NALOXONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for naloxone hydrochloride and what is the scope of patent protection?
Naloxone hydrochloride
is the generic ingredient in fourteen branded drugs 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, Adapt, Bristol Myers Squibb, Kaleo Inc, Zmi Pharma, Amneal, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Summit Biosci, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-nine NDAs. There are forty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Naloxone hydrochloride has two hundred and forty-five patent family members in thirty-eight countries.
There are eight drug master file entries for naloxone hydrochloride. Forty-three suppliers are listed for this compound.
Summary for NALOXONE HYDROCHLORIDE
International Patents: | 245 |
US Patents: | 48 |
Tradenames: | 14 |
Applicants: | 40 |
NDAs: | 89 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 356 |
Patent Applications: | 2,496 |
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 |
---|---|
Murdoch Childrens Research Institute | Phase 4 |
Johns Hopkins University | Phase 3 |
Cure Addiction Now | Phase 3 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | KLOXXADO | naloxone hydrochloride | SPRAY;NASAL | 212045-001 | Apr 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
Harm Reduction Therp | RIVIVE | naloxone hydrochloride | SPRAY, METERED;NASAL | 217722-001 | Jul 28, 2023 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Kaleo Inc | EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for NALOXONE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2012508081 | ⤷ Sign Up | |
Mexico | 2007005946 | DISPOSITIVOS, SISTEMAS Y METODOS DE ENTREGA DE MEDICAMENTOS. (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY.) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006083876 | ⤷ Sign Up | |
Japan | 2008520339 | ⤷ Sign Up | |
Japan | 7399887 | ⤷ Sign Up | |
Australia | 2017312811 | Liquid naloxone spray | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1685839 | 92292 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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