Hydromorphone hydrochloride - Generic Drug Details

What are the generic drug sources for hydromorphone hydrochloride and what is the scope of freedom to operate?

Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Fresenius Kabi Usa, Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, Genus, Specgx Llc, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Mpp Pharma, and Nesher Pharms, and is included in twenty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydromorphone hydrochloride has twenty-two patent family members in twelve countries.

There are nine drug master file entries for hydromorphone hydrochloride. Fifteen suppliers are listed for this compound.

Summary for hydromorphone hydrochloride

International Patents:	22
US Patents:	2
Tradenames:	5
Applicants:	18
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	331
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydromorphone hydrochloride
What excipients (inactive ingredients) are in hydromorphone hydrochloride?	hydromorphone hydrochloride excipients list
DailyMed Link:	hydromorphone hydrochloride at DailyMed

Recent Clinical Trials for hydromorphone hydrochloride

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

Sponsor	Phase
Emory University	PHASE3
The Cleveland Clinic	PHASE4
Beth Israel Deaconess Medical Center	PHASE2

See all hydromorphone hydrochloride clinical trials

Pharmacology for hydromorphone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for hydromorphone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.2 mg/mL	019034	1	2023-12-19
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.5 mg/0.5 mL and 1 mg/mL	019034	1	2022-12-13
DILAUDID	Tablets	hydromorphone hydrochloride	2 mg, 4 mg, and 8 mg	019892	1	2013-08-05
DILAUDID-HP	Injection	hydromorphone hydrochloride	10 mg/mL	019034	1	2011-11-04
DILAUDID-HP	Injection	hydromorphone hydrochloride	2 mg/mL	019034	1	2011-06-22
DILAUDID	Oral Solution	hydromorphone hydrochloride	5 mg/5mL	019891	1	2011-02-25
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	8 mg and 12 mg	021217	1	2010-09-02
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	16 mg	021217	1	2010-08-02

US Patents and Regulatory Information for hydromorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Fl Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202144-001	May 12, 2014		DISCN	No	No
Ascent Pharms Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	210506-002	Jan 17, 2018	AB	RX	No	No
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes	9,731,082		Y

Expired US Patents for hydromorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	5,958,452
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	6,706,281
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010	5,702,725

International Patents for hydromorphone hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968729	SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Spain	2693123
Japan	5737692

Market dynamics and financial trajectory for Hydromorphone Hydrochloride

Last updated: April 24, 2026

Hydromorphone hydrochloride is a long-established, branded-to-generic opioid analgesic with mature global demand and pricing that typically shifts from branded premium to lower generic realizations. Financial trajectory is driven by (1) opioid supply and demand controls, (2) settlement-linked enforcement and formulary dynamics in the US, (3) persistent substitution across immediate-release (IR) and extended-release (ER) formats, and (4) state-by-state prescribing restrictions that affect total units and payer mix. The market is also shaped by product stewardship obligations and risk-management policies that influence channel behavior, tender participation, and inventory cycles.

What is the product scope and where does it compete?

Hydromorphone hydrochloride is used for moderate-to-severe pain and is sold in multiple oral formulations, including IR and ER products, with brand history in the US and widespread generic penetration. Competitive pressure varies by formulation and by regulatory posture in each geography.

Typical competitive set by format

• Immediate-release (IR) hydromorphone: competes with other short-acting opioids (various strengths, immediate onset profiles) and with generic conversions that compress net pricing.
• Extended-release (ER) hydromorphone: competes with other ER opioids and is more sensitive to payer controls, prior authorization requirements, and opioid stewardship policies.
• Alternative delivery lines: in practice, market share can be influenced by substitution among opioid classes even when the active ingredient is constant, because prescribers adjust regimen based on formulary rules and patient risk controls.

Where the revenue is usually made

• US remains the largest revenue contributor for most opioid analgesics given population size and formulary intensity.
• EU and UK participate through mature generic markets and national prescribing guidance.
• Canada, Australia, and other developed markets show similar patterns: stable volume with price pressure and policy-driven access controls.

How do policy and enforcement dynamics affect unit demand?

Hydromorphone sits inside a category that faces persistent regulatory and payer scrutiny. Even when total pain demand exists, access and prescribing controls can shift units between opioid products and across time.

Demand-side drivers

• US prescribing controls: state and payer policies restrict opioid initiation, impose quantity limits, and increase prior authorization for certain strengths and ER products. These policies tend to cap growth and can reduce total new starts.
• Manufacturing and distribution compliance: opioid products require tighter controls on inventory flows. Periods of heightened compliance attention can create short-lived supply tightness, which lifts unit prices temporarily but can also reduce channel replenishment.
• Litigation and settlement effects: opioid litigation has influenced payer contracting behavior, wholesaler terms, and brand-generic competitiveness. While these do not eliminate hydromorphone demand, they change financial outcomes through negotiated pricing and channel leverage.

Payer mix

• Commercial: higher sensitivity to prior authorization and formulary tiering, which affects share and net price realization.
• Government: volume can remain steady, but reimbursement rules and utilization management can still compress revenue per script.

What do pricing and margin compression signals look like?

For an established molecule like hydromorphone hydrochloride, market economics typically evolve in a recognizable pattern: branded launch premium fades, then margins compress as generics expand. The financial trajectory is more about net price, contracting cadence, and mix (IR vs ER) than about new chemistry.

Key pricing mechanics

• Genericization: when additional ANDA entries expand, wholesale acquisition cost and net price converge downward. Contracts shift toward lowest net price for the covered formulary.
• ER premium vs IR baseline: ER products often retain a higher net price per mg delivered due to clinical role and payer rules, but ER is also more exposed to utilization restrictions.
• Tender and rebate pressure: large health systems and pharmacy benefit managers negotiate based on total cost of therapy. Generic substitution tends to drive rebate intensity and compress margins.

Margin outlook

• Distribution margins are influenced by supply continuity and contract terms; enforcement cycles can alter inventory velocity.
• Manufacturer margins are driven by realized net pricing, mix of IR/ER, and share of formulary placements. Over time, the profit pool generally shifts from branded suppliers to scale generic manufacturers that can offer aggressive contract pricing while maintaining reliable supply.

How does the competitive landscape shape share and revenue?

Hydromorphone hydrochloride competes in a dense opioid analgesic arena where switching costs are low for payers and moderate for prescribers. The competitive order changes with formulary decisions, safety messaging, and prior authorization rules.

Competitive dynamics

• Formulary listing: once listed, the molecule tends to be a stable option; however, formulary tiering can change annually based on utilization, safety metrics, and budget impact.
• Brand-to-generic shifts: branded products typically lose share as generics gain coverage. Where a branded ER product remains covered at a higher tier, it can hold premium pricing but with narrower upside.
• Therapeutic substitution: prescribers may switch to other opioid actives within the same therapeutic class when access restrictions apply, which reduces growth even if hydromorphone remains available.

What is the market’s financial trajectory by phase (high-level)?

Hydromorphone hydrochloride market financials usually move through three phases.

1) Post-branded premium period (generic expansion)

• Revenue growth slows as generics capture formulary share.
• Net pricing declines as contracts reset.
• Profit pools shift from branded manufacturers to low-cost producers with broad coverage.

2) Mature, policy-controlled steady state

• Unit demand stabilizes with ongoing prescribing restrictions.
• Financial outcomes become mix-driven (IR vs ER, strength mix, channel mix).
• ER markets can show sharper quarter-to-quarter movement due to authorization cycles.

3) Compliance and settlement-adjusted contracting

• Pricing becomes more contract- and tender-driven than list-price-driven.
• Channel inventory management affects short-term revenue timing.
• Manufacturers with stable supply continuity and broad SKU coverage tend to outperform in realized revenue.

What could investors and R&D teams infer from the commercial setup?

Even without molecule-level novelty, hydromorphone hydrochloride can still support business outcomes through operational advantages: reliable supply, competitive contracting, and product-line optimization.

Operational levers that matter financially

• SKU coverage across strengths and IR/ER formats to match prescriber and formulary needs.
• Supply reliability to avoid stockouts that can cause irreversible formulary switching.
• Contracting sophistication: rapid response to PBM and health-system tender requirements, which influences net price realization.
• Risk-management and stewardship capability: compliance readiness can reduce friction in distribution and contracting.

How does patent and exclusivity structure usually influence outcomes?

Hydromorphone hydrochloride is a mature molecule; most value is tied to old exclusivity structures that have largely expired in major markets. The practical outcome for the financial trajectory is that new IP-based upside is limited unless tied to specific formulation IP, lifecycle management, or enforcement-driven periods in niche markets.

Typical pattern for mature opioid actives

• Patent cliffs and generic entry drive step-down in net pricing.
• Any residual premium is often tied to specific brand formulations or packaging, not the active itself.
• Growth generally becomes a function of coverage depth and operational execution rather than IP-led expansion.

Market risks that can shift near-term financial results

The hydromorphone hydrochloride market has risk factors that can move quarterly revenue and margin.

Risk channels

• Regulatory tightening: additional state or payer restrictions reduce new starts or shift patients to alternative therapies.
• Supply chain disruptions: opioid production is sensitive to manufacturing compliance requirements; any disruption can alter volume shipments.
• Contract repricing: PBM and health-system renegotiations can compress realized pricing faster than expected.
• Litigation and enforcement: settlement and enforcement cycles can change procurement terms and channel behavior.

Investment-relevant indicators to track (commercial and financial)

For business decision-making, the following indicators typically correlate with financial trajectory for mature generic opioids.

Commercial indicators

• Formulary placement status and tier changes for IR vs ER hydromorphone.
• PBM coverage breadth across major formularies.
• Generic share movement within hydromorphone class products.

Financial indicators

• Net price per script and per mg trend (not acquisition cost alone).
• Mix shift between IR and ER.
• Volume stability versus utilization management changes.
• Gross-to-net conversion changes tied to rebate and contracting.

What does “financial trajectory” look like in practice?

For hydromorphone hydrochloride, a realistic financial trajectory is usually:

• Limited long-term growth from baseline demand plus replacement prescribing.
• Persistent revenue volatility driven by contract cycles, authorization rules for ER products, and channel inventory timing.
• Net price compression over time with each new generic competitive wave.
• Margin sensitivity to realized net pricing and supply reliability.

A company’s ability to maintain or grow revenue is therefore less dependent on product differentiation and more dependent on execution in contracting and supply continuity.

Key Takeaways

• Hydromorphone hydrochloride is a mature opioid analgesic where financial trajectory is dominated by genericization, formulary access, and policy-driven utilization management rather than new clinical differentiation.
• US policy and payer stewardship drive stabilization in units but constrain growth, especially for ER formulations.
• Revenue is primarily mix- and contract-driven; realized net price and gross-to-net conversion determine margins more than list price.
• Near-term results can swing from inventory timing, contract repricing, and compliance-related supply shifts.

FAQs

1. Is hydromorphone hydrochloride expected to grow faster than the opioid analgesic category?
   Typically no; category growth is constrained by opioid stewardship, and hydromorphone shares tend to be stable with unit caps and substitution effects.

2. Do IR or ER hydromorphone products contribute more to revenue resilience?
   ER often shows sharper payer-driven variability, while IR tends to be more steady; the overall outcome depends on contract coverage and prior authorization intensity.

3. What drives net price changes most for mature hydromorphone?
   PBM and health-system contracting, rebate adjustments, and generic competitive intensity that resets realized pricing.

4. How does generic competition impact the profit pool?
   It compresses net pricing and shifts profits toward producers with scale, reliable supply, and stronger formulary coverage at low cost.

5. What operational capabilities matter most for financial performance?
   Supply continuity, SKU coverage, and contracting speed relative to tender cycles and formulary updates.

References

[1] FDA. “Generic Drugs.” U.S. Food and Drug Administration. (Accessed via FDA Generic Drugs database). https://www.fda.gov/drugs/generic-drugs
[2] U.S. Department of Health and Human Services. “Opioids.” Centers for Medicare & Medicaid Services and related opioid stewardship resources (access via CMS opioid guidance hubs). https://www.cms.gov/ (search: opioids)
[3] CDC. “Guideline for Prescribing Opioids for Chronic Pain.” Centers for Disease Control and Prevention. https://www.cdc.gov/opioids/ (search: prescribing guideline)
[4] Pew Charitable Trusts. “States’ Opioid Policies” and related enforcement/prescribing control summaries. https://www.pewtrusts.org/ (search: opioid policies states)