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 is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in thirty countries.
The generic ingredient in LAMICTAL XR 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 Xr
A generic version of LAMICTAL XR 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 XR?
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Summary for LAMICTAL XR
International Patents: | 44 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 150 |
Clinical Trials: | 94 |
Patent Applications: | 4,284 |
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 |
![LAMICTAL XR drug patent expirations Drug patent expirations by year for LAMICTAL XR](/p/graph/s/t/LAMICTAL_XR-patent-expirations.png)
![Drug Prices for LAMICTAL XR](/p/graph/drug-price/LAMICTAL+XR.png)
See drug prices for LAMICTAL XR
![Drug Sales Revenue Trends for LAMICTAL XR](/p/graph/drug-sales-revenues/LAMICTAL+XR.png)
Recent Clinical Trials for LAMICTAL XR
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 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 |
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 one US patents.
Patents protecting LAMICTAL XR
Formulations and method of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-002 | May 29, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-003 | May 29, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-005 | Apr 14, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-006 | Jun 21, 2011 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LAMICTAL XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-001 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-003 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-002 | May 29, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-006 | Jun 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-005 | Apr 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LAMICTAL XR
See the table below for patents covering LAMICTAL XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2336319 | ⤷ Sign Up | |
Ecuador | SP045232 | FORMA DE DOSIFICACIÓN ORAL, PROCEDIMIENTO PARA PREPARARLA Y USO DE UNA BASE DÉBIL FARMACÉUTICAMENTE ACEPTABLE O UNA SAL O SOLVATO FARMACÉUTICAMENTE ACEPTABLE DE LA MISMA PARA PREPARAR DICHA FORMA DE DOSIFICACIÓN ORAL | ⤷ Sign Up |
Russian Federation | 2007143372 | КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН | ⤷ Sign Up |
China | 1681509 | Slow release preparation containing larmotriazine | ⤷ Sign Up |
Japan | 2010159301 | ORAL DOSAGE FORM FOR CONTROLLED DRUG RELEASE | ⤷ Sign Up |
Cyprus | 1109119 | ⤷ Sign Up | |
United Kingdom | 0217493 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |