Product profile · United States

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· Patent Litigation & Settlement History ↓

IngredientTROFINETIDE

Application typeNDA

Application217026

Product001

Dosage formSOLUTION

RouteORAL

Strength200MG/ML

Approval date2023-03-10

Marketing statusPrescription

Status event—

ApplicantACADIA PHARMS INC

Product source

Current GenericRadar decision

Year2032

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeDS_EQUIVALENT_PATENT

Anchor date2032-07-27

Patent anchor2032-07-27

Exclusivity anchor—

Protection date2043-01-12

First Final ANDA—

Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2032. Anchor type: DS_EQUIVALENT_PATENT. Patent anchor: 2032-07-27. Exclusivity anchor: not recorded. Anchor date: 2032-07-27. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
9212204	2032-01-27	U U-3556	—	—	—	—	—	—
9212204	2032-07-27	— —	—	—	—	—	2032-07-27	—
9212204	2032-07-27	ORANGE_BOOK U-3556	N	Y	DS_EQUIVALENT Claim 1: oral aqueous trofinetide treatment of Rett symptoms; both products have the same sole Rett indication and oral aqueous administration.	—	2032-07-27	—
11370755	2040-08-03	DS/DP —	—	—	—	—	—	—
11370755	2041-02-03	— —	—	—	—	—	2041-02-03	—
11370755	2041-02-03	ORANGE_BOOK —	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2041-02-03	—
11827600	2042-07-12	DS/DP/U U-3556	—	—	—	—	—	—
12492167	2042-07-12	DS/DP/U U-3556	—	—	—	—	—	—
11827600	2043-01-12	— —	—	—	—	—	2043-01-12	—
11827600	2043-01-12	ORANGE_BOOK U-3556	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2043-01-12	—
12492167	2043-01-12	— —	—	—	—	—	2043-01-12	—
12492167	2043-01-12	ORANGE_BOOK U-3556	N	N	DP Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	—	2043-01-12	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	—	2028-03-10		—	—	—	—	Source
NCE	—	2028-03-10	Active-moiety exclusivity; whole scope; earlier than adopted patent anchor.	Y	Y	2028-03-10	—	Source
PED	—	2028-09-10		—	—	—	—	Source
PED	—	2028-09-10	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	Source
ODE-425	—	2030-03-10		—	—	—	—	Source
ODE-425	—	2030-03-10	Rett age 2 and older; whole approved indication; earlier than patent anchor.	Y	Y	2030-03-10	—	Source
PED	—	2030-09-10		—	—	—	—	Source
PED	—	2030-09-10	FDA posted date collected; scope not independently certified; preserved as context/tail.	—	—	—	—	Source

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 (5)

Type	Date	Role	Basis	Source
PATENT	2032-07-27	CANONICAL_ANCHOR	Claim 1: oral aqueous trofinetide treatment of Rett symptoms; both products have the same sole Rett indication and oral aqueous administration.	Source
PATENT	2041-02-03	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2043-01-12	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
PATENT	2043-01-12	FTO_TAIL	Composition, salt, polymorph, dispersion or formulation claim; no automatic DS-equivalent promotion.	Source
REGULATORY_STATUS	2032-07-27	CANONICAL_DECISION	English description not available.	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.