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

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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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

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$20.66

per ea

Lowest NADAC/Unit

$20.65

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00002417831FOUNDAYO 0.8 MG TABLET	$20.66	EA	Brand	—	2026-06-17
00002450331FOUNDAYO 2.5 MG TABLET	$20.65	EA	Brand	—	2026-06-17
00002479431FOUNDAYO 5.5 MG TABLET	$20.65	EA	Brand	—	2026-06-17

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

API Supply Chain5 active DMFs

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

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDORFORGLIPRON

DMF 418152025

ALLSINO PHARMACEUTICAL CO LTDORFORGLIPRON

DMF 418842025

NINGXIA LABSCHEM CO LTDORFORGLIPRON

DMF 420122025

FUJIAN GENOHOPE BIOTECH LTDORFORGLIPRON

DMF 423932025

EL-PEPTIDO (SHANGHAI) BIOPHARMACEUTICAL CO LTDORFORGLIPRON

DMF 434462026

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