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NDA

ENLICITIDE DECANOATE | N220848 | MERCK SHARP AND DOHME LLC

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

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Today

11427616

Feb. 4, 2040

NCE

Jul. 15, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov — 3 recruiting, 3 active, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)NCT07776665	Phase 1	Active	Merck Sharp & Dohme LLC	30	2026-08-31 → 2026-12-21
A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)NCT07300280	Phase 1	Active	Merck Sharp & Dohme LLC	60	2025-12-29 → 2026-10-21
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)NCT07216482	Phase 3	Active	Merck Sharp & Dohme LLC	996	2025-11-11 → 2026-11-05
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)NCT07058077	Phase 2/3	Recruiting	Merck Sharp & Dohme LLC	153	2025-08-21 → 2037-01-23
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)NCT07614984	Phase 2	Recruiting	Merck Sharp & Dohme LLC	750	2026-06-30 → 2027-10-12
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)NCT07821944	Phase 3	Recruiting	Merck Sharp & Dohme LLC	150	2026-10-15 → 2027-11-26
A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)NCT07619443	Phase 1	Completed	Merck Sharp & Dohme LLC	30	2026-07-01 → 2026-09-22
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids NCT05952856	Phase 3	Completed	Merck Sharp & Dohme LLC	2,912	2023-08-10 → 2025-07-28
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)NCT05934292	Phase 1	Completed	Merck Sharp & Dohme LLC	33	2023-07-20 → 2024-01-19
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)NCT06643377	Phase 1	Completed	Merck Sharp & Dohme LLC	27	2024-11-22 → 2025-06-25

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 16, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: Jul 15, 2026

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11427616	Feb 4, 2040	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NCE	Jul 15, 2031	Active