NALBUPHINE Drug Patent Profile
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Which patents cover Nalbuphine, and what generic alternatives are available?
Nalbuphine is a drug marketed by Abraxis Pharm, Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc. and is included in nineteen NDAs.
The generic ingredient in NALBUPHINE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nalbuphine
A generic version of NALBUPHINE was approved as nalbuphine hydrochloride by HOSPIRA on February 3rd, 1989.
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Summary for NALBUPHINE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 109 |
| Patent Applications: | 4,470 |
| DailyMed Link: | NALBUPHINE at DailyMed |
Recent Clinical Trials for NALBUPHINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yongtao Sun | Phase 4 |
| Kasr El Aini Hospital | N/A |
| Chulalongkorn University | N/A |
US Patents and Regulatory Information for NALBUPHINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abraxis Pharm | NALBUPHINE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 070751-001 | Jul 2, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 207595-001 | Jan 11, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Somerset Theraps Llc | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 216050-002 | Sep 19, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 070914-001 | Feb 3, 1989 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 020200-001 | Mar 12, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Igi Labs Inc | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 072071-001 | Apr 10, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 207595-002 | Jan 11, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
