LAMICTAL Drug Patent Profile
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When do Lamictal patents expire, and when can generic versions of Lamictal launch?
Lamictal is a drug marketed by Glaxosmithkline Llc and is included in four NDAs. There is one patent protecting this drug.
The generic ingredient in LAMICTAL 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
A generic version of LAMICTAL 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?
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Summary for LAMICTAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 94 |
| Patent Applications: | 4,289 |
| Drug Prices: | Drug price information for LAMICTAL |
| Drug Sales Revenues: | Drug sales revenues for LAMICTAL |
| What excipients (inactive ingredients) are in LAMICTAL? | LAMICTAL excipients list |
| DailyMed Link: | LAMICTAL at DailyMed |
Recent Clinical Trials for LAMICTAL
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
| 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 |
US Patents and Regulatory Information for LAMICTAL
| 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 | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 CD | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764-004 | Sep 8, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | 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 XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-005 | Apr 14, 2010 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-005 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-003 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-001 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-006 | Dec 27, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LAMICTAL
See the table below for patents covering LAMICTAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | 8048848 | ⤷ Sign Up | |
| New Zealand | 193890 | 3,5-DIAMINO-6-(SUBSTITUTED PHENYL)-1,2,4-TRIAZINES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Finland | 67844 | ⤷ Sign Up | |
| Japan | S6133163 | NOVEL INTERMEDIATE COMPOUND FOR MANUFACTURING TRIAZINE DERIVATIVE | ⤷ Sign Up |
| Germany | 3063084 | ⤷ Sign Up | |
| Zimbabwe | 12980 | SUBSTITUTED AROMATIC COMPOUNDS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LAMICTAL
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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