NALBUPHINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Nalbuphine Hydrochloride, and when can generic versions of Nalbuphine Hydrochloride launch?
Nalbuphine Hydrochloride is a drug marketed by Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc. and is included in seventeen NDAs.
The generic ingredient in NALBUPHINE HYDROCHLORIDE 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 Hydrochloride
A generic version of NALBUPHINE HYDROCHLORIDE was approved as nalbuphine hydrochloride by HOSPIRA on February 3rd, 1989.
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Questions you can ask:
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Summary for NALBUPHINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 17 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 109 |
| Patent Applications: | 660 |
| DailyMed Link: | NALBUPHINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NALBUPHINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yongtao Sun | Phase 4 |
| Kasr El Aini Hospital | N/A |
| Chulalongkorn University | N/A |
Pharmacology for NALBUPHINE HYDROCHLORIDE
| Drug Class | Opioid Agonist/Antagonist |
| Mechanism of Action | Competitive Opioid Antagonists Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for NALBUPHINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for NALBUPHINE HYDROCHLORIDE
US Patents and Regulatory Information for NALBUPHINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 070917-001 | Feb 3, 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 | ||||
| Hospira | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 070916-001 | Feb 3, 1989 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 074471-002 | Mar 19, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Igi Labs Inc | NALBUPHINE HYDROCHLORIDE | nalbuphine hydrochloride | INJECTABLE;INJECTION | 072073-001 | Apr 10, 1989 | 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 |
