Naloxone hydrochloride - Generic Drug Details
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What are the generic sources for naloxone hydrochloride and what is the scope of patent protection?
Naloxone hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, 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, Adamis Pharms Corp, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-seven 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. Thirty-two suppliers are listed for this compound.
Summary for naloxone hydrochloride
International Patents: | 245 |
US Patents: | 48 |
Tradenames: | 13 |
Applicants: | 37 |
NDAs: | 87 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 32 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 350 |
Patent Applications: | 2,622 |
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 |
---|---|
DEKA S.r.l. | Phase 4 |
Johns Hopkins University | Phase 4 |
Nirsum Labs | Phase 1 |
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
International Patents for naloxone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 7455157 | ⤷ Try a Trial | |
Japan | 7399887 | ⤷ Try a Trial | |
Canada | 2835940 | FORMES DOSIFIEES PHARMACEUTIQUES INTRANASALES COMPRENANT DE LA NALOXONE (INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE) | ⤷ Try a Trial |
European Patent Office | 2125075 | INJECTEUR MÉDICAL ÉQUIPÉ D'UN SYSTÈME DE DÉTECTION ET DE SURVEILLANCE DE L'OBSERVANCE (MEDICAL INJECTOR WITH COMPLIANCE TRACKING AND MONITORING) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2018034920 | ⤷ Try a Trial | |
United Kingdom | 201105021 | ⤷ Try a Trial | |
Japan | 2014504930 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | 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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