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 Sunovion Pharms Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and three patent family members in twenty-seven countries.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this compound. One supplier is 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 LABS LTD on June 29th, 2021.
Summary for APTIOM
| International Patents: | 103 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 3 |
| Patent Applications: | 372 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for APTIOM
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 thirteen US patents.
Patents protecting APTIOM
Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Methods of treatment of partial onset seizures using eslicarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Asymmetric catalytic reduction of oxcarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical composition comprising licarbazepine acetate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Asymmetric catalytic reduction of oxcarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES
Treatments involving eslicarbazepine acetate or eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ABSENCE SEIZURES
Therapeutical uses of eslicarbazepine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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 |
|---|---|---|---|---|---|---|---|
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-002 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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
Estimated Expiration: See Plans and Pricing
Australia
Patent: 06273874
Estimated Expiration: See Plans and Pricing
Austria
Patent: 0665
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0615970
Estimated Expiration: See Plans and Pricing
Canada
Patent: 16984
Estimated Expiration: See Plans and Pricing
China
Patent: 1277937
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 11988
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 15346
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 15346
Estimated Expiration: See Plans and Pricing
Patent: 19836
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9062
Estimated Expiration: See Plans and Pricing
Japan
Patent: 95765
Estimated Expiration: See Plans and Pricing
Patent: 09502893
Estimated Expiration: See Plans and Pricing
Patent: 13173764
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 08001291
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 5462
Estimated Expiration: See Plans and Pricing
Poland
Patent: 15346
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 3467
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 39060
Estimated Expiration: See Plans and Pricing
Patent: 08107718
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 15346
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0800986
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1362281
Estimated Expiration: See Plans and Pricing
Patent: 080036212
Estimated Expiration: See Plans and Pricing
Spain
Patent: 71556
Estimated Expiration: See Plans and Pricing
Patent: 62816
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 15690
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| Hungary | E032467 | See Plans and Pricing | |
| Argentina | 003962 | DIHIDRODIBENZO/B,F/AZEPINAS ÚTILES EN EL TRATAMIENTO DE ALGUNOS DESÓRDENES DEL SISTEMA NERVIOSO CENTRAL Y PERÍFERICO, MÉTODO PARA PREPARAR DICHOS COMPUESTOS Y SUS COMPOSICIONES FARMACÉUTICAS,Y, SUS USOS | See Plans and Pricing |
| Croatia | P20161329 | See Plans and Pricing | |
| Netherlands | 300406 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APTIOM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1915346 | C01915346/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: ESLICARBAZEPINACETAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67375 02.04.2020 |
| 0751129 | C300406 | Netherlands | See Plans and Pricing | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
| 0751129 | 09C0040 | France | See Plans and Pricing | PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421 |
| 0751129 | SPC027/2009 | Ireland | See Plans and Pricing | SPC027/2009: 20091119, EXPIRES: 20210627 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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