Restasis Multidose is a drug owned by Abbvie Inc. It is protected by 10 US drug patents filed from 2016 to 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 11, 2034. Details of Restasis Multidose'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8633162 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US9248191 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US8629111 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US8685930 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US8648048 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US8642556 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(a month from now) | Active |
| US8292129 | Dispensing device |
Feb, 2031
(6 years from now) | Active |
| US8561859 | Dispensing device |
Apr, 2032
(7 years from now) | Active |
| US9676525 | Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids |
Feb, 2034
(9 years from now) | Active |
| US9669974 | Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids |
May, 2034
(9 years 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 Restasis Multidose's patents.
Latest Legal Activities on Restasis Multidose's Patents
Given below is the list of recent legal activities going on the following patents of Restasis Multidose.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Apr, 2024 | US8292129 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Apr, 2021 | US8561859 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Dec, 2020 | US9676525 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2020 | US9669974 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2020 | US8292129 |
| Patent Issue Date Used in PTA Calculation | 13 Jun, 2017 | US9676525 |
| Recordation of Patent Grant Mailed | 13 Jun, 2017 | US9676525 |
| Patent Issue Date Used in PTA Calculation | 06 Jun, 2017 | US9669974 |
| Recordation of Patent Grant Mailed | 06 Jun, 2017 | US9669974 |
| Email Notification | 25 May, 2017 | US9676525 |
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 Restasis Multidose and ongoing litigations to help you estimate the early arrival of Restasis Multidose generic.
Restasis Multidose's Litigations
Restasis Multidose has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 04, 2015, against patent number US8685930. The petitioner Apotex Corp., challenged the validity or infringement of this patent, with Allergan, Inc. as the respondent. Click below to track the latest information on how companies are challenging Restasis Multidose's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8629111 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Akorn, Inc. |
| US8629111 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8629111 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US8633162 | January, 2017 | FWD Entered | Allergan, Inc. | Akorn, Inc. |
| US8633162 | January, 2017 | FWD Entered | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8633162 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US8642556 | January, 2017 | FWD Entered | Allergan, Inc. | Akorn, Inc. |
| US8642556 | January, 2017 | FWD Entered | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8642556 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US8648048 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Akorn, Inc. |
| US8648048 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8648048 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US8685930 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Akorn, Inc. |
| US8685930 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8685930 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US9248191 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Akorn, Inc. |
| US9248191 | January, 2017 | Terminated-Dismissed | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US9248191 | January, 2017 | Terminated-Settled | Allergan, Inc. | Famy Care Limited |
| US8629111 | June, 2016 | Terminated-Settled | Allergan, Inc. | Argentum Pharmaceuticals LLC |
| US8629111 | June, 2016 | Terminated-Dismissed | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US8633162 | June, 2016 | FWD Entered | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US8642556 | June, 2016 | FWD Entered | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US8648048 | June, 2016 | Terminated-Dismissed | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US8685930 | June, 2016 | Terminated-Dismissed | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US9248191 | June, 2016 | Terminated-Dismissed | Allergan, Inc. | Mylan Pharmaceuticals Inc. |
| US8629111 | June, 2015 | Terminated-Denied | Allergan, Inc. | Apotex Corp. |
| US8633162 | June, 2015 | Terminated-Denied | Allergan, Inc. | Apotex Corp. |
| US8642556 | June, 2015 | Terminated-Denied | Allergan, Inc. | Apotex Corp. |
| US8648048 | June, 2015 | Terminated-Denied | Allergan, Inc. | Apotex Corp. |
| US8685930 | June, 2015 | Terminated-Denied | Allergan, Inc. | Apotex Corp. |
Several oppositions have been filed on Restasis Multidose'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 Restasis Multidose's generic, the next section provides detailed information on ongoing and past EP oppositions related to Restasis Multidose patents.
Restasis Multidose's oppositions filed in EPO
Restasis Multidose has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 30, 2018, by Epping Hermann Fischer Patentanwaltgesellschaft Mbh. This opposition was filed on patent number EP14815668A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP14815668A | Oct, 2018 | Epping Hermann Fischer Patentanwaltgesellschaft MBH | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Restasis Multidose 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 Restasis Multidose's family patents as well as insights into ongoing legal events on those patents.
Restasis Multidose's family patents
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Generic Launch
Generic Release Date:
Restasis Multidose's generic launch date based on the expiry of its last outstanding patent is estimated to be May 11, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Restasis Multidose Generics:
Cyclosporine is the generic name for the brand Restasis Multidose. 14 different companies have already filed for the generic of Restasis Multidose, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Restasis Multidose's generic
How can I launch a generic of Restasis Multidose before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Restasis Multidose's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Restasis Multidose'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 Restasis Multidose -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 13 Jan, 2014 | 1 | 17 May, 2014 | Extinguished |
About Restasis Multidose
Restasis Multidose is a drug owned by Abbvie Inc. It is used for treating dry eye by increasing tear production in patients with keratoconjunctivitis sicca. Restasis Multidose uses Cyclosporine as an active ingredient. Restasis Multidose was launched by Abbvie in 2002.
Market Authorisation Date:
Restasis Multidose was approved by FDA for market use on 23 December, 2002.
Active Ingredient:
Restasis Multidose uses Cyclosporine as the active ingredient. Check out other Drugs and Companies using Cyclosporine ingredient
Treatment:
Restasis Multidose is used for treating dry eye by increasing tear production in patients with keratoconjunctivitis sicca.
Dosage:
Restasis Multidose is available in emulsion form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% | EMULSION | Prescription | OPHTHALMIC |