LAMICTAL ODT Drug Patent Profile
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When do Lamictal Odt patents expire, and when can generic versions of Lamictal Odt launch?
Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lamictal Odt
A generic version of LAMICTAL ODT was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.
Summary for LAMICTAL ODT
Recent Clinical Trials for LAMICTAL ODT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr Cipto Mangunkusumo General Hospital | Phase 4 |
Brown University | Phase 2 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
Pharmacology for LAMICTAL ODT
Drug Class | Anti-epileptic Agent Mood Stabilizer |
Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LAMICTAL ODT
Paragraph IV (Patent) Challenges for LAMICTAL ODT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LAMICTAL ODT | Orally Disintegrating Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, and 200 mg | 022251 | 1 | 2009-12-21 |
US Patents and Regulatory Information for LAMICTAL ODT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-002 | May 8, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-003 | May 8, 2009 | AB | RX | Yes | 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 |
International Patents for LAMICTAL ODT
See the table below for patents covering LAMICTAL ODT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1201745 | 拉莫三嗪的口服崩解片劑組合物 (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE) | ⤷ Try a Trial |
Saudi Arabia | 08290401 | تركيبات أقراص لاموتريجين تتفتت بالفم (Orally Disintegrating Tablet Compositions of Lamotrigine) | ⤷ Try a Trial |
European Patent Office | 2173172 | COMPOSITIONS DE COMPRIMÉ À DÉSINTÉGRATION PAR VOIE ORALE DE LAMOTRIGINE (ORALLY DISINTEGRATING TABLET COMPOSITIONS OF LAMOTRIGINE) | ⤷ Try a Trial |
Argentina | 068185 | COMPOSICIONES DE TABLETAS DE DESINTEGRACION ORAL DE LAMOTRIGINA | ⤷ Try a Trial |
Japan | 2010532384 | ⤷ Try a Trial | |
China | 101801192 | Orally disintegrating tablet compositions of lamotrigine | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |