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Lamotrigineis the generic ingredient in five branded drugs marketed by Glaxosmithkline Llc, Alembic Pharms Ltd, Aurobindo Pharma, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Atlantide, Par Pharm, Rubicon, Torrent, Zydus Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alkem Labs Ltd, Celltrion, Cipla, Glenmark Generics, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Pharmascience Inc, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa, and is included in fifty-one NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
Lamotrigine has one hundred and thirteen patent family members in thirty-eight countries.
There are thirty-two drug master file entries for lamotrigine. Forty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for lamotrigine
|Drug Master File Entries:||32|
|Suppliers / Packagers:||47|
|Bulk Api Vendors:||129|
|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
|Université de Sherbrooke||Phase 4|
|National Institute on Alcohol Abuse and Alcoholism (NIAAA)||Phase 2|
|Brown University||Phase 2|
Generic filers with tentative approvals for LAMOTRIGINE
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||Mood Stabilizer |
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for LAMOTRIGINE
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Hikma Pharms||LAMOTRIGINE||lamotrigine||TABLET;ORAL||078134-004||Apr 19, 2011||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Atlantide||LAMOTRIGINE||lamotrigine||TABLET, EXTENDED RELEASE;ORAL||202498-003||Jan 4, 2013||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Dr Reddys Labs Ltd||LAMOTRIGINE||lamotrigine||TABLET, EXTENDED RELEASE;ORAL||202383-001||Jun 19, 2013||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Glaxosmithkline Llc||LAMICTAL CD||lamotrigine||TABLET, CHEWABLE;ORAL||020764-001||Aug 24, 1998||Start Trial||Start Trial|
|Glaxosmithkline Llc||LAMICTAL||lamotrigine||TABLET;ORAL||020241-001||Dec 27, 1994||Start Trial||Start Trial|
|Glaxosmithkline Llc||LAMICTAL CD||lamotrigine||TABLET, CHEWABLE;ORAL||020764-003||Aug 24, 1998||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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