NARCAN Drug Patent Profile
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Which patents cover Narcan, and what generic alternatives are available?
Narcan is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent. and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has twenty-seven patent family members in fourteen countries.
The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Narcan
A generic version of NARCAN was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.
Summary for NARCAN
International Patents: | 27 |
US Patents: | 2 |
Applicants: | 3 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 20 |
Patent Applications: | 3,753 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NARCAN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NARCAN |
What excipients (inactive ingredients) are in NARCAN? | NARCAN excipients list |
DailyMed Link: | NARCAN at DailyMed |
Recent Clinical Trials for NARCAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Purdue Pharma LP | Phase 4 |
University of Alabama at Birmingham | Phase 4 |
Rush University Medical Center | Early Phase 1 |
Pharmacology for NARCAN
Drug Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NARCAN
Paragraph IV (Patent) Challenges for NARCAN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 NARCAN
NARCAN is protected by two US patents.
Patents protecting NARCAN
Nasal drug products and methods of their use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
Nasal drug products and methods of their use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adapt | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 016636-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-002 | Jan 24, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bristol Myers Squibb | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 071083-001 | Jul 28, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-002 | Jan 24, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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 NARCAN
See the table below for patents covering NARCAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 106163499 | 鼻用药物产品及其使用方法 (Nasal drug products and methods of their use) | ⤷ Try a Trial |
Singapore | 11201607281P | NASAL DRUG PRODUCTS AND METHODS OF THEIR USE | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2017049181 | ⤷ Try a Trial | |
Spain | 2631504 | MEDICAMENTOS DE ADMINISTRACION NASAL Y METODOS PARA SU USO (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NARCAN
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 |