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-five 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.
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Questions you can ask:
- What is the 5 year forecast for TRILEPTAL?
- What are the global sales for TRILEPTAL?
- What is Average Wholesale Price for TRILEPTAL?
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: | 5,298 |
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 |
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital | Phase 4 |
Collaborative Care Initiative, LLC | Phase 4 |
Pharmacology for TRILEPTAL
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-003 | Jan 14, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 TRILEPTAL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Czech Republic | 9902879 | ⤷ Sign Up | |
Malaysia | 117582 | OXACARBAZEPINE FILM-COATED TABLETS | ⤷ Sign Up |
New Zealand | 336946 | Oxacarbazepine (10,11-dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide) film-coated tablets with median particle size 2-12 um with a max residue of 40 um sieve of up to 5% | ⤷ Sign Up |
Poland | 193332 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |