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Generated: June 28, 2017
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 Abraxis Pharm, Marsam Pharms Llc, Bristol Myers Squibb, Adapt, Mylan Institutional, Intl Medication, Watson Labs, Hospira, Kaleo Inc, Akorn, Smith And Nephew, Eurohlth Intl Sarl, Solopak, Astrazeneca, Igi Labs Inc, Wyeth Ayerst, West-ward Pharms Int, Purdue Pharma Lp, Sun Pharm Inds Ltd, Sanofi Aventis Us, and Gavis Pharms, and is included in sixty-three NDAs. There are forty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 49 |
| Applicants: | 21 |
| NDAs: | 63 |
| Drug Master File Entries: see list | 12 |
| Suppliers / Packagers: see list | 15 |
| Bulk Api Vendors: see list | 49 |
| Clinical Trials: see list | 2,450 |
| Patent Applications: see list | 6,709 |
| Therapeutic Class: | Antidotes, Deterrents, and Toxicologic Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | naloxone hydrochloride at DailyMed |
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
| 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 | RX | Yes | Yes | 8,231,573 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | RX | Yes | Yes | 8,361,029 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Hospira | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 070256-001 | Jan 7, 1987 | AP | RX | No | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Igi Labs Inc | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 072088-001 | Apr 11, 1989 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Kaleo Inc | EVZIO | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862-001 | Oct 19, 2016 | RX | Yes | Yes | 9,022,022 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,932,252 | Medical injector simulation device | ► Subscribe | |||||||||||||||||||||||||||
| 9,022,980 | Medical injector simulation device | ► Subscribe | |||||||||||||||||||||||||||
| 8,105,281 | Devices, systems and methods for medicament delivery | ► Subscribe | |||||||||||||||||||||||||||
| 8,899,987 | Simulated medicament delivery device having an electronic circuit system | ► Subscribe | |||||||||||||||||||||||||||
| 8,172,082 | Devices, systems and methods for medicament delivery | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 2456245 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101438327 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 227617 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2724069 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 2480407 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 292 | Luxembourg | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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