NALOXONE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Naloxone Hydrochloride, and what generic alternatives are available?
Naloxone Hydrochloride is a drug marketed by Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, 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 sixty-eight NDAs. There are eighteen patents protecting this drug.
The generic ingredient in NALOXONE HYDROCHLORIDE 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 Hydrochloride
A generic version of NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE?
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Summary for NALOXONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 68 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 353 |
| Patent Applications: | 1,704 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in NALOXONE HYDROCHLORIDE? | NALOXONE HYDROCHLORIDE excipients list |
| DailyMed Link: | NALOXONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for NALOXONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 3 |
| Cure Addiction Now | Phase 3 |
| DEKA S.r.l. | Phase 4 |
Pharmacology for NALOXONE HYDROCHLORIDE
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for NALOXONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for NALOXONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KLOXXADO | Nasal Spray | naloxone hydrochloride | 8 mg/spray | 212045 | 1 | 2023-03-30 |
| NARCAN | Nasal Spray | naloxone hydrochloride | 2 mg/spray | 208411 | 1 | 2017-12-28 |
| NARCAN | Nasal Spray | naloxone hydrochloride | 4 mg/spray | 208411 | 1 | 2016-07-15 |
US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 072090-001 | Apr 11, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070257-001 | Jan 7, 1987 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin | NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE | naloxone hydrochloride; pentazocine hydrochloride | TABLET;ORAL | 075735-001 | Jul 11, 2001 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mankind Pharma | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 218404-001 | Feb 29, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Solopak | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 071672-001 | Nov 17, 1987 | 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 |
