Aptiom is a drug owned by Sumitomo Pharma America Inc. It is protected by 12 US drug patents filed from 2013 to 2022. Out of these, 11 drug patents are active and 1 has expired. Aptiom's patents have been open to challenges since 08 November, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2032. Details of Aptiom's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9206135 | Asymmetric catalytic reduction of oxcarbazepine |
Apr, 2026
(1 year, 3 months from now) | Active |
| US5753646 | Substituted dihydrodibenzo/b,f/azepines, method of their preparation, their use in the treatment of some central nervous system disorders, and pharmaceutical compositions containing them |
Jun, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9750747 | Treatments involving eslicarbazepine acetate or eslicarbazepine |
Aug, 2032
(7 years from now) | Active |
| US8372431 | Pharmaceutical composition comprising licarbazepine acetate |
Apr, 2030
(5 years from now) | Active |
| US9566244 | Pharmaceutical composition comprising licarbazepine acetate |
Oct, 2028
(3 years from now) | Active |
| US10912781 | Pharmaceutical composition comprising licarbazepine acetate |
Oct, 2028
(3 years from now) | Active |
| US9763954 | Therapeutical uses of eslicarbazepine |
Sep, 2028
(3 years from now) | Active |
| US9643929 | Asymmetric catalytic reduction of oxcarbazepine |
Apr, 2026
(1 year, 3 months from now) | Active |
| US10702536 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
May, 2025
(4 months from now) | Active |
| US11364247 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
May, 2025
(4 months from now) | Active |
| US10675287 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
May, 2025
(4 months from now) | Active |
| US10695354 | Methods of treatment of partial onset seizures using eslicarbazepine acetate |
May, 2025
(4 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aptiom's patents.
Latest Legal Activities on Aptiom's Patents
Given below is the list of recent legal activities going on the following patents of Aptiom.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Dec, 2023 | US10702536 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Dec, 2023 | US10695354 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Nov, 2023 | US10675287 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Jun, 2023 | US9206135 |
| Recordation of Patent Grant Mailed Critical | 21 Jun, 2022 | US11364247 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jun, 2022 | US11364247 |
| Email Notification Critical | 02 Jun, 2022 | US11364247 |
| Issue Notification Mailed Critical | 01 Jun, 2022 | US11364247 |
| Application Is Considered Ready for Issue Critical | 26 May, 2022 | US11364247 |
| Dispatch to FDC | 26 May, 2022 | US11364247 |
FDA has granted several exclusivities to Aptiom. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aptiom, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Aptiom.
Exclusivity Information
Aptiom holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Aptiom's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-150) | Aug 27, 2018 |
| New Indication(I-715) | Aug 27, 2018 |
| New Chemical Entity Exclusivity(NCE) | Nov 08, 2018 |
Several oppositions have been filed on Aptiom's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Aptiom's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aptiom patents.
Aptiom's Oppositions Filed in EPO
Aptiom has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 14, 2017, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP08705172A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08842368A | Jun, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Opposition rejected |
| EP08705172A | Jun, 2017 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Revoked |
| EP08705172A | Jun, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
US patents provide insights into the exclusivity only within the United States, but Aptiom is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aptiom's family patents as well as insights into ongoing legal events on those patents.
Aptiom's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aptiom's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aptiom Generic API suppliers:
Eslicarbazepine Acetate is the generic name for the brand Aptiom. 6 different companies have already filed for the generic of Aptiom, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aptiom's generic
How can I launch a generic of Aptiom before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aptiom's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aptiom's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Aptiom -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg, 400 mg, 600 mg and 800 mg | 08 Nov, 2017 | 7 | 29 Jun, 2021 | 24 Aug, 2032 | Deferred |
Alternative Brands for Aptiom
Aptiom which is used for managing partial-onset seizures and absence seizures in patients with epilepsy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Supernus Pharms |
| |||
About Aptiom
Aptiom is a drug owned by Sumitomo Pharma America Inc. It is used for managing partial-onset seizures and absence seizures in patients with epilepsy. Aptiom uses Eslicarbazepine Acetate as an active ingredient. Aptiom was launched by Sumitomo Pharma Am in 2013.
Can you believe Aptiom received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Aptiom was approved by FDA for market use on 08 November, 2013.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Aptiom is 08 November, 2013, its NCE-1 date is estimated to be 08 November, 2017.
Active Ingredient:
Aptiom uses Eslicarbazepine Acetate as the active ingredient. Check out other Drugs and Companies using Eslicarbazepine Acetate ingredient
Treatment:
Aptiom is used for managing partial-onset seizures and absence seizures in patients with epilepsy.
Dosage:
Aptiom is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 400MG | TABLET | Prescription | ORAL |
| 600MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 800MG | TABLET | Prescription | ORAL |