KLOXXADO Drug Patent Profile
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When do Kloxxado patents expire, and what generic alternatives are available?
Kloxxado is a drug marketed by Hikma and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has fourteen patent family members in seven countries.
The generic ingredient in KLOXXADO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kloxxado
A generic version of KLOXXADO was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.
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Summary for KLOXXADO
| International Patents: | 14 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Patent Applications: | 1,704 |
| Drug Prices: | Drug price information for KLOXXADO |
| What excipients (inactive ingredients) are in KLOXXADO? | KLOXXADO excipients list |
| DailyMed Link: | KLOXXADO at DailyMed |
Pharmacology for KLOXXADO
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid Antagonists |
Paragraph IV (Patent) Challenges for KLOXXADO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KLOXXADO | Nasal Spray | naloxone hydrochloride | 8 mg/spray | 212045 | 1 | 2023-03-30 |
US Patents and Regulatory Information for KLOXXADO
KLOXXADO is protected by five US patents and one FDA Regulatory Exclusivity.
Patents protecting KLOXXADO
Liquid naloxone spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
Liquid naloxone spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
Liquid naloxone spray
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
FDA Regulatory Exclusivity protecting KLOXXADO
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
| 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 | |||
| Hikma | KLOXXADO | naloxone hydrochloride | SPRAY;NASAL | 212045-001 | Apr 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Hikma | KLOXXADO | naloxone hydrochloride | SPRAY;NASAL | 212045-001 | Apr 29, 2021 | RX | Yes | Yes | ⤷ 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 KLOXXADO
See the table below for patents covering KLOXXADO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3500261 | PULVÉRISATION DE NALOXONE LIQUIDE (LIQUID NALOXONE SPRAY) | ⤷ Sign Up |
| European Patent Office | 3177146 | AEROSOL SUBLINGUAL DE NALOXONE (SUBLINGUAL NALOXONE SPRAY) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2018034920 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KLOXXADO
| 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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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 verification 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.
ISSN: 2162-2639
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