Product profile · United States

IYUZEH

· Patent Litigation & Settlement History ↓

IngredientLATANOPROST

Application typeNDA

Application216472

Product001

Dosage formSOLUTION/DROPS

RouteOPHTHALMIC

Strength0.005%

Approval date2022-12-13

Marketing statusPrescription

Status event—

ApplicantTHEA PHARMA

Product source

Current GenericRadar decision

Year2022

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeAPPROVAL_YEAR_FALLBACK

Anchor date2022-12-13

Patent anchor—

Exclusivity anchor—

Protection date2031-07-08

First Final ANDA—

Status event—

Available evidence does not establish a full-scope DS/DS-equivalent or full-coverage exclusivity anchor; approval-year DEEP_REVIEW is proposed. Direct Final-ANDA linkage may change the result.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
8637054	2031-07-08	DP/U U-446	N	N	FIXED_FORMULATION_USE	—	—	—
8637054	2031-07-08	DP/U U-446	N	N	FIXED_FORMULATION_USE Claims 1/3: glaucoma/IOP-lowering treatment with a specific latanoprost solution. Matching indication names alone does not establish full DS-equivalent coverage; N proposed and adopted classification finalized.	—	—	—

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 · CURRENT_SNAPSHOT_NO_RECORD · Historical coverage: NOT_COMPLETE

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
077697 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	—	APOTEX INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
091449 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	—	SANDOZ INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
200925 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	—	J MOLNER HOLDINGS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
201006 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	—	BAUSCH AND LOMB INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
201786 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	—	SOMERSET THERAPEUTICS LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
090887 / 001	FINAL_APPROVAL · FINAL_APPROVED	2011-07-19	—	EPIC PHARMA LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
202077 / 001	FINAL_APPROVAL · FINAL_APPROVED	2013-02-11	—	CARNEGIE PHARMACEUTICALS LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
202442 / 001	FINAL_APPROVAL · FINAL_APPROVED	2016-04-22	—	FDC LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
206519 / 001	FINAL_APPROVAL · FINAL_APPROVED	2019-09-03	—	EUGIA PHARMA SPECIALITIES LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
218257 / 001	FINAL_APPROVAL · FINAL_APPROVED	2024-11-26	—	GLAND PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
219306 / 001	FINAL_APPROVAL · FINAL_APPROVED	2025-04-14	—	MICRO LABS LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
220360 / 001	FINAL_APPROVAL · FINAL_APPROVED	2025-12-17	—	MANKIND PHARMA LTD	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 12 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
077697 / 001	APOTEX INC	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
091449 / 001	SANDOZ INC	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
200925 / 001	J MOLNER HOLDINGS INC	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
201006 / 001	BAUSCH AND LOMB INC	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
201786 / 001	SOMERSET THERAPEUTICS LLC	FINAL_APPROVAL · FINAL_APPROVED	2011-03-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
090887 / 001	EPIC PHARMA LLC	FINAL_APPROVAL · FINAL_APPROVED	2011-07-19	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
202077 / 001	CARNEGIE PHARMACEUTICALS LLC	FINAL_APPROVAL · FINAL_APPROVED	2013-02-11	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
202442 / 001	FDC LTD	FINAL_APPROVAL · FINAL_APPROVED	2016-04-22	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
206519 / 001	EUGIA PHARMA SPECIALITIES LTD	FINAL_APPROVAL · FINAL_APPROVED	2019-09-03	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
218257 / 001	GLAND PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2024-11-26	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
219306 / 001	MICRO LABS LTD	FINAL_APPROVAL · FINAL_APPROVED	2025-04-14	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
220360 / 001	MANKIND PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2025-12-17	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
PATENT	2031-07-08	FTO_TAIL	Claims 1/3: glaucoma/IOP-lowering treatment with a specific latanoprost solution. Matching indication names alone does not establish full DS-equivalent coverage; N proposed and adopted classification finalized.	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.