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Generated: July 20, 2017
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 Aurobindo Pharma, Dr Reddys Labs Ltd, Taro, Alembic Pharms Ltd, Sandoz, Zydus Pharms Usa Inc, Pharmascience Inc, Glaxosmithkline Llc, Jubilant Generics, Teva, Mylan, Apotex Inc, Taro Pharm Inds, Watson Labs, Impax Labs Inc, Jubilant Cadista, Actavis Elizabeth, Zydus Pharms Usa, Hikma Pharms, Mylan Labs Ltd, Torrent Pharms, Par Pharm, Actavis Totowa, Glenmark Generics, Torrent Pharms Ltd, Unichem Labs Ltd, Anchen Pharms, Sciegen Pharms Inc, Wockhardt, Cipla Ltd, Handa Pharms Llc, Lupin Ltd, Roxane, Alkem Labs Ltd, Wockhardt Ltd, and Glenmark Pharms Ltd, and is included in forty-nine NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 6 |
| Applicants: | 36 |
| NDAs: | 49 |
| Drug Master File Entries: see list | 32 |
| Suppliers / Packagers: see list | 65 |
| Bulk Api Vendors: see list | 75 |
| Clinical Trials: see list | 175 |
| Patent Applications: see list | 6,097 |
| Therapeutic Class: | Bipolar Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | lamotrigine at DailyMed |
| Drug Class | Anti-epileptic Agent Mood Stabilizer Calculi Dissolution Agent Anti-coagulant |
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity Decreased Coagulation Factor Activity |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 25MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 200MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 150MG | TABLET;ORAL |
| 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 Ltd | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202383-005 | Jun 19, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Dr Reddys Labs Ltd | LAMOTRIGINE | lamotrigine | TABLET, CHEWABLE;ORAL | 076701-002 | Jan 22, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Taro Pharm Inds | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078525-002 | Jan 27, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Aurobindo Pharma | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078956-003 | Jan 27, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Impax Labs Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 200828-003 | Jul 15, 2013 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | 5,698,226*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline Llc | LAMICTAL CD | lamotrigine | TABLET, CHEWABLE;ORAL | 020764-004 | Sep 8, 2000 | 4,602,017*PED | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2693072 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4744142 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1072194 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 537885 | ► Subscribe | |||||||||||||||||||||||||||
| Morocco | 27689 | ► 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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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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