TRILEPTAL Drug Patent Profile
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When do Trileptal patents expire, and what generic alternatives are available?
Trileptal is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in TRILEPTAL is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Trileptal
A generic version of TRILEPTAL was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.
Summary for TRILEPTAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 24 |
| Patent Applications: | 4,883 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRILEPTAL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRILEPTAL |
| What excipients (inactive ingredients) are in TRILEPTAL? | TRILEPTAL excipients list |
| DailyMed Link: | TRILEPTAL at DailyMed |
Recent Clinical Trials for TRILEPTAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
| Collaborative Care Initiative, LLC | Phase 4 |
| Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital | Phase 4 |
Pharmacology for TRILEPTAL
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for TRILEPTAL
Paragraph IV (Patent) Challenges for TRILEPTAL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TRILEPTAL | Oral Suspension | oxcarbazepine | 300 mg/5 mL | 021285 | 1 | 2006-12-26 |
| TRILEPTAL | Tablets | oxcarbazepine | 150 mg, 300 mg and 600 mg | 021014 | 1 | 2006-05-05 |
US Patents and Regulatory Information for TRILEPTAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-003 | Jan 14, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | AB | RX | 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 TRILEPTAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-003 | Jan 14, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRILEPTAL
See the table below for patents covering TRILEPTAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Malaysia | 117582 | OXACARBAZEPINE FILM-COATED TABLETS | ⤷ Try a Trial |
| Turkey | 200201459 | ⤷ Try a Trial | |
| Hungary | 0203782 | ⤷ Try a Trial | |
| Czech Republic | 302737 | Suspenze obsahující oxkarbazepin (Suspension containing oxcarbazepine) | ⤷ 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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