DILAUDID Drug Patent Profile

Which patents cover Dilaudid, and what generic alternatives are available?

Dilaudid is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-two patent family members in twelve countries.

The generic ingredient in DILAUDID is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilaudid

A generic version of DILAUDID was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for DILAUDID

International Patents:	22
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	103
Patent Applications:	5,312
Drug Prices:	Drug price information for DILAUDID
Drug Sales Revenues:	Drug sales revenues for DILAUDID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILAUDID
What excipients (inactive ingredients) are in DILAUDID?	DILAUDID excipients list
DailyMed Link:	DILAUDID at DailyMed

See drug prices for DILAUDID

See drug sales revenues for DILAUDID

Recent Clinical Trials for DILAUDID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Keck School of Medicine of USC	PHASE3
University of Miami	Phase 2
The Cleveland Clinic	N/A

See all DILAUDID clinical trials

Pharmacology for DILAUDID

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for DILAUDID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DILAUDID	Tablets	hydromorphone hydrochloride	2 mg, 4 mg, and 8 mg	019892	1	2013-08-05
DILAUDID	Oral Solution	hydromorphone hydrochloride	5 mg/5mL	019891	1	2011-02-25

US Patents and Regulatory Information for DILAUDID

DILAUDID is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-006	Jan 16, 2020	AP	RX	Yes	Yes	9,248,229		Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No	9,731,082		Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes	9,248,229		Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-007	Feb 10, 2017	AP	RX	Yes	Yes	9,731,082		Y

Expired US Patents for DILAUDID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	SOLUTION;ORAL	019891-001	Dec 7, 1992	6,589,960
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	6,589,960
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-001	Dec 7, 1992	6,589,960

International Patents for DILAUDID

See the table below for patents covering DILAUDID around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2376147
Japan	4886953
Mexico	PA02004678	COMPOSICIONES DE HIDROCODEINONA E HDROMORFINONA Y METODOS PARA SU SINTESIS. (HYDROMORPHINONE AND HYDROCODEINONE COMPOSITIONS AND METHODS FOR THEIR SYNTHESIS.)
Japan	2016512455	酸素感受性薬物用の包装システム

DILAUDID (Hydromorphone): Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is the commercial footprint of DILAUDID?

DILAUDID is the brand name for hydromorphone hydrochloride, an opioid analgesic used for moderate-to-severe pain. In the US, DILAUDID’s commercial trajectory has been shaped by three forces: (1) scheduled opioid contracting and utilization controls, (2) substitution and competitive branded and generic opioid supply, and (3) litigation and compliance-driven restrictions that affect prescribing patterns and pharmacy procurement.

The brand’s market behavior is typically measured through total prescription demand, net price after discounts, and share of voice in opioid formularies. For hydromorphone products, brand performance generally tracks broader opioid policy tightening and the replacement of higher-priced branded products with generics in most non-specialty use-cases.

How has demand trended for hydromorphone brands vs. generics?

Across the opioid class, including hydromorphone, demand typically follows a pattern:

• Early life-cycle (pre-heavy generic share): brand pricing and higher net revenue per script supported by limited AB-rated competition.
• Mature life-cycle (post-generic entry and scale): demand migrates to lower-cost generics as payers tighten formularies and prescribers reduce brand reliance when clinical equivalence is accepted.
• Policy and risk overlay: opioid risk management requirements, stricter prior authorization in some settings, and pharmacy channel scrutiny reduce overall volume growth and can compress pricing power even where absolute demand remains high.

For hydromorphone specifically, generic hydromorphone products occupy most durable demand capture, while branded DILAUDID performance depends on residual brand preference, contract positioning, and patient-level formularies.

What are the key market dynamics that drive DILAUDID pricing and volume?

DILAUDID is exposed to these demand and pricing drivers:

1) Payer contracting and opioid formulary management

• Formularies increasingly apply step edits, prior authorization, and restricted quantities for Schedule II opioids.
• Even where hydromorphone remains clinically preferred, payers steer volume to lowest net-cost options subject to coverage policy.

2) Generic substitution mechanics

• Once multiple AB-rated generic hydromorphone options are available, pharmacy reimbursement and payer net pricing pressure tend to compress brand net sales.
• Brand differentiation is often insufficient to maintain high share without specialty contracting.

3) Supply chain and channel behavior

• Opioids are highly monitored across wholesale and pharmacy channels.
• Procurement controls and auditing requirements can shift ordering patterns across products.

4) Litigation and reputational risk affecting contracting

• Opioid manufacturers and distributors face high scrutiny tied to opioid harms.
• Payer behavior and channel willingness to maintain higher-priced branded inventory can weaken when legal and settlement exposure is prominent across the class.

How has DILAUDID’s financial trajectory typically behaved?

DILAUDID’s financial trajectory in mature markets generally follows a “price compression plus share drift” model:

• Net sales erosion as generics capture more scripts.
• Net price compression driven by payer discounts and pharmacy reimbursement rates.
• Margin pressure as brand spending competes with generic low-cost supply.
• Revenue volatility tied to policy changes and enforcement cycles.

Hydromorphone brands generally do not show sustained growth in mature US markets once generic hydromorphone holds the majority of the addressable prescription base.

What product levers matter most for DILAUDID revenue?

For a hydromorphone brand, revenue is sensitive to:

• Dosage form mix (e.g., immediate-release presentations vs other hydromorphone formats within the broader product set)
• Strength and dosing frequency that drive daily treatment counts
• Institutional contracting (hospital systems and specialty clinics) where formularies can shift in-year
• Patient support programs that can partially offset payer resistance

The financial picture depends on whether DILAUDID maintains any protected use segments (for example, specific institutional contracts or prescriber preference in controlled settings), but in most general markets, the competitive structure favors generics.

Market structure: Where DILAUDID sits in competition

DILAUDID faces direct substitution pressure from:

• Generic hydromorphone hydrochloride products (AB-rated)
• Other immediate-release Schedule II opioids used in similar pain indications (e.g., morphine, oxycodone, fentanyl-based regimens depending on formulation and setting)

In opioid prescribing, interchangeability and payer rules determine whether hydromorphone retains share or is swapped to other lower-cost opioids.

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Financial trajectory view: What should investors model for DILAUDID?

Because DILAUDID is a mature brand under generics pressure, the correct financial model typically focuses on three variables:

1. Total prescriptions for hydromorphone-class opioids (policy-driven demand ceiling)
2. Brand share among eligible scripts (contracting and substitution)
3. Net price after contracting (discounting and reimbursement compression)

A practical base-case assumption for mature opioid brands is:

• volume growth is limited,
• net sales growth is constrained,
• and revenue outcomes tilt toward stability to decline unless a specific contract or restricted-use segment expands.

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Key risks that can change the trajectory

DILAUDID’s financial path can be disrupted by:

• Payer tightening: broader prior authorization or quantity limits reduce shareable scripts.
• Litigation-related contracting changes: if institutional formularies revise preferred suppliers, brand share can drop quickly.
• Regulatory enforcement: increased scrutiny can change prescribing behavior and pharmacy throughput.
• Competitive product realignment: a shift in formulary preference toward another opioid class can cut hydromorphone share.

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Key Takeaways

• DILAUDID (hydromorphone) operates in a mature opioid market where generic substitution and payer formulary controls dominate outcomes.
• The brand’s financial trajectory is typically characterized by net sales erosion and net price compression once generic hydromorphone captures most prescriptions.
• The most decision-relevant drivers to model are brand share among eligible opioid scripts, net price after contracting, and policy-driven limits on opioid prescribing volumes.
• Material deviations from the base-case usually come from contract wins/losses, formulary shifts, or regulatory and litigation-driven channel changes.

FAQs

1) What determines DILAUDID’s net revenue most in mature markets?
Net revenue is primarily driven by net price after discounts and brand share versus AB-rated generics under payer contracting.

2) Does DILAUDID typically grow via demand expansion?
In most mature US settings, demand expansion is limited; financial performance typically depends more on share retention than on market growth.

3) How does payer policy affect hydromorphone prescribing?
Payers can apply step edits, prior authorization, and quantity limits, which reduce eligible scripts and steer volume to lower-cost options.

4) What competition most pressures DILAUDID?
The dominant pressure is generic hydromorphone; secondary pressure comes from other immediate-release opioid substitution permitted by formulary rules.

5) What are the fastest-moving factors for a brand like DILAUDID?
Institutional contracting changes and formulary updates can shift brand share quickly, while policy enforcement can constrain volume over shorter horizons.

References

[1] US Food and Drug Administration (FDA). “Drug Labels (DILAUDID and hydromorphone hydrochloride).” FDA Access Data. https://www.accessdata.fda.gov/