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, and Rising. and is included in seventeen NDAs.
The generic ingredient in NALBUPHINE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Four 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.
Summary for NALBUPHINE
US Patents: | 0 |
Applicants: | 7 |
NDAs: | 17 |
Raw Ingredient (Bulk) Api Vendors: | 17 |
Clinical Trials: | 103 |
Patent Applications: | 4,470 |
Formulation / Manufacturing: | see details |
DailyMed Link: | NALBUPHINE at DailyMed |
Recent Clinical Trials for NALBUPHINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Early Phase 1 |
Sinew Pharma Inc. | Phase 2 |
Li-Jen Hsin | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for NALBUPHINE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rising | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 207595-001 | Jan 11, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hospira | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 070914-001 | Feb 3, 1989 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |