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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for NICORETTE?
- What are the global sales for NICORETTE?
- What is Average Wholesale Price for NICORETTE?
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: | 3,742 |
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 |
![NICORETTE drug patent expirations Drug patent expirations by year for NICORETTE](/p/graph/s/t/NICORETTE-patent-expirations.png)
![Drug Prices for NICORETTE](/p/graph/drug-price/NICORETTE.png)
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 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Nicotine lozenge compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Nicotine lozenge composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 022360-002 | May 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-001 | Oct 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 021330-002 | Oct 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Haleon Us Holdings | NICORETTE | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 022360-001 | May 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Denmark | 2285411 | ⤷ Sign Up | |
Australia | 2006247847 | Flavoring of drug-containing chewing gums | ⤷ Sign Up |
European Patent Office | 0497956 | FORMULATIONS DE LIBERATION CONTROLEE (CONTROLLED RELEASE FORMULATIONS) | ⤷ Sign Up |
Denmark | 0497956 | ⤷ Sign Up | |
Japan | 2015232012 | ニコチンロゼンジ組成物 (NICOTINE LOZENGE COMPOSITION) | ⤷ Sign Up |
Chile | 2009001025 | Composicion de pastilla para chupar que comprende: a) un granulo patron con al menos: un agente tampon alcalino, un modificador de la disolucion y una carga, b) un principio activo de nicotina definido extragranular y al menos un agente tampon alcalino; procedimiento de preparacion; util para eliminar o reducir el uso de tabaco. | ⤷ Sign Up |
European Patent Office | 1888042 | AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |