Last updated: February 20, 2026
Dilaudid, the brand name for hydromorphone, is a potent opioid analgesic used to treat severe pain. Multiple manufacturers supply hydromorphone in various formulations worldwide, primarily through licensed pharmaceutical companies. This report identifies core suppliers, their market share, manufacturing locations, and regulatory status.
Major Suppliers of Dilaudid and Hydromorphone
1. Purdue Pharma LP
Profile: Purdue Pharma holds the original patent for Dilaudid in the United States and supplies Dilaudid tablets and injectable forms.
- Manufacturing Sites: United States (Connecticut, New York)
- Regulatory Status: Approved by the FDA; involved in ongoing legal proceedings related to opioid distribution.
- Market Share: Historically dominant in the US; market share dwindled after patent expiration and legal restrictions.
2. Teva Pharmaceutical Industries Ltd.
Profile: One of the largest generic drug manufacturers globally, Teva produces hydromorphone in multiple forms, including tablets and injectables.
- Manufacturing Sites: Israel, United States, and manufacturing facilities globally.
- Regulatory Status: FDA-approved generics for hydromorphone, providing competition to Purdue.
3. Sun Pharmaceuticals Industries Ltd.
Profile: A leading global generic manufacturer, Sun supplies hydromorphone-based products across multiple markets.
- Manufacturing Sites: India, United States.
- Regulatory Status: Approved by the FDA, EMA, and other agencies; supplies both hydromorphone injectables and tablets.
4. Stilpharma (Silan Pharma)
Profile: Produces hydromorphone in several formulations, primarily for international markets.
- Manufacturing Sites: India.
- Regulatory Status: Approved in multiple countries; supplies generic hydromorphone.
5. Others
- Amneal Pharmaceuticals
- MannKind Corporation
- Eon Pharmaceuticals
These companies manufacture hydromorphone generics primarily for regional markets and niche applications.
Regulatory and Market Considerations
| Aspect |
Details |
| Regulatory Agencies |
FDA (US), EMA (Europe), PMDA (Japan), MHRA (UK) |
| Formulations |
Tablets, injectable solutions, concentrated solutions |
| Approval Status |
Patent expired for hydromorphone in multiple regions; generics hold majority market share |
| Market Trends |
Increasing regulation and supply chain scrutiny due to opioid misuse concerns |
Supply Chain Dynamics
The supply chain involves raw opioid raw material production, primarily in India and China, followed by finished product manufacturing in North America, Europe, and Asia. Quality control and regulatory compliance are critical, with recent tightening of controls impacting global supplies.
Key Takeaways
- Purdue Pharma initiated Dilaudid production; now, multiple generic manufacturers supply hydromorphone globally.
- The US market is dominated by generics such as Teva, Sun Pharmaceuticals, and others.
- Manufacturing locations span North America, Europe, and Asia.
- Regulatory approval status varies but generally involves strict oversight by national agencies.
- Supply constraints and regulatory shifts could influence availability and pricing.
FAQs
Q1: Who was the original manufacturer of Dilaudid?
A: Purdue Pharma held the original patent and first marketed Dilaudid.
Q2: Which companies currently produce generic hydromorphone?
A: Teva, Sun Pharmaceuticals, and several regional manufacturers.
Q3: Are there any global shortages of Dilaudid?
A: Supply disturbances have occurred, often due to regulatory scrutiny or manufacturing disruptions, but shortages are typically regional.
Q4: In which formulations is hydromorphone available?
A: Tablets, injectable solutions, and concentrated solutions.
Q5: What are the primary countries regulating hydromorphone sales?
A: The United States (FDA), Europe (EMA), Japan (PMDA), and the UK (MHRA).
References
- Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- Sun Pharmaceutical Industries Ltd. (2022). Product Approvals and Regulatory Filings.
- Teva Pharmaceutical Industries Ltd. Annual Report. (2022).
- Purdue Pharma's legal and regulatory disclosures. (2021).
- European Medicines Agency. (2022). List of medicines authorized in the European Union.
[1] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations
