Restasis Multidose Patent Expiration

Restasis Multidose is a drug owned by Abbvie Inc. It is protected by 10 US drug patents filed from 2016 to 2017. Out of these, 4 drug patents are active and 6 have expired. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9669974 Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
May, 2034

(9 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
US8561859 Dispensing device
Apr, 2032

(7 years from now)

Active
US8292129 Dispensing device
Feb, 2031

(6 years from now)

Active
US8685930 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months ago)

Expired
US8648048 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months ago)

Expired
US8642556 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months ago)

Expired
US8633162 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months ago)

Expired
US9248191 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months ago)

Expired
US8629111 Methods of providing therapeutic effects using cyclosporin components
Aug, 2024

(3 months 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 Restasis Multidose's patents.

Given below is the list of recent legal activities going on the following patents of Restasis Multidose.

Activity Date Patent Number
Patent litigations
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 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 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.

Last updated on November 26, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8629111 June, 2016 Terminated
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc. et al.
US8629111 January, 2017 Terminated
(27 Sep, 2019)
Allergan, Inc. Akorn, Inc.
US8633162 June, 2016 FWD Entered
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc.
US8633162 January, 2017 FWD Entered
(27 Sep, 2019)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US8642556 June, 2016 FWD Entered
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc.
US8642556 January, 2017 FWD Entered
(27 Sep, 2019)
Allergan, Inc. Akorn, Inc.
US8648048 June, 2016 Terminated
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc. et al.
US8648048 January, 2017 Terminated
(27 Sep, 2019)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US8685930 June, 2016 Terminated
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc. et al.
US8685930 January, 2017 Terminated
(27 Sep, 2019)
Allergan, Inc. Akorn, Inc.
US9248191 June, 2016 Terminated
(27 Sep, 2019)
Allergan, Inc. Mylan Pharmaceuticals Inc. et al.
US9248191 January, 2017 Terminated
(27 Sep, 2019)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US8629111 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US8633162 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US8642556 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US8648048 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US8685930 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US9248191 January, 2017 Terminated-Settled
(06 Sep, 2017)
Allergan, Inc. Famy Care Limited
US8629111 January, 2017 Terminated
(31 Mar, 2017)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US8633162 January, 2017 FWD Entered
(31 Mar, 2017)
Allergan, Inc. Akorn, Inc.
US8642556 January, 2017 FWD Entered
(31 Mar, 2017)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US8648048 January, 2017 Terminated
(31 Mar, 2017)
Allergan, Inc. Akorn, Inc.
US8685930 January, 2017 Terminated
(31 Mar, 2017)
Allergan, Inc. Teva Pharmaceuticals USA, Inc.
US9248191 January, 2017 Terminated
(31 Mar, 2017)
Allergan, Inc. Akorn, Inc.
US8629111 June, 2016 Terminated-Settled
(08 Dec, 2016)
Allergan, Inc. Argentum Pharmaceuticals LLC
US8629111 June, 2015 Terminated-Denied
(16 Dec, 2015)
Allergan, Inc. Apotex Corp.
US8633162 June, 2015 Terminated-Denied
(16 Dec, 2015)
Allergan, Inc. Apotex Corp.
US8642556 June, 2015 Terminated-Denied
(16 Dec, 2015)
Allergan, Inc. Apotex Corp.
US8648048 June, 2015 Terminated-Denied
(16 Dec, 2015)
Allergan, Inc. Apotex Corp.
US8685930 June, 2015 Terminated-Denied
(16 Dec, 2015)
Allergan, Inc. Apotex Corp.

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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
Patent litigations
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

Restasis Multidose has patent protection in a total of 26 countries. It's US patent count contributes only to 26.0% of its total global patent coverage. Click below to unlock the full patent family tree for Restasis Multidose.

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 Generic API suppliers:

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

Alternative Brands for Restasis Multidose

Restasis Multidose which is used for treating dry eye by increasing tear production in patients with keratoconjunctivitis sicca., has several other brand drugs in the same treatment category and using the same active ingredient (Cyclosporine). 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
Abbvie
Restasis

(uses Cyclosporine)

Used for increasing tear production in patients with keratoconjunctivitis sicca (dry eye).
Harrow Eye
Vevye

(uses Cyclosporine)

Used for managing symptoms of dry eye disease.
Sun Pharm
Cequa

(uses Cyclosporine)

Used for increasing tear production in patients with dry eye (keratoconjunctivitis sicca).

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Cyclosporine. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Harrow Eye
Verkazia
Novartis
Neoral


Apart from brand drugs containing the same ingredient, some generics have also been filed for Cyclosporine, Restasis Multidose's active ingredient. Check the complete list of approved generic manufacturers for Restasis Multidose





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.

Approval 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