Nicorette is a drug owned by Haleon Us Holdings Llc. It is protected by 3 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2029. Details of Nicorette's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8501164 | Nicotine lozenge compositions |
Jun, 2029
(4 years from now) | Active |
| US8940772 | Nicotine lozenge composition |
Apr, 2029
(4 years from now) | Active |
| US8323683 | Flavoring of drug-containing chewing gums |
Apr, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nicorette's patents.
Latest Legal Activities on Nicorette's Patents
Given below is the list of recent legal activities going on the following patents of Nicorette.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 May, 2024 | US8323683 |
| Correspondence Address Change Critical | 07 Feb, 2023 | US8323683 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8501164 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 May, 2020 | US8323683 |
| Recordation of Patent Grant Mailed Critical | 06 Aug, 2013 | US8501164 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Aug, 2013 | US8501164 |
| Email Notification Critical | 18 Jul, 2013 | US8501164 |
| Issue Notification Mailed Critical | 17 Jul, 2013 | US8501164 |
| Dispatch to FDC | 28 Jun, 2013 | US8501164 |
| Application Is Considered Ready for Issue Critical | 27 Jun, 2013 | US8501164 |
Several oppositions have been filed on Nicorette's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Nicorette's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nicorette patents.
Nicorette's Oppositions Filed in EPO
Nicorette has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 22, 2015, by Fertin Pharma A/S. This opposition was filed on patent number EP06770085A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06770085A | Apr, 2015 | Fertin Pharma A/S | Revoked |
US patents provide insights into the exclusivity only within the United States, but Nicorette is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nicorette's family patents as well as insights into ongoing legal events on those patents.
Nicorette's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nicorette's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 14, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nicorette Generic API suppliers:
Nicotine Polacrilex is the generic name for the brand Nicorette. 12 different companies have already filed for the generic of Nicorette, with P And L having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nicorette's generic
How can I launch a generic of Nicorette before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nicorette's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nicorette's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Nicorette -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg and 4 mg | 02 Dec, 2015 | 1 | 07 Feb, 2019 | 14 Jun, 2029 | Eligible |
About Nicorette
Nicorette is a drug owned by Haleon Us Holdings Llc. Nicorette uses Nicotine Polacrilex as an active ingredient. Nicorette was launched by Haleon Us Holdings in 2009.
Approval Date:
Nicorette was approved by FDA for market use on 18 May, 2009.
Active Ingredient:
Nicorette uses Nicotine Polacrilex as the active ingredient. Check out other Drugs and Companies using Nicotine Polacrilex ingredient
Dosage:
Nicorette is available in gum, chewing form for buccal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2MG BASE | GUM, CHEWING | Over the counter | BUCCAL |
| EQ 4MG BASE | GUM, CHEWING | Over the counter | BUCCAL |