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LAMICTAL XR Drug Profile
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When do Lamictal Xr patents expire, and when can generic versions of Lamictal Xr launch?
Lamictal Xr is a drug marketed by Glaxosmithkline Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-five patent family members in thirty-eight countries.
The generic ingredient in LAMICTAL XR is lamotrigine. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
US ANDA Litigation and Generic Entry Outlook for Lamictal Xr
A generic version of LAMICTAL XR was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.
Summary for LAMICTAL XR
| International Patents: | 95 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 126 |
| Clinical Trials: | 64 |
| Patent Applications: | 2,381 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LAMICTAL XR |
| Drug Sales Revenues: | Drug sales revenues for LAMICTAL XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMICTAL XR |
| DailyMed Link: | LAMICTAL XR at DailyMed |
See drug prices for LAMICTAL XR
Recent Clinical Trials for LAMICTAL XR
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 |
Pharmacology for LAMICTAL XR
| Drug Class | Mood Stabilizer Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for LAMICTAL XR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LAMICTAL XR | TABLET, EXTENDED RELEASE;ORAL | lamotrigine | 022115 | 2014-02-12 |
US Patents and Regulatory Information for LAMICTAL XR
| 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 XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-001 | May 29, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-002 | May 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-005 | Apr 14, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | AB | RX | Yes | Yes | 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 XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2325163 | Start Trial |
| China | 1655768 | Start Trial |
| Slovenia | 1474114 | Start Trial |
| Spain | 2323268 | Start Trial |
| Malaysia | 141049 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
