LAMICTAL XR Drug Patent 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-nine suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
DrugPatentWatch® 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 92 |
Patent Applications: | 4,295 |
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 |
---|---|
Brown University | Phase 2 |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
The Searle Company LTD., Pakistan. | Phase 1 |
Pharmacology for LAMICTAL XR
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 XR
Paragraph IV (Patent) Challenges for LAMICTAL XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LAMICTAL XR | Extended-release Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | 022115 | 1 | 2014-02-12 |
US Patents and Regulatory Information for LAMICTAL XR
LAMICTAL XR is protected by two US patents.
Patents protecting LAMICTAL XR
Formulations and method of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Oral dosage form for controlled drug release
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
International Patents for LAMICTAL XR
See the table below for patents covering LAMICTAL XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Morocco | 27509 | FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE | See Plans and Pricing |
Russian Federation | 2325163 | КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН (LAMOTRIGINE-BASED COMPOSITIONS OF PROLONGED RELEASE) | See Plans and Pricing |
Malaysia | 141049 | SUSTAINED RELEASE FORMULATIONS COMPRISING LAMOTRIGINE | See Plans and Pricing |
Mexico | PA04007794 | FORMA DE DOSIFICACION ORAL PARA LA LIBERACION CONTROLADA DE UN FARMACO. (ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE.) | See Plans and Pricing |
Ukraine | 81756 | ОРАЛЬНАЯ ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОНТРОЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА;ОРАЛЬНА ДОЗОВАНА ЛІКАРСЬКА ФОРМА ДЛЯ КОНТРОЛЬОВАНОГО ВИВІЛЬНЕННЯ ЛІКАРСЬКОГО ЗАСОБУ (Normal;heading 1;heading 2;CONTROLLED RELEASE ORAL DOSAGE FORM) | See Plans and Pricing |
Slovenia | 1474114 | See Plans and Pricing | |
Cyprus | 1109119 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |