NICOTINE Drug Patent Profile
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When do Nicotine patents expire, and what generic alternatives are available?
Nicotine is a drug marketed by Difgen Pharms, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac. and is included in fifty NDAs.
The generic ingredient in NICOTINE 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 Nicotine
A generic version of NICOTINE was approved as nicotine polacrilex by P AND L on March 15th, 1999.
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Questions you can ask:
- What is the 5 year forecast for NICOTINE?
- What are the global sales for NICOTINE?
- What is Average Wholesale Price for NICOTINE?
Summary for NICOTINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 50 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 941 |
| Patent Applications: | 4,109 |
| Drug Prices: | Drug price information for NICOTINE |
| What excipients (inactive ingredients) are in NICOTINE? | NICOTINE excipients list |
| DailyMed Link: | NICOTINE at DailyMed |
Recent Clinical Trials for NICOTINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Anna Stanhewicz, PhD | Early Phase 1 |
| Multidisciplinary Association for Psychedelic Studies | Early Phase 1 |
| Spaulding Rehabilitation Hospital | Early Phase 1 |
Pharmacology for NICOTINE
| Drug Class | Cholinergic Nicotinic Agonist |
Medical Subject Heading (MeSH) Categories for NICOTINE
Anatomical Therapeutic Chemical (ATC) Classes for NICOTINE
Paragraph IV (Patent) Challenges for NICOTINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NICODERM CQ | Transdermal System | nicotine | 7 mg/24 hrs 14 mg/24 hrs 21 mg/24 hrs | 020165 | 1 | 2014-05-30 |
US Patents and Regulatory Information for NICOTINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 213233-001 | Aug 4, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo R And D | NICOTINE POLACRILEX | nicotine polacrilex | GUM, CHEWING;BUCCAL | 078968-001 | Apr 23, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 210711-001 | Oct 31, 2019 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 212057-002 | May 14, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 208875-001 | Oct 31, 2019 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 210712-001 | Sep 6, 2019 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 209519-002 | Jul 2, 2018 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
