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LAMICTAL ODT Drug 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. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has eighteen patent family members in thirteen countries.
The generic ingredient in LAMICTAL ODT is lamotrigine. There are thirty-two drug master file entries for this compound. Additional details are available on the lamotrigine profile page.
US ANDA 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
| International Patents: | 18 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 126 |
| Clinical Trials: | 64 |
| Patent Applications: | 2,380 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LAMICTAL ODT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMICTAL ODT |
| DailyMed Link: | LAMICTAL ODT at DailyMed |
See drug prices for LAMICTAL ODT
Recent Clinical Trials for LAMICTAL ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmtechnology LLC | Phase 1 |
| ClinPharmInvest, LLC | Phase 1 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Paragraph IV (Patent) Challenges for LAMICTAL ODT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LAMICTAL ODT | TABLET, ORALLY DISINTEGRATING;ORAL | lamotrigine | 022251 | 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 | Start Trial | Start Trial | Y | Y | Start Trial | |
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-002 | May 8, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-004 | May 8, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL ODT | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251-001 | May 8, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200911267 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009006516 | Start Trial |
| Argentina | 068185 | Start Trial |
| Japan | 5346021 | Start Trial |
| Hong Kong | 1201745 | Start Trial |
| Taiwan | I547282 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
