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APTIOM Drug Profile
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See Plans and PricingWhen do Aptiom patents expire, and what generic alternatives are available?
Aptiom is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and nineteen patent family members in thirty 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.
US ANDA Litigation and Generic Entry Outlook for Aptiom
Aptiom was eligible for patent challenges on November 8, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 21, 2026. This may change due to patent challenges or generic licensing.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (eslicarbazepine acetate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for APTIOM
| International Patents: | 119 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 3 |
| Patent Applications: | 51 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for APTIOM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for APTIOM |
| DailyMed Link: | APTIOM at DailyMed |
Generic Entry Opportunity Date for APTIOM
Generic Entry Date for APTIOM*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Recent Litigation for APTIOM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bial - Portela & CA S.A. v. SPH Shanghai Zhongxi Pharmaceutical Co., Ltd. | 2018-05-21 |
| BIAL - PORTELA & CA S.A. v. Apotex Inc. | 2018-03-09 |
| BIAL - PORTELA & CA S.A. v. Dr. Reddy's Laboratories, Ltd. | 2018-03-02 |
Pharmacology for APTIOM
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for APTIOM
| (10S)-10-(Acetyloxy)-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide |
| (10S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide |
| (10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate |
| (S)-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide |
| (S)-5-Carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate |
| [(5S)-11-carbamoyl-5,6-dihydrobenzo[b][1]benzazepin-5-yl] acetate |
| 10-Acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide |
| 10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate |
| 236395-14-5 |
| 5H-Dibenz[b,f]azepine-5-carboxamide,10-(acetyloxy)-10,11-dihydro-, (10S)- |
| 5H-Dibenz9b,f)azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10S)- |
| AC1L452K |
| Acetic acid (S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl ester |
| Acetic acid 5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10(S)-yl ester |
| AK163092 |
| AKOS005145781 |
| AN-6410 |
| Aptiom (TN) |
| AS-14058 |
| AX8243774 |
| BDBM50240669 |
| BEA68ZVB2K |
| BIA 2-093 |
| BIA 2-093, >=98% (HPLC), solid |
| BIA 2093 |
| BIA-2-093 |
| CCG-222406 |
| CHEBI:87016 |
| CHEMBL87992 |
| CS-2942 |
| CTK4F1953 |
| D09612 |
| DB09119 |
| DTXSID90178308 |
| E1046 |
| Eslicarbazapine Acetate |
| Eslicarbazepine (acetate) |
| Eslicarbazepine acetate |
| Eslicarbazepine acetate (USAN) |
| Eslicarbazepine acetate [USAN] |
| Exalief |
| exelief |
| FT-0667969 |
| HMS3263M06 |
| HY-B0703 |
| J-015175 |
| J90004 |
| KS-00000QYO |
| LP01102 |
| MolPort-005-942-413 |
| NCGC00165752-01 |
| NCGC00165752-02 |
| NCGC00261787-01 |
| QIALRBLEEWJACW-INIZCTEOSA-N |
| RT-011499 |
| S-(-)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide |
| s4657 |
| SB18907 |
| SCHEMBL250594 |
| SEP - 0002093 |
| Sep 0002093 |
| SEP-0002093 |
| ST24036220 |
| Stedesa |
| Tox21_501102 |
| UNII-BEA68ZVB2K |
| X5819 |
| Zebinix |
| Zebinix (TN) |
| ZINC7295 |
Paragraph IV (Patent) Challenges for APTIOM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| APTIOM | TABLET;ORAL | eslicarbazepine acetate | 022416 | 2017-11-08 |
US Patents and Regulatory Information for APTIOM
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Sunovion Pharms Inc | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for APTIOM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3222323 | Start Trial |
| Spain | 2607002 | Start Trial |
| Germany | 69600985 | Start Trial |
| Australia | 2006273874 | Start Trial |
| Croatia | P20161619 | Start Trial |
| South Korea | 20100093057 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for APTIOM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0751129 | 360 | Finland | Start Trial | |
| 0751129 | CA 2009 00023 | Denmark | Start Trial | |
| 0751129 | SPC/GB09/047 | United Kingdom | Start Trial | 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 |
| 0751129 | 09C0040 | France | Start Trial | 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 | Start Trial | SPC027/2009: 20091119, EXPIRES: 20210627 |
| 0751129 | C300406 | Netherlands | Start Trial | PRODUCT NAME: ESLICARBAZEPINE, DESGEWENST IN; REGISTRATION NO/DATE: EU/1/09/514/001-020 20090421 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
