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Serving leading biopharmaceutical companies globally:

Argus Health
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Daiichi Sankyo
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Generated: December 15, 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 patent protection?

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-two 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
Actavis Labs Ny IncNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL076568-002Jul 29, 2004OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Ny IncNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL079038-001Jul 8, 2009OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
L Perrigo CoNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL076779-001Sep 16, 2004OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Ny IncNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL204794-001May 10, 2016OTCNoNo► 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;BUCCAL078325-001Oct 30, 2006OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glaxosmithkline ConsNICORETTEnicotine polacrilexTROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Actavis Labs Ny IncNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL076569-001Jul 29, 2004OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
GlaxosmithklineNICORETTEnicotine polacrilexGUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
L Perrigo CoNICOTINE POLACRILEXnicotine polacrilexGUM, CHEWING;BUCCAL076789-001Sep 16, 2004OTCNoNo► 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
Denmark1888042► Subscribe
China101222915► Subscribe
European Patent Office1888042► Subscribe
European Patent Office2285411► Subscribe
BrazilPI0911847► Subscribe
Hong Kong1197195► Subscribe
Taiwan200719915► Subscribe
South Africa200710905► Subscribe
Russian Federation2458692► Subscribe
Canada2723011► 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:

Cipla
Daiichi Sankyo
Merck
Chubb
AstraZeneca
Covington
Farmers Insurance
Mallinckrodt
Johnson and Johnson
Chinese Patent Office

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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