NICORETTE Drug Patent Profile
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When do Nicorette patents expire, and when can generic versions of Nicorette launch?
Nicorette is a drug marketed by Haleon Us Holdings and is included in four NDAs. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in twenty-two countries.
The generic ingredient in NICORETTE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nicorette
A generic version of NICORETTE was approved as nicotine polacrilex by P AND L on March 15th, 1999.
Summary for NICORETTE
International Patents: | 44 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 42 |
Patent Applications: | 4,765 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NICORETTE |
What excipients (inactive ingredients) are in NICORETTE? | NICORETTE excipients list |
DailyMed Link: | NICORETTE at DailyMed |
Recent Clinical Trials for NICORETTE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NYU Langone Health | Phase 1 |
Washington State University | Early Phase 1 |
Office of Dietary Supplements (ODS) | Early Phase 1 |
Pharmacology for NICORETTE
Drug Class | Cholinergic Nicotinic Agonist |
Anatomical Therapeutic Chemical (ATC) Classes for NICORETTE
Paragraph IV (Patent) Challenges for NICORETTE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NICORETTE | Troche/Lozenge (Mini) | nicotine polacrilex | 2 mg and 4 mg | 022360 | 1 | 2015-12-02 |
US Patents and Regulatory Information for NICORETTE
NICORETTE is protected by three US patents.
Patents protecting NICORETTE
Flavoring of drug-containing chewing gums
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nicotine lozenge compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Nicotine lozenge composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Haleon Us Holdings | NICORETTE | nicotine polacrilex | GUM, CHEWING;BUCCAL | 018612-002 | Feb 9, 1996 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 022360-001 | May 18, 2009 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Haleon Us Holdings | NICORETTE | nicotine polacrilex | GUM, CHEWING;BUCCAL | 020066-004 | Sep 25, 2000 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Haleon Us Holdings | NICORETTE (MINT) | nicotine polacrilex | GUM, CHEWING;BUCCAL | 020066-003 | Dec 23, 1998 | OTC | Yes | No | ⤷ 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 NICORETTE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-001 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 022360-002 | May 18, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-002 | Oct 31, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 022360-001 | May 18, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NICORETTE
See the table below for patents covering NICORETTE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2605244 | ⤷ Try a Trial | |
Japan | 5627851 | ⤷ Try a Trial | |
Russian Federation | 2429827 | ПРИДАНИЕ ВКУСА ЖЕВАТЕЛЬНЫМ РЕЗИНКАМ, СОДЕРЖАЩИМ ЛЕКАРСТВЕННОЕ СРЕДСТВО (MEDICATED CHEWING GUM FLAVOURING) | ⤷ Try a Trial |
European Patent Office | 1888042 | AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |