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DEMEROL

NDA

MEPERIDINE HYDROCHLORIDE | N005010 | QUAGEN PHARMACEUTICALS LLC

7 strengths0 unique patents0 unique exclusivities

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

Medicare Part D Spending

CMS annual spending data for Demerol (2023)

Total Spending

$71K

Total Claims

187

Beneficiaries

Avg Cost/Unit

$7.90

Spending Trend

$63K(2019)→$45K(2020)→$44K(2021)→$58K(2022)→$71K(2023)

YoY Change:+11.6%

5yr CAGR:+17.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PENICK CORPInactiveMEPERIDINE HYDROCHLORIDE

DMF 80781989

MALLINCKRODT INCInactiveMEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML

DMF 116361995

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -63	View Letter (PDF)
Dec 29, 2025	SUPPL -62	View Letter (PDF)
Nov 4, 2024	SUPPL -61	View Letter (PDF)
Mar 5, 2021	SUPPL -59	View Letter (PDF)
Oct 8, 2019	SUPPL -58	View Letter (PDF)
Sep 28, 2018	SUPPL -56	View Letter (PDF)
Sep 28, 2018	SUPPL -57	View Letter (PDF)
Aug 29, 2017	SUPPL -55	View Letter (PDF)
Dec 19, 2016	SUPPL -54	View Letter (PDF)
Nov 2, 2011	SUPPL -51	View Letter (PDF)
Apr 13, 2011	SUPPL -50	View Letter (PDF)
Mar 10, 2009	SUPPL -49	View Letter (PDF)
Jun 8, 2003	SUPPL -48	View Letter (PDF)
Mar 10, 2003	SUPPL -47	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 100MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#005 — 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

#007 — 25MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#009 — 75MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982