APTIOM Drug Patent Profile
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Which patents cover Aptiom, and when can generic versions of Aptiom launch?
Aptiom is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred patent family members in twenty-six countries.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aptiom
A generic version of APTIOM was approved as eslicarbazepine acetate by DR REDDYS on June 29th, 2021.
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Summary for APTIOM
International Patents: | 100 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 3 |
Patent Applications: | 226 |
Drug Prices: | Drug price information for APTIOM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APTIOM |
What excipients (inactive ingredients) are in APTIOM? | APTIOM excipients list |
DailyMed Link: | APTIOM at DailyMed |
Recent Clinical Trials for APTIOM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sunovion | Phase 3 |
Sunovion | Phase 4 |
Stanford University | Phase 4 |
Pharmacology for APTIOM
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for APTIOM
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 APTIOM
APTIOM is protected by fifteen US patents.
Patents protecting APTIOM
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Pharmaceutical composition comprising licarbazepine acetate
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Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES
Pharmaceutical composition comprising licarbazepine acetate
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Asymmetric catalytic reduction of oxcarbazepine
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Pharmaceutical composition comprising licarbazepine acetate
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Asymmetric catalytic reduction of oxcarbazepine
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Treatments involving eslicarbazepine acetate or eslicarbazepine
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Treatments involving eslicarbazepine acetate or eslicarbazepine
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES
Therapeutical uses of eslicarbazepine
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Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY WHO HAVE BEEN PREVIOUSLY TREATED WITH OXCARBAZEPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | AB | RX | Yes | 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 | ||
>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 APTIOM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for APTIOM
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 APTIOM
When does loss-of-exclusivity occur for APTIOM?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5917
Patent: PROCESO DE REDUCCION CATALITICA ASIMETRICA PARA PREPARAR LOS ISOMEROS (S)-(+) Y (R)-(-) DEL COMPUESTO (10,11-DIHIDRO-10-HIDROXI-5-H DIBENZ [B.F] AZEPIN-5-CARBOXAMIDA]
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06273874
Patent: Asymmetric catalytic reduction of oxcarbazepine
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Austria
Patent: 20665
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Brazil
Patent: 0615970
Patent: 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
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 16984
Patent: REDUCTION CATALYTIQUE ASYMETRIQUE D'OXCARBAZEPINE (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1277937
Patent: Asymmetric catalytic reduction of oxcarbazepine
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Cyprus
Patent: 11988
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Denmark
Patent: 15346
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European Patent Office
Patent: 15346
Patent: REDUCTION CATALYTIQUE ASYMETRIQUE D'OXCARBAZEPINE (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE)
Estimated Expiration: ⤷ Sign Up
Patent: 19836
Patent: Reduction catalytique asymetrique d'oxcarbazepine (Asymmetric catalytic reduction of oxcarbazepine)
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Japan
Patent: 95765
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Patent: 09502893
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Patent: 13173764
Patent: ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE
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Mexico
Patent: 08001291
Patent: REDUCCION CATALITICA ASIMETRICA DE OXCARBAZEPINA. (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5462
Patent: Asymmetric catalytic reduction of oxcarbazepine
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Poland
Patent: 15346
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Portugal
Patent: 3467
Patent: REDUÇÃO CATALÍTICA ASSIMÉTRICA
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Russian Federation
Patent: 39060
Patent: АСИММЕТРИЧЕСКОЕ КАТАЛИТИЧЕСКОЕ ВОССТАНОВЛЕНИЕ ОКСКАРБАЗЕПИНА (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE)
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Patent: 08107718
Patent: АСИММЕТРИЧЕСКОЕ КАТАЛИТИЧЕСКОЕ ВОССТАНОВЛЕНИЕ ОКСКАРБАЗЕПИНА
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Slovenia
Patent: 15346
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South Africa
Patent: 0800986
Patent: Asymmetric catalytic reduction of oxcarbazepine
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South Korea
Patent: 1362281
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Patent: 080036212
Patent: ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE
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Spain
Patent: 71556
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Patent: 62816
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United Kingdom
Patent: 15690
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering APTIOM around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 173468 | ⤷ Sign Up | |
China | 101277937 | Asymmetric catalytic reduction of oxcarbazepine | ⤷ Sign Up |
Ukraine | 98133 | ТЕРАПЕВТИЧНЕ ЗАСТОСУВАННЯ ЕСЛІКАРБАЗЕПІНУ[ТЕРАПЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ ЭСЛИКАРБАЗЕПИНА (THERAPEUTIC USE OF ESLICARBAZEPINE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APTIOM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0751129 | CA 2009 00023 | Denmark | ⤷ Sign Up | |
0751129 | C300406 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
0751129 | 360 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |