Viewing data from:

HYDROMORPHONE HYDROCHLORIDE

ANDA

HYDROMORPHONE HYDROCHLORIDE | A202159 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DILAUDID(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Fresenius Kabi USA, LLC et al v. Eurohealth International Sarl 1:2018cv00835 2 patentsANDA 202159hydromorphone hydrochloride	D. Del.	2018-06-01	Terminated 2018-08-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$2.77

per ml

Lowest NADAC/Unit

$2.77

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00641615125HYDROMORPHONE 2 MG/ML VIAL	$2.77	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$38.19

Highest Price

$38.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00641-6151-25HYDROMORPHONE HCL 2MG/ML INJ	$38.19	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs6 inactive

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

NORAMCO LLCHYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 195612006

SIEGFRIED USA LLCHYDROMORPHONE HYDROCHLORIDE USP

DMF 220822008

SPECGX LLCHYDROMORPHONE HYDROCHLORIDE USP (NP)

DMF 257662012

CHATTEM CHEMICALS INCHYDROMORPHONE HYDROCHLORIDE, USP

DMF 309952016

DIOSYNTH BVInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70111987

TAKEDA PHARMACEUTICAL CO LTDInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 70711987

SPECGX LLCInactiveHYDROMORPHONE HYDROCHLORIDE

DMF 72371987

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 163512002

CODY LABORATORIES INCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 288042014

NORAMCO LLCInactiveHYDROMORPHONE HYDROCHLORIDE USP

DMF 319942020

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 11, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 27, 2018

No patent or exclusivity listings for this strength.