Dilaudid-HP Generic: When Will Generic Hydromorphone Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Dilaudid-HP Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? August 1995 3 companies approved
- When does the last patent end? March 2034 2 patents listed with the FDA
- Can you buy a generic today? Yes 4 companies list one
It already is. A generic hydromorphone hydrochloride is listed for sale by 4 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Dilaudid-HP, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Dilaudid-HP by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 1984 January 1984 FDA Orange Book
- Patents listed 2 last runs to March 2034 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved August 1995 FDA Orange Book
Dilaudid-HP’s Road to a Generic
Dilaudid-HP has had the market to itself since the FDA approved it in January 1984 (Fresenius Kabi USA LLC). Its 2 listed patents run to March 2034. Generic companies have challenged its patents with the FDA since June 2011.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Dilaudid-HP Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Dilaudid-HP’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,731,082 | The product’s formulation | April 2032 | Active |
| 9,248,229 | The product’s formulation | March 2034 | Active |
Source: FDA Orange Book, application 019034. Patent numbers open the patent on Google Patents.
Patent Challenges to Dilaudid-HP
The first patent challenge to Dilaudid-HP reached the FDA in June 2011, from one company on that first day. The FDA’s list has 4 entries for Dilaudid-HP, by form and strength. A first challenger began selling its generic in October 2018.
What Is a Patent Challenge?
A generic company that wants to sell its version before Dilaudid-HP’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Injection, 2 mg/mL | June 2011 | 1 company | Decision deferred decided January 2024 | April 2018 | October 2018 | November 2020 |
| Injection, 10 mg/mL | November 2011 | 1 company | Head start no longer applies decided June 2020 | Not yet | Not yet | Not given |
| Injection, 0.5 mg/0.5 mL and 1 mg/mL | December 2022 | 1 company | First challenger eligible decided June 2024 | February 2024 | May 2024 earliest strength | March 2034 |
| Injection, 0.2 mg/mL | December 2023 | 1 company | First challenger eligible decided June 2024 | February 2024 | October 2024 | March 2034 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Hydromorphone Hydrochloride
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Dilaudid-HP, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Generic companies have challenged Dilaudid-HP’s patents with the FDA since June 2011: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in August 1995. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic hydromorphone hydrochloride is listed for sale by 4 companies. Ask your pharmacy whether it can fill your prescription with it.
Akorn, Hikma Pharmaceuticals USA Inc., Hospira, Inc. and Teva Parenteral Medicines, Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hospira Inc | June 1997 | 10MG/ML | AP |
| Rising Pharma Holdings Inc | April 2010 | 10MG/ML | AP |
| Hikma Pharmaceuticals USA Inc | April 2018 | 0.2MG/ML, 0.5MG/0.5ML, 1MG/ML, 2MG/ML | AP |
| Watson Laboratories Inc discontinued | August 1995 | 10MG/ML | – |
| Barr Laboratories Inc discontinued | April 2003 | 10MG/ML | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Dilaudid-HP Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Dilaudid-HP, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
Dilaudid-HP Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG/ML | Injectable | Injection | January 1984 | Prescription reference product |
| 250MG/VIAL | Injectable | Injection | August 1994 | Discontinued |
Source: FDA Orange Book, Fresenius Kabi USA LLC.
What a Generic Dilaudid-HP Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Dilaudid-HP
Is there a generic for Dilaudid-HP right now?
Yes. The FDA NDC Directory lists a generic hydromorphone hydrochloride from 4 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Dilaudid-HP go generic?
It already has. The FDA NDC Directory lists a generic hydromorphone hydrochloride from 4 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic hydromorphone hydrochloride be the same as Dilaudid-HP?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Dilaudid-HP?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in August 1995: Hospira Inc, Rising Pharma Holdings Inc and Hikma Pharmaceuticals USA Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Dilaudid-HP patent expire?
The FDA Orange Book lists 2 patents for Dilaudid-HP; the last runs to March 2034. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
Has anyone challenged the Dilaudid-HP patents?
Yes. The first patent challenge to Dilaudid-HP reached the FDA in June 2011, from one company on that first day. A first challenger began selling its generic in October 2018. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Tirosint-SolLevothyroxine Sodium2026 to 2027
- Lo Loestrin FeEthinyl Estradiol and Norethindrone AcetateJanuary to March 2029
- BrixadiBuprenorphineJuly 2032
- PoslumaFlotufolastat F 18November 2038
- YorvipathPalopegteriparatide2039 to 2040
- Flonase Sensimist Allergy ReliefFluticasone FuroateTBD no date yet
About Dilaudid-HP
- Generic name hydromorphone hydrochloride
- How it is taken Injection into a muscle or into a vein (IV) or injection under the skin
- Company Fresenius Kabi USA LLC
- Patent challenges Since June 2011 (FDA)
- More drugs Brand-name drugs starting with D
- Have a question? A pharmacist answers, free. Ask about Dilaudid-HP
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.