History ↓

IngredientPOTASSIUM CHLORIDE

Application typeNDA

Application206814

Product002

Dosage formSOLUTION

RouteORAL

Strength40MEQ/15ML

Approval date2014-12-22

Marketing statusPrescription

Status event—

ApplicantGENUS LIFESCIENCES

Product source

Current GenericRadar decision

Year2018

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2018-07-19

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2018-07-19

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
12539314	2039-03-07	DP —	—	—	—	—	—	—
12728138	2039-03-07	DP —	—	—	— 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
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
210041 / 002	FINAL_APPROVAL · FINAL_APPROVED	2018-07-19	—	AMNEAL PHARMACEUTICALS LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211067 / 002	FINAL_APPROVAL · FINAL_APPROVED	2018-08-08	—	APOTEX INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
209786 / 002	FINAL_APPROVAL · FINAL_APPROVED	2018-08-29	—	NOVEL LABORATORIES INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
210766 / 002	FINAL_APPROVAL · FINAL_APPROVED	2019-03-29	—	PHARMACEUTICAL ASSOCIATES INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
213392 / 002	FINAL_APPROVAL · FINAL_APPROVED	2021-01-29	—	GRANULES PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211648 / 002	FINAL_APPROVAL · FINAL_APPROVED	2021-05-21	—	SCIEGEN PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214656 / 002	FINAL_APPROVAL · FINAL_APPROVED	2022-01-13	—	RUBICON RESEARCH LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214076 / 002	FINAL_APPROVAL · FINAL_APPROVED	2022-01-26	—	TRIS PHARMA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
213062 / 002	FINAL_APPROVAL · FINAL_APPROVED	2022-06-06	—	WES PHARMA INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211665 / 001	FINAL_APPROVAL · FINAL_APPROVED	2022-11-17	—	STRIDES PHARMA GLOBAL PTE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214892 / 002	FINAL_APPROVAL · FINAL_APPROVED	2022-12-30	—	ADAPTIS PHARMA PRIVATE LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
216156 / 002	FINAL_APPROVAL · FINAL_APPROVED	2023-03-07	—	AJENAT PHARMACEUTICALS LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211992 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-04-09	—	ASCENT PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
218733 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-09-10	—	MACLEODS PHARMACEUTICALS LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
216536 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-11-20	—	AUROBINDO PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
215716 / 002	FINAL_APPROVAL · FINAL_APPROVED	2025-12-22	—	QUAGEN PHARMACEUTICALS LLC	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 16 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
210041 / 002	AMNEAL PHARMACEUTICALS LLC	FINAL_APPROVAL · FINAL_APPROVED	2018-07-19	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211067 / 002	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2018-08-08	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
209786 / 002	NOVEL LABORATORIES INC	FINAL_APPROVAL · FINAL_APPROVED	2018-08-29	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
210766 / 002	PHARMACEUTICAL ASSOCIATES INC	FINAL_APPROVAL · FINAL_APPROVED	2019-03-29	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
213392 / 002	GRANULES PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2021-01-29	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211648 / 002	SCIEGEN PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2021-05-21	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214656 / 002	RUBICON RESEARCH LTD	FINAL_APPROVAL · FINAL_APPROVED	2022-01-13	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214076 / 002	TRIS PHARMA INC	FINAL_APPROVAL · FINAL_APPROVED	2022-01-26	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
213062 / 002	WES PHARMA INC	FINAL_APPROVAL · FINAL_APPROVED	2022-06-06	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211665 / 001	STRIDES PHARMA GLOBAL PTE LTD	FINAL_APPROVAL · FINAL_APPROVED	2022-11-17	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214892 / 002	ADAPTIS PHARMA PRIVATE LTD	FINAL_APPROVAL · FINAL_APPROVED	2022-12-30	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
216156 / 002	AJENAT PHARMACEUTICALS LLC	FINAL_APPROVAL · FINAL_APPROVED	2023-03-07	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211992 / 002	ASCENT PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2025-04-09	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
218733 / 002	MACLEODS PHARMACEUTICALS LTD	FINAL_APPROVAL · FINAL_APPROVED	2025-09-10	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
216536 / 002	AUROBINDO PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2025-11-20	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
215716 / 002	QUAGEN PHARMACEUTICALS LLC	FINAL_APPROVAL · FINAL_APPROVED	2025-12-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
GENERIC	2018-07-19	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.