Kynmobi is a drug owned by Sumitomo Pharma America Inc. It is protected by 19 US drug patents filed from 2020 to 2022. Out of these, 12 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 19, 2036. Details of Kynmobi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10959943 | Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa |
Apr, 2036
(11 years from now) | Active |
| US10449146 | Methods of treating parkinson's disease by administration of apomorphine to an oral mucosa |
Apr, 2036
(11 years from now) | Active |
| US8846074 | Sublingual films |
Dec, 2031
(7 years from now) | Active |
| US8414922 | Sublingual films |
Dec, 2031
(7 years from now) | Active |
| US11419769 | Sublingual films |
Dec, 2031
(7 years from now) | Active |
| US9669021 | Sublingual apomorphine |
Jun, 2030
(5 years from now) | Active |
| US9044475 | Sublingual apomorphine |
Jun, 2030
(5 years from now) | Active |
| US10420763 | Sublingual apomorphine |
Jun, 2030
(5 years from now) | Active |
| US9669019 | Sublingual apomorphine |
Jun, 2030
(5 years from now) | Active |
| US9283219 | Sublingual films |
Jun, 2030
(5 years from now) | Active |
| US9326981 | Sublingual apomorphine |
Jun, 2030
(5 years from now) | Active |
| US10821074 | Sublingual and buccal film compositions |
Aug, 2029
(4 years from now) | Active |
| US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Apr, 2024
(7 months ago) |
Expired
|
| US8765167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb, 2024
(9 months ago) |
Expired
|
| US8663687 | Film compositions for delivery of actives |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US10888499 | Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom |
Feb, 2022
(2 years ago) |
Expired
|
| US9855221 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb, 2022
(2 years ago) |
Expired
|
| US11077068 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb, 2022
(2 years ago) |
Expired
|
| US9931305 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Feb, 2022
(2 years ago) |
Expired
|
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 Kynmobi's patents.
Latest Legal Activities on Kynmobi's Patents
Given below is the list of recent legal activities going on the following patents of Kynmobi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Nov, 2023 | US9326981 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Sep, 2023 | US9283219 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Apr, 2023 | US10449146 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Mar, 2023 | US10420763 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Mar, 2023 | US8414922 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Mar, 2023 | US11419769 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Mar, 2023 | US9283219 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Mar, 2023 | US10959943 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Mar, 2023 | US10449146 |
| Correspondence Address Change Critical | 09 Mar, 2023 | US10959943 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Kynmobi and ongoing litigations to help you estimate the early arrival of Kynmobi generic.
Kynmobi's Litigations
Kynmobi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 28, 2014, against patent number US8765167. The petitioner BioDelivery Sciences International, Inc., challenged the validity of this patent, with MonoSol Rx, LLC. as the respondent. Click below to track the latest information on how companies are challenging Kynmobi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Par Pharmaceutical, Inc. |
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Dr. Reddy’s Laboratories, Inc. |
| US8603514 | November, 2016 |
Terminated-Settled
(06 Oct, 2017) | MonoSol Rx, LLC et al. | Mylan Technologies, Inc. et al. |
| US8603514 | May, 2016 |
Terminated-Denied
(05 Dec, 2016) | MonoSol Rx, LLC | Dr. Reddy's Laboratories, Inc. |
| US8603514 | December, 2015 |
Terminated-Denied
(23 May, 2016) | MONOSOL RX LLC | Teva Pharmaceuticals USA Inc |
| US8765167 | October, 2014 |
FWD Entered
(24 Mar, 2016) | MonoSol Rx, LLC. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Terminated-Settled
(24 Mar, 2016) | MonoSol Rx, LLC. et al. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Terminated-Denied
(20 May, 2015) | MonoSol Rx, LLC. | BioDelivery Sciences International, Inc. |
FDA has granted some exclusivities to Kynmobi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kynmobi, 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 Kynmobi.
Exclusivity Information
Kynmobi holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Kynmobi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 21, 2023 |
Several oppositions have been filed on Kynmobi'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 Kynmobi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kynmobi patents.
Kynmobi's Oppositions Filed in EPO
Kynmobi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 11, 2012, by Lts Lohmann Therapie-Systeme Ag. This opposition was filed on patent number EP02801042A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP15175258A | May, 2019 | D Young & Co LLP | Granted and Under Opposition |
| EP10786915A | May, 2016 | LTS LOHMANN Therapie-Systeme AG | Granted and Under Opposition |
| EP10786915A | May, 2016 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP11157819A | Jun, 2014 | Ahrens, Gabriele | Patent maintained as amended |
| EP02782151A | Jun, 2013 | Acino Pharma AG | Revoked |
| EP02782151A | Jun, 2013 | Germann, Sandra | Revoked |
| EP02801042A | Sep, 2012 | Ahrens, Gabriele | Patent maintained as amended |
| EP02801042A | Sep, 2012 | LTS LOHMANN Therapie-Systeme AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Kynmobi 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 Kynmobi's family patents as well as insights into ongoing legal events on those patents.
Kynmobi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kynmobi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 19, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kynmobi Generic API suppliers:
Apomorphine Hydrochloride is the generic name for the brand Kynmobi. 1 company has already filed for the generic of Kynmobi. Check out the entire list of companies who have already received approval for Kynmobi's generic
About Kynmobi
Kynmobi is a drug owned by Sumitomo Pharma America Inc. It is used for managing 'off' episodes in patients with Parkinson's disease. Kynmobi uses Apomorphine Hydrochloride as an active ingredient. Kynmobi was launched by Sumitomo Pharma Am in 2020.
Approval Date:
Kynmobi was approved by FDA for market use on 21 May, 2020.
Active Ingredient:
Kynmobi uses Apomorphine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Apomorphine Hydrochloride ingredient
Treatment:
Kynmobi is used for managing 'off' episodes in patients with Parkinson's disease.
Dosage:
Kynmobi is available in film form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | FILM | Discontinued | SUBLINGUAL |
| 20MG | FILM | Discontinued | SUBLINGUAL |
| 15MG | FILM | Discontinued | SUBLINGUAL |
| 25MG | FILM | Discontinued | SUBLINGUAL |
| 30MG | FILM | Discontinued | SUBLINGUAL |