NICOTROL Drug Patent Profile
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Which patents cover Nicotrol, and when can generic versions of Nicotrol launch?
Nicotrol is a drug marketed by Mcneil Cons, Pfizer, and Pfizer Inc. and is included in three NDAs.
The generic ingredient in NICOTROL is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nicotrol
A generic version of NICOTROL was approved as nicotine by AVEVA on October 20th, 1997.
Summary for NICOTROL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 16 |
| Patent Applications: | 5,316 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NICOTROL |
| What excipients (inactive ingredients) are in NICOTROL? | NICOTROL excipients list |
| DailyMed Link: | NICOTROL at DailyMed |
Recent Clinical Trials for NICOTROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Drug Abuse (NIDA) | Early Phase 1 |
| National Institute of Mental Health (NIMH) | Phase 2 |
| Duke University | Early Phase 1 |
Pharmacology for NICOTROL
| Drug Class | Cholinergic Nicotinic Agonist |
Anatomical Therapeutic Chemical (ATC) Classes for NICOTROL
US Patents and Regulatory Information for NICOTROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mcneil Cons | NICOTROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020536-001 | Jul 3, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | NICOTROL | nicotine | INHALANT;ORAL | 020714-001 | May 2, 1997 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer Inc | NICOTROL | nicotine | SPRAY, METERED;NASAL | 020385-001 | Mar 22, 1996 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for NICOTROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mcneil Cons | NICOTROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020536-001 | Jul 3, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | NICOTROL | nicotine | INHALANT;ORAL | 020714-001 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | NICOTROL | nicotine | INHALANT;ORAL | 020714-001 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mcneil Cons | NICOTROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020536-001 | Jul 3, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | NICOTROL | nicotine | INHALANT;ORAL | 020714-001 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | NICOTROL | nicotine | INHALANT;ORAL | 020714-001 | May 2, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NICOTROL
See the table below for patents covering NICOTROL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1059649 | ⤷ Try a Trial | |
| Brazil | 8602341 | ⤷ Try a Trial | |
| Germany | 3685687 | ⤷ Try a Trial | |
| New Zealand | 238285 | NICOTINE INHALER CARTRIDGE: NICOTINE RESERVOIR WITH PENETRABLE SEAL | ⤷ Try a Trial |
| Japan | 2701951 | ⤷ Try a Trial | |
| Israel | 98386 | Nicotine-impermeable container for nicotine inhaler and method of fabricating the same | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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