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-three 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.
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Questions you can ask:
- What is the 5 year forecast for LAMICTAL ODT?
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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 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
Brown University | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-002 | May 8, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-003 | May 8, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|
China | 104161733 | Orally disintegrating tablet compositions of lamotrigine | ⤷ Sign Up |
China | 101801192 | Orally disintegrating tablet compositions of lamotrigine | ⤷ Sign Up |
Australia | 2008272871 | Orally disintegrating tablet compositions of lamotrigine | ⤷ Sign Up |
Saudi Arabia | 08290401 | تركيبات أقراص لاموتريجين تتفتت بالفم (Orally Disintegrating Tablet Compositions of Lamotrigine) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |