NARCAN Drug Patent Profile
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When do Narcan patents expire, 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-six 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.
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Questions you can ask:
- What is the 5 year forecast for NARCAN?
- What are the global sales for NARCAN?
- What is Average Wholesale Price for NARCAN?
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: | 21 |
Patent Applications: | 4,106 |
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 |
![NARCAN drug patent expirations Drug patent expirations by year for NARCAN](/p/graph/s/t/NARCAN-patent-expirations.png)
![Drug Prices for NARCAN](/p/graph/drug-price/NARCAN.png)
Recent Clinical Trials for NARCAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cure Addiction Now | Phase 3 |
Johns Hopkins University | Phase 3 |
Purdue Pharma LP | Phase 4 |
Pharmacology for NARCAN
Drug Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-002 | Jan 24, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Bristol Myers Squibb | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 071083-001 | Jul 28, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-002 | Jan 24, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | 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 NARCAN
See the table below for patents covering NARCAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 11201607281P | NASAL DRUG PRODUCTS AND METHODS OF THEIR USE | ⤷ Sign Up |
Israel | 279001 | תרופות לאף ושיטות שימוש בהן (Nasal drug products and methods of their use) | ⤷ Sign Up |
Mexico | 2018003349 | PRODUCTOS DE FARMACO NASAL Y METODOS DE SU USO. (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE.) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2017049181 | ⤷ Sign Up | |
>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 | ⤷ 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 |