Nicorette Drug Patent Profile
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When do Nicorette patents expire, and what generic alternatives are available?
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. Fifty-nine 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: | 2 |
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 |
Office of Dietary Supplements (ODS) | Early Phase 1 |
National Center for Complementary and Integrative Health (NCCIH) | 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 | 022360-001 | May 18, 2009 | ⤷ 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 |
>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 |
---|---|---|---|
Hong Kong | 1114767 | 含藥物口香糖的調味 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS) | ⤷ Try a Trial |
European Patent Office | 0497956 | FORMULATIONS DE LIBERATION CONTROLEE (CONTROLLED RELEASE FORMULATIONS) | ⤷ Try a Trial |
New Zealand | 563424 | Flavoring of drug-containing chewing gums | ⤷ Try a Trial |
South Africa | 200710905 | Flavoring of drug-containing chewing gums | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |