Dilaudid-HP Drug Patent Profile
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When do Dilaudid-hp patents expire, and what generic alternatives are available?
Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are two patents protecting this drug and four Paragraph IV challenges.
This drug has twenty-two patent family members in twelve countries.
The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dilaudid-hp
A generic version of Dilaudid-HP was approved as hydromorphone hydrochloride by HIKMA on July 29th, 1998.
Summary for Dilaudid-HP
International Patents: | 22 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 102 |
Patent Applications: | 1,901 |
Formulation / Manufacturing: | see details |
DailyMed Link: | Dilaudid-HP at DailyMed |
Recent Clinical Trials for Dilaudid-HP
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Miami | Phase 2 |
The Cleveland Clinic | N/A |
Hennepin Healthcare Research Institute | Phase 4 |
Pharmacology for Dilaudid-HP
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for Dilaudid-HP
Paragraph IV (Patent) Challenges for DILAUDID-HP
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 | 019034 | 1 | 2022-12-13 |
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 |
US Patents and Regulatory Information for Dilaudid-HP
Dilaudid-HP is protected by two US patents.
Patents protecting Dilaudid-HP
Packaging system for oxygen-sensitive drugs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Drug container
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for Dilaudid-HP
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Dilaudid-HP
See the table below for patents covering Dilaudid-HP around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2376147 | RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER) | ⤷ Try a Trial |
Japan | 4886953 | ⤷ Try a Trial | |
Spain | 2309001 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |