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Serving leading biopharmaceutical companies globally:

UBS
Covington
AstraZeneca
Teva
Novartis
Cerilliant
Johnson and Johnson
Chubb
Argus Health
US Army

Generated: January 20, 2018

DrugPatentWatch Database Preview

Lamotrigine - Generic Drug Details

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What are the generic sources for lamotrigine and what is the scope of lamotrigine patent protection?

Lamotrigine
is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Anchen Pharms, Handa Pharms Llc, Par Pharm, Torrent Pharms Ltd, Wockhardt Ltd, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Apotex Inc, Cipla Ltd, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Wockhardt, and Zydus Pharms Usa, and is included in forty-nine NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamotrigine has one hundred and ten patent family members in thirty-eight countries.

There are thirty-two drug master file entries for lamotrigine. Sixty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.
Tentative approvals for LAMOTRIGINE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe25MGTABLET;ORAL
➤ Subscribe➤ Subscribe200MGTABLET;ORAL
➤ Subscribe➤ Subscribe150MGTABLET;ORAL

US Patents and Regulatory Information for lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc LAMOTRIGINE lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 200828-003 Jul 15, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actavis Totowa LAMOTRIGINE lamotrigine TABLET;ORAL 078669-001 Apr 8, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro Pharm Inds LAMOTRIGINE lamotrigine TABLET;ORAL 078525-001 Jan 27, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-005 Dec 27, 1994 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc LAMOTRIGINE lamotrigine TABLET;ORAL 078625-004 Jan 27, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-004 May 29, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan Labs Ltd LAMOTRIGINE lamotrigine TABLET;ORAL 078443-001 Feb 11, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-001 May 8, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Actavis Elizabeth LAMOTRIGINE lamotrigine TABLET, EXTENDED RELEASE;ORAL 200672-004 Oct 17, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Roxane LAMOTRIGINE lamotrigine TABLET;ORAL 077392-003 Jan 27, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for lamotrigine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-001 Dec 27, 1994 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-003 Aug 24, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-002 Dec 27, 1994 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-003 Dec 27, 1994 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-004 Sep 8, 2000 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-002 Aug 24, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, CHEWABLE;ORAL 020764-001 Aug 24, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for lamotrigine

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
8,647,656 Orally disintegrating tablet compositions of lamotrigine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for lamotrigine

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Serving leading biopharmaceutical companies globally:

Argus Health
Baxter
AstraZeneca
Medtronic
Colorcon
Chubb
Covington
Teva
Express Scripts

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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