Product profile · United States

MOUNJARO KWIKPEN

· Patent Litigation & Settlement History ↓

IngredientTIRZEPATIDE

Application typeNDA

Application215866

Product023

Dosage formSOLUTION

RouteSUBCUTANEOUS

Strength50MG/2.4ML (20.8MG/ML)

Approval date2026-01-20

Marketing statusPrescription

Status event—

ApplicantELI LILLY AND CO

Product source

Current GenericRadar decision

Year2036

SelectionDEEP_REVIEW

ReviewFINAL

Anchor typeTRUE_DS_PATENT

Anchor date2036-05-13

Patent anchor2036-05-13

Exclusivity anchor2027-05-13

Protection date2041-12-30

First Final ANDA—

Status event—

US12616740 independent1/6/11/16 and all20 claims plus2026-07-14 correction reviewed. Claim11 does not require5/10/15mg maintenance but requires T2D glycemic-control purpose and2.5mg >=4weeks then5mg escalation. These conditions are not established as necessary for all current approved uses including CV risk reduction. U confirmed; DS-equivalent=N. Retain US9474780 anchor2036-05-13 and2039/2041 tails. Resolve decision flag; no generic-absence assertion.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
9474780	2036-05-13	DS/DP/U U-4374	Y	N	TRUE_DS \| B1C0201 issued-claim review2026-10-14: TRUE_DS	—	—	—
9474780	2036-05-13	ORANGE_BOOK U-4374	Y	N	TRUE_DS English description not available.	—	—	—
12343382	2039-07-22	U U-4400	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	U U-4230	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	U U-4401	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	U U-4231	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	U U-4232	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	U U-4229	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12343382	2039-07-22	ORANGE_BOOK U-4229 / U-4230 / U-4231 / U-4232 / U-4400 / U-4401	N	N	U English description not available.	—	—	—
12616740	2039-07-22	U U-4501	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12616740	2039-07-22	U U-4502	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12616740	2039-07-22	U U-4500	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12616740	2039-07-22	ORANGE_BOOK U-4500 / U-4501 / U-4502	N	N	U English description not available.	—	—	—
12295987	2041-12-30	U U-4193	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12295987	2041-12-30	U U-4192	N	N	U \| B1C0201 issued-claim review2026-10-14: U	—	—	—
12295987	2041-12-30	ORANGE_BOOK U-4192 / U-4193	N	N	U English description not available.	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
NCE	2022-05-13	2027-05-13	English description not available.	Y	Y	2027-05-13	—	Source
NCE	2022-05-13	2027-05-13	English description not available.	Y	Y	2027-05-13		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 (1)

Type	Date	Role	Basis	Source
FULL_YEAR_RECHECK	—	ANCHOR_AND_TAIL	US12616740 independent1/6/11/16 and all20 claims plus2026-07-14 correction reviewed. Claim11 does not require5/10/15mg maintenance but requires T2D glycemic-control purpose and2.5mg >=4weeks then5mg escalation. These conditions are not established as necessary for all current approved uses including CV risk reduction. U confirmed; DS-equivalent=N. Retain US9474780 anchor2036-05-13 and2039/2041 tails. Resolve decision flag; no generic-absence assertion.	Source

Decision history

Current	Year	Status	Review	Anchor	Judged
Y	2036	DEEP_REVIEW	FINAL	2036-05-13	2026-10-17 23:57:57
N	2036	DEEP_REVIEW	FINAL	2036-05-13	2026-10-14 05:05:00

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.