Viewing data from:

FOUNDAYO

NDA

ORFORGLIPRON CALCIUM | N220934 | ELI LILLY AND CO

6 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

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2038

Today

RE50455

Sep. 26, 2037

NCE

Apr. 1, 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

4 trials from ClinicalTrials.gov — 1 recruiting, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy Discontinuation NCT07729332	Phase 4	Not Yet Recruiting	Massachusetts General Hospital	60	2026-11-01 → 2031-07-31
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin NCT06045221	Phase 3	Completed	Eli Lilly and Company	1,698	2023-09-22 → 2025-08-22
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants NCT06370728	Phase 1	Completed	Eli Lilly and Company	30	2024-05-06 → 2024-07-23
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin NCT06192108	Phase 3	Completed	Eli Lilly and Company	962	2024-01-10 → 2025-09-26

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 6 NDCs

Highest NADAC/Unit

$21.08

per ea

Lowest NADAC/Unit

$20.83

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00002495331FOUNDAYO 17.2 MG TABLET	$21.08	EA	Brand	—	2026-10-21
00002480331FOUNDAYO 9 MG TABLET	$20.92	EA	Brand	—	2026-10-21
00002417831FOUNDAYO 0.8 MG TABLET	$20.92	EA	Brand	—	2026-10-21
00002450331FOUNDAYO 2.5 MG TABLET	$20.89	EA	Brand	—	2026-10-21
00002479431FOUNDAYO 5.5 MG TABLET	$20.88	EA	Brand	—	2026-10-21
00002483931FOUNDAYO 14.5 MG TABLET	$20.83	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

ALLSINO PHARMACEUTICAL CO LTDORFORGLIPRON

DMF 418842025

FUJIAN GENOHOPE BIOTECH LTDORFORGLIPRON

DMF 423932025

NINGXIA LABSCHEM CO LTDORFORGLIPRON

DMF 420122025

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDORFORGLIPRON

DMF 418152025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 2, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — EQ 0.8MG BASE

RLD

1 patent1 exclusivity▴

TABLET;ORAL | Approved: Apr 1, 2026

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE50455	Sep 26, 2037	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NCE	Apr 1, 2031	Active

#002 — EQ 2.5MG BASE

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Apr 1, 2026

#003 — EQ 5.5MG BASE

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Apr 1, 2026

#004 — EQ 9MG BASE

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Apr 1, 2026

#005 — EQ 14.5MG BASE

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Apr 1, 2026

#006 — EQ 17.2MG BASE

RLD

1 patent1 exclusivity▾

TABLET;ORAL | Approved: Apr 1, 2026