NICOTINE POLACRILEX Drug Patent Profile
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Which patents cover Nicotine Polacrilex, and what generic alternatives are available?
Nicotine Polacrilex is a drug marketed by 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, and Pld Acquisitions. and is included in forty-nine NDAs.
The generic ingredient in NICOTINE POLACRILEX 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 Polacrilex
A generic version of NICOTINE POLACRILEX was approved as nicotine polacrilex by P AND L on March 15th, 1999.
Summary for NICOTINE POLACRILEX
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 49 |
Finished Product Suppliers / Packagers: | 59 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 22 |
Patent Applications: | 6,486 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NICOTINE POLACRILEX |
DailyMed Link: | NICOTINE POLACRILEX at DailyMed |
Recent Clinical Trials for NICOTINE POLACRILEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | Phase 1 |
22nd Century Group, Inc. | Phase 1 |
Vince & Associates Clinical Research, Inc. | Phase 1 |
Pharmacology for NICOTINE POLACRILEX
Drug Class | Cholinergic Nicotinic Agonist |
Anatomical Therapeutic Chemical (ATC) Classes for NICOTINE POLACRILEX
Paragraph IV (Patent) Challenges for NICOTINE POLACRILEX
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 NICOTINE POLACRILEX
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 | 213233-002 | Aug 4, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aurobindo Pharma | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 213266-001 | Aug 3, 2021 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
P And L | NICOTINE POLACRILEX | nicotine polacrilex | TROCHE/LOZENGE;ORAL | 212057-001 | May 14, 2020 | OTC | No | 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 |