NALOXONE Drug Patent Profile
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When do Naloxone patents expire, and what generic alternatives are available?
Naloxone is a drug marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd. and is included in seventy-five NDAs. There are eighteen patents protecting this drug.
The generic ingredient in NALOXONE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naloxone
A generic version of NALOXONE was approved as naloxone hydrochloride; pentazocine hydrochloride by WATSON LABS on January 21st, 1997.
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Questions you can ask:
- What is the 5 year forecast for NALOXONE?
- What are the global sales for NALOXONE?
- What is Average Wholesale Price for NALOXONE?
Summary for NALOXONE
| US Patents: | 0 |
| Applicants: | 31 |
| NDAs: | 75 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 356 |
| Patent Applications: | 4,840 |
| Drug Prices: | Drug price information for NALOXONE |
| What excipients (inactive ingredients) are in NALOXONE? | NALOXONE excipients list |
| DailyMed Link: | NALOXONE at DailyMed |
Recent Clinical Trials for NALOXONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Murdoch Childrens Research Institute | Phase 4 |
| Cure Addiction Now | Phase 3 |
| Johns Hopkins University | Phase 3 |
Pharmacology for NALOXONE
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
US Patents and Regulatory Information for NALOXONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | SPRAY, METERED;NASAL | 217992-001 | Apr 23, 2024 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Igi Labs Inc | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 072083-001 | Apr 11, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070171-001 | Sep 24, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Igi Labs Inc | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 072091-001 | Apr 11, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Labs Ltd | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 213843-001 | Jun 9, 2022 | AP | RX | 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 |
