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Orange Book drug · Brand (NDA)

Dilaudid

Hydromorphone Hydrochloride

RLDNDA 019034 5 strengths Fresenius Kabi USA
Approved
Apr 30, 2009
Strengths
5
Listed patents
2
Applications
3

What does the FDA Orange Book show for Dilaudid?

Dilaudid contains Hydromorphone Hydrochloride and appears in 3 FDA Orange Book applications. NDA 019034 is the lead filing, with 5 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
3; lead NDA 019034

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Fresenius Kabi USA LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
5

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AP

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
2

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0031MG/MLINJECTABLEINJECTIONPrescriptionAP
RLDRS
0042MG/MLINJECTABLEINJECTIONPrescriptionAP
RLDRS
0054MG/MLINJECTABLEINJECTIONPrescriptionAP
RLDRS
0060.2MG/MLINJECTABLEINJECTIONPrescriptionAP
RLDRS
0070.5MG/0.5MLINJECTABLEINJECTIONPrescriptionAP
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Fresenius Kabi USA LLC

The Orange Book identifies this organization as the applicant responsible for NDA 019034.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

5 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AP across rated presentations

An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

2 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 12, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

22 other ANDAs and 4 other NDAs found

13 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 019034 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-019034

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

5 approved presentations · NDA 019034
TE APRLDRS
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    17 yr 6 mo ago

  2. Today

  3. Patent 9731082 expires

    Listed drug product patent expiration.

    in 5 yr 10 mo

  4. Patent 9248229 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayPatent 9731082: 2032-04-23Patent 9731082Patent 9248229: 2034-03-12Patent 9248229
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

HYDROMORPHONE HYDROCHLORIDE

Strength

1MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 019034

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9731082in 5 yr 10 mo
Product
9248229in 7 yr 9 mo
Product

Other FDA applications for Dilaudid

2 additional filings

The FDA has approved 3 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Dilaudid, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 019891Rhodes PharmsDec 07, 19921AAPrescription
NDA 019892Rhodes PharmsNov 09, 20073ABPrescription

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Hydromorphone Hydrochloride family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Dilaudid: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 019034 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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