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.
The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine 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:
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- What is Average Wholesale Price for NARCAN?
Summary for NARCAN
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 23 |
| Patent Applications: | 3,804 |
| 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 |
|---|---|
| University of New Mexico | PHASE3 |
| Cure Addiction Now | Phase 3 |
| Johns Hopkins University | Phase 3 |
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
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-002 | Jan 24, 2017 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol Myers Squibb | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 071083-001 | Jul 28, 1988 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Emergent | NARCAN | naloxone hydrochloride | SPRAY, METERED;NASAL | 208411-001 | Nov 18, 2015 | OTC | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Adapt | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 016636-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 |
|---|---|---|---|
| Australia | 2015228541 | ⤷ Start Trial | |
| Canada | 2942611 | ⤷ Start Trial | |
| Canada | 2950687 | ⤷ Start Trial | |
| China | 106163499 | ⤷ Start Trial | |
| China | 110755372 | ⤷ Start 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 | ⤷ Start 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 |
DrugChatter Q&A for NARCAN
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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