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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Julphar
Fish and Richardson
Mallinckrodt
Federal Trade Commission
Chinese Patent Office
Cantor Fitzgerald
McKesson
Cerilliant

Generated: December 11, 2017

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NICOTINE POLACRILEX - Generic Drug Details

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What are the generic drug sources for nicotine polacrilex and what is the scope of nicotine polacrilex freedom to operate?

Nicotine polacrilex
is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, Watson Labs, Novartis, and Glaxosmithkline Cons, and is included in forty NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicotine polacrilex has forty patent family members in twenty countries.

There are twenty-nine drug master file entries for nicotine polacrilex. Forty-five suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
L Perrigo CoNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL076775-001Sep 16, 2004OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL206393-001Dec 15, 2016OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL206394-001Dec 15, 2016OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexTROCHE/LOZENGE;ORAL077007-002Jan 31, 2006OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Ny IncNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL204833-001Feb 26, 2016OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL078325-001Oct 30, 2006OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineNICORETTEnicotine polacrilexGUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexTROCHE/LOZENGE;ORAL090711-002Jul 10, 2009OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL078967-001Apr 23, 2008OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo R And DNICOTINE POLACRILEXnicotine polacrilexTROCHE/LOZENGE;ORAL090821-001Jul 10, 2009OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nicotine polacrilex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ConsCOMMITnicotine polacrilexTROCHE/LOZENGE;ORAL021330-001Oct 31, 2002► Subscribe► Subscribe
Glaxosmithkline ConsNICORETTEnicotine polacrilexTROCHE/LOZENGE;ORAL022360-002May 18, 2009► Subscribe► Subscribe
Glaxosmithkline ConsNICORETTEnicotine polacrilexTROCHE/LOZENGE;ORAL022360-001May 18, 2009► Subscribe► Subscribe
Glaxosmithkline ConsCOMMITnicotine polacrilexTROCHE/LOZENGE;ORAL021330-002Oct 31, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: nicotine polacrilex

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,658,200Flavoring of drug-containing chewing gums► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: nicotine polacrilex

Country Document Number Estimated Expiration
Japan2015232012► Subscribe
Spain2605244► Subscribe
World Intellectual Property Organization (WIPO)2009134947► Subscribe
European Patent Office2285411► Subscribe
Taiwan200719915► Subscribe
Russian Federation2010149050► Subscribe
Spain2516650► Subscribe
South Africa200710905► Subscribe
Hong Kong1153146► Subscribe
BrazilPI0611520► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Merck
Novartis
Cipla
McKinsey
Fish and Richardson
Healthtrust
Teva
McKesson
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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