Lamotrigine - Generic Drug Details
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What are the generic sources for lamotrigine and what is the scope of freedom to operate?
Lamotrigine
is the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Lamotrigine has forty-four patent family members in thirty countries.
There are thirty-two drug master file entries for lamotrigine. Fifty-two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for lamotrigine
| International Patents: | 44 |
| US Patents: | 1 |
| Tradenames: | 5 |
| Applicants: | 42 |
| NDAs: | 53 |
| Drug Master File Entries: | 32 |
| Finished Product Suppliers / Packagers: | 52 |
| Raw Ingredient (Bulk) Api Vendors: | 150 |
| Clinical Trials: | 209 |
| Patent Applications: | 6,968 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for lamotrigine |
| Drug Sales Revenues: | Drug sales revenues for lamotrigine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lamotrigine |
| What excipients (inactive ingredients) are in lamotrigine? | lamotrigine excipients list |
| DailyMed Link: | lamotrigine at DailyMed |
Recent Clinical Trials for lamotrigine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Westfälische Wilhelms-Universität Münster | Phase 4 |
| Dr. Inge Winter | Phase 4 |
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
Generic filers with tentative approvals for LAMOTRIGINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 200MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 150MG | TABLET;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 100MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for lamotrigine
| 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 LAMOTRIGINE
| 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 |
| LAMICTAL ODT | Orally Disintegrating Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, and 200 mg | 022251 | 1 | 2009-12-21 |
US Patents and Regulatory Information for lamotrigine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 201791-003 | Jan 18, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Labs Inc | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 200828-001 | Jul 15, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 076630-002 | Jan 22, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-004 | Dec 27, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 lamotrigine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-003 | May 29, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-004 | May 29, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline Llc | LAMICTAL | lamotrigine | TABLET;ORAL | 020241-002 | Dec 27, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline Llc | LAMICTAL XR | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115-006 | Jun 21, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lamotrigine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Morocco | 27509 | FORMULATIONS A LIBERATION PROLONGEE CONTENANT DE LA LAMOTRIGINE | ⤷ Try a Trial |
| Poland | 213565 | ⤷ Try a Trial | |
| Germany | 60326590 | ⤷ Try a Trial | |
| Russian Federation | 2325163 | КОМПОЗИЦИИ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, ВКЛЮЧАЮЩИЕ ЛАМОТРИГИН (LAMOTRIGINE-BASED COMPOSITIONS OF PROLONGED RELEASE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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