Product profile · United States

SUCLEAR

· Patent Litigation & Settlement History ↓

IngredientMAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

Application typeNDA

Application203595

Product001

Dosage formSOLUTION

RouteORAL

Strength1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM

Approval date2013-01-18

Marketing statusDiscontinued

Status event2017-07-21

ApplicantBRAINTREE LABS

Product source

Current GenericRadar decision

Year2017

SelectionWITHDRAWN

ReviewFINAL

Anchor typeFDA_APPROVAL_WITHDRAWAL_EFFECTIVE_DATE

Anchor date2017-07-21

Patent anchor—

Exclusivity anchor2016-01-18

Protection date2016-01-18

First Final ANDA—

Status event2017-07-21

FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2016 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
No patent facts are recorded for this product.

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NC	2013-01-18	2016-01-18	FULL_EXACT_PRODUCT_APPROVED_SCOPE; NC covers the exact two-part bowel-cleansing kit and its sole adult colonoscopy-preparation indication. Approval withdrawal is a separate status fact.	Y	Y	2016-01-18		Source

2026-10-12 · HISTORICAL_RECORDS_RECOVERED · Historical coverage: ANNUALS_2011_2026_REVIEWED

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
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 (2)

Type	Date	Role	Basis	Source
REGULATORY_EXCLUSIVITY	2016-01-18	SCOPE_CONTEXT	FULL_EXACT_PRODUCT_APPROVED_SCOPE; NC covers the exact two-part bowel-cleansing kit and its sole adult colonoscopy-preparation indication. Approval withdrawal is a separate status fact.	Source
REGULATORY_STATUS	2017-07-21	TERMINAL_STATUS	FDA_LEGAL_APPROVAL_WITHDRAWAL; canonical 2016 CANDIDATE; QUALIFYING_ANCHOR_WITH_NO_LATER_RIGHTS. FDA legal approval withdrawal effective date, not notice publication.	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.