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-three 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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Questions you can ask:
- What is the 5 year forecast for KLOXXADO?
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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 | |||
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 | ⤷ 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 |
---|---|---|---|
Japan | 2019528278 | 液体ナロキソンスプレー | ⤷ Sign Up |
Canada | 2954370 | AEROSOL SUBLINGUAL DE NALOXONE (SUBLINGUAL NALOXONE SPRAY) | ⤷ Sign Up |
Japan | 2017519803 | 舌下ナロキソンスプレー | ⤷ Sign Up |
Australia | 2017312811 | Liquid naloxone spray | ⤷ Sign Up |
Morocco | 45995 | PULVÉRISATION DE NALOXONE LIQUIDE | ⤷ 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 |