DILAUDID-HP Drug Patent Profile
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When do Dilaudid-hp patents expire, and when can generic versions of Dilaudid-hp launch?
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. Seventeen 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.
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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 |
| 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 |
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 and 1 mg/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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | 019034-001 | Jan 11, 1984 | ⤷ Sign Up | ⤷ Sign Up |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >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.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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