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Naloxone hydrochloride - Generic Drug Details
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What are the generic sources for naloxone hydrochloride and what is the scope of naloxone hydrochloride freedom to operate?
Naloxone hydrochloride
is the generic ingredient in seven branded drugs marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Purdue Pharma Lp, Gavis Pharms, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in sixty-five NDAs. There are fifty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Naloxone hydrochloride has one hundred and fifty patent family members in seventeen countries.
There are twelve drug master file entries for naloxone hydrochloride. Eighteen suppliers are listed for this compound.
Summary for naloxone hydrochloride
| International Patents: | 150 |
| US Patents: | 53 |
| Tradenames: | 7 |
| Applicants: | 22 |
| NDAs: | 65 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 18 |
| Bulk Api Vendors: | 42 |
| Clinical Trials: | 227 |
| Patent Applications: | 1,284 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | naloxone hydrochloride at DailyMed |
Pharmacology for naloxone hydrochloride
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for naloxone hydrochloride
Synonyms for naloxone hydrochloride
| (-)-N-Allyl-14-hydroxynordihydromorphinone hydrochloride |
| (17R)-17-allyl-3,14-dihydroxy-6-oxo-4,5alpha-epoxymorphinan-17-ium chloride |
| (4R,4AS,7aR,12bS)-3-allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-one hydrochloride |
| (5?)-4,5-Epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one hydrochloride |
| (5|A)-4,5-Epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one Hydrochloride |
| (5a)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride |
| (5alpha,17R)-17-allyl-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium chloride |
| (5alpha)-17-allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-one hydrochloride |
| (5alpha)-17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride |
| (5alpha)-4,5-Epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one hydrochloride |
| 17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one hydrochloride |
| 17-Allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride |
| 17-Allyl-4,5|A-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride |
| 17-Allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride |
| 357-08-4 |
| 357N084 |
| 465-65-6 (Parent) |
| ACN-032222 |
| ACT02626 |
| AK393255 |
| AKOS024418753 |
| Ambap357-08-4 |
| AN-44507 |
| API0006888 |
| CCG-220111 |
| CHEBI:31892 |
| CHEMBL1718 |
| CS-1335 |
| D01340 |
| EINECS 206-611-0 |
| EN 15304 |
| EN-15304 |
| Evzio |
| F850569PQR |
| FT-0082479 |
| H859 |
| HMS1568G04 |
| HY-17417 |
| KS-5379 |
| l-N-Allyl-14-hydroxynordihydromorphinone hydrochloride |
| MCULE-7328605584 |
| MFCD00069322 |
| MLS000069540 |
| Morphinan-6-one, 17-allyl-4,5-alpha-epoxy-3,14-dihydroxy-, hydrochloride |
| Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5alpha)- |
| Nafoxone Hydrochloride |
| nal-oxon hydrochloride |
| Nalonee |
| Naloxone (hydrochloride) |
| Naloxone HCl |
| Naloxone hydrochloride (JP17/USP) |
| Naloxone hydrochloride [USAN:USP:JAN] |
| Naloxonehydrochloride |
| Narcan |
| Narcan (TN) |
| NC00587 |
| NIH 7890 |
| Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, hydrochloride, (-)- |
| Prestwick_879 |
| RGPDIGOSVORSAK-STHHAXOLSA-N |
| s3066 |
| SC-81820 |
| SCHEMBL41390 |
| SMR000058766 |
| SR-01000737374 |
| SR-01000737374-3 |
| UNII-F850569PQR |
| W-106655 |
| W-5064 |
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 | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 205787-001 | Apr 3, 2014 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Smith And Nephew | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 071671-001 | Nov 17, 1987 | DISCN | 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 | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for naloxone hydrochloride
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,084,849 | Medicament delivery devices for administration of a medicament within a prefilled syringe | ➤ Sign Up |
| 9,173,999 | Devices and methods for delivering medicaments from a multi-chamber container | ➤ Sign Up |
| 9,814,838 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone | ➤ Sign Up |
| 7,416,540 | Devices systems and methods for medicament delivery | ➤ Sign Up |
| 7,648,482 | Devices, systems, and methods for medicament delivery | ➤ Sign Up |
| 7,648,483 | Devices, systems and methods for medicament delivery | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for naloxone hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2577517 | ➤ Sign Up |
| Hong Kong | 1126992 | ➤ Sign Up |
| United Kingdom | 2478085 | ➤ Sign Up |
| Japan | 2014510560 | ➤ Sign Up |
| China | 103492019 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2015136373 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for naloxone hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 292 | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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