Eslicarbazepine acetate - Generic Drug Details
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What are the generic sources for eslicarbazepine acetate and what is the scope of patent protection?
Eslicarbazepine acetate
is the generic ingredient in two branded drugs marketed by Sumitomo Pharma Am, Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, and Torrent, and is included in seven NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Eslicarbazepine acetate has one hundred patent family members in twenty-six countries.
There are twelve drug master file entries for eslicarbazepine acetate. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for eslicarbazepine acetate
International Patents: | 100 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 51 |
Patent Applications: | 433 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eslicarbazepine acetate |
What excipients (inactive ingredients) are in eslicarbazepine acetate? | eslicarbazepine acetate excipients list |
DailyMed Link: | eslicarbazepine acetate at DailyMed |
Recent Clinical Trials for eslicarbazepine acetate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Whanin Pharmaceutical Company | Phase 1 |
Sunovion | Phase 4 |
Stanford University | Phase 4 |
Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 600MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 400MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | 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 eslicarbazepine acetate
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for eslicarbazepine acetate
Paragraph IV (Patent) Challenges for ESLICARBAZEPINE ACETATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
APTIOM | Tablets | eslicarbazepine acetate | 200 mg, 400 mg, 600 mg and 800 mg | 022416 | 7 | 2017-11-08 |
US Patents and Regulatory Information for eslicarbazepine acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys | ESLICARBAZEPINE ACETATE | eslicarbazepine acetate | TABLET;ORAL | 211238-002 | Jun 29, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | 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 eslicarbazepine acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-002 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for eslicarbazepine acetate
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
BIAL - Portela & Ca, S.A. | Zebinix | eslicarbazepine acetate | EMEA/H/C/000988 Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation. |
Authorised | no | no | no | 2009-04-21 | |
BIAL - Portela Ca, S.A. | Exalief | eslicarbazepine acetate | EMEA/H/C/000987 Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. |
Withdrawn | no | no | no | 2009-04-21 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for eslicarbazepine acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | PI0615970 | processo para preparar (s) (+)-10,11-dihidro-10-hidróxi-5h-dibenz/b,f/azepina-5-ca rboxamida, processo para preparar (s)-(-)-10-acetoxi-10,11-dihidro-5h-dibenz/b,f/azepina-5- carboxamida e processo para preparar (r)-(+)-10-acetoxi-10,11-dihidro-5h-dibenz/b,f/azepina-5- carboxamida | ⤷ Sign Up |
Austria | E520665 | ⤷ Sign Up | |
South Korea | 101362281 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for eslicarbazepine acetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0751129 | C300406 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
2214636 | C02214636/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020 |
0751129 | SPC/GB09/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTERED: UK EU/1/09/514/001 20090421; UK EU/1/09/514/002 20090421; UK EU/1/09/514/003 20090421; UK EU/1/09/514/004 20090421; UK EU/1/09/514/005 20090421; UK EU/1/09/514/006 20090421; UK EU/1/09/514/019 20090421; UK EU/1/09/514/020 20090421; UK EU/1/09/514/013 20090421; UK EU/1/09/514/014 20090421; UK EU/1/09/514/015 20090421; UK EU/1/09/514/016 20090421; UK EU/1/09/514/017 20090421; UK EU/1/09/514/018 20090421; UK EU/1/09/514/007 20090421; UK EU/1/09/514/008 20090421; UK EU/1/09/514/009 20090421; UK EU/1/09/514/010 20090421; UK EU/1/09/514/011 20090421; UK EU/1/09/514/012 20090421 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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