NUBAIN Drug Patent Profile
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When do Nubain patents expire, and when can generic versions of Nubain launch?
Nubain is a drug marketed by Par Pharm Inc and is included in one NDA.
The generic ingredient in NUBAIN 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 Nubain
A generic version of NUBAIN was approved as nalbuphine hydrochloride by HOSPIRA on February 3rd, 1989.
Summary for NUBAIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 23 |
| Clinical Trials: | 6 |
| Patent Applications: | 660 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NUBAIN at DailyMed |
Recent Clinical Trials for NUBAIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Trevi Therapeutics | Phase 1 |
| Syneos Health | Phase 1 |
| Assiut University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for NUBAIN
US Patents and Regulatory Information for NUBAIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm Inc | NUBAIN | nalbuphine hydrochloride | INJECTABLE;INJECTION | 018024-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Par Pharm Inc | NUBAIN | nalbuphine hydrochloride | INJECTABLE;INJECTION | 018024-002 | May 27, 1982 | DISCN | Yes | No | ⤷ 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 |
