Restasis is a drug owned by Abbvie Inc. It is protected by 7 US drug patents filed from 2013 to 2016 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 27, 2024. Details of Restasis'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). | |||
| US8629111 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US8633162 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US8648048 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US8685930 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US9248191 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US8642556 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 years ago) |
Expired
|
| US5474979 | Nonirritating emulsions for sensitive tissue |
May, 2014
(12 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 Restasis's patents.
Latest Legal Activities on Restasis's Patents
Given below is the list of recent legal activities going on the following patents of Restasis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 09 Mar, 2026 | US8642556 |
| Expire Patent | 23 Feb, 2026 | US8633162 |
| Expire Patent | 16 Feb, 2026 | US8629111 |
| Maintenance Fee Reminder Mailed | 17 Nov, 2025 | US8685930 |
| Maintenance Fee Reminder Mailed | 29 Sep, 2025 | US8648048 |
| Maintenance Fee Reminder Mailed | 22 Sep, 2025 | US8642556 |
| Maintenance Fee Reminder Mailed | 08 Sep, 2025 | US8633162 |
| Maintenance Fee Reminder Mailed | 01 Sep, 2025 | US8629111 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jul, 2023 | US9248191 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Sep, 2021 | US8685930 |
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 and ongoing
litigations to
help you estimate the early arrival of Restasis generic.
Restasis's Litigations
Restasis 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. et al., 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's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
Final Written Decision
(27 Sep, 2019) | Allergan, Inc. | Mylan Pharmaceuticals Inc. et al. |
| US8633162 | January, 2017 |
Final Written Decision
(27 Sep, 2019) | Allergan, Inc. | Teva Pharmaceuticals USA, Inc. |
| US8642556 | June, 2016 |
Final Written Decision
(27 Sep, 2019) | Allergan, Inc. | Mylan Pharmaceuticals Inc. et al. |
| US8642556 | January, 2017 |
Final Written Decision
(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 |
Final Written Decision
(31 Mar, 2017) | Allergan, Inc. | Akorn, Inc. |
| US8642556 | January, 2017 |
Final Written Decision
(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 |
Institution Denied
(16 Dec, 2015) | Allergan, Inc. | Apotex Corp. et al. |
| US8633162 | June, 2015 |
Institution Denied
(16 Dec, 2015) | Allergan, Inc. | Apotex Corp. et al. |
| US8642556 | June, 2015 |
Institution Denied
(16 Dec, 2015) | Allergan, Inc. | Apotex Corp. et al. |
| US8648048 | June, 2015 |
Institution Denied
(16 Dec, 2015) | Allergan, Inc. | Apotex Corp. et al. |
| US8685930 | June, 2015 |
Institution Denied
(16 Dec, 2015) | Allergan, Inc. | Apotex Corp. et al. |
US patents provide insights into the exclusivity only within the United States, but
Restasis 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's family patents as well as insights into
ongoing legal events
on those patents.
Restasis's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Restasis:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Restasis(Cyclosporine) has 1 clinical trial that has been verified in 2024.
Generic Launch
Generic Release Date:
Restasis's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 27, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Restasis Generic API suppliers:
Cyclosporine is the generic name for the brand Restasis. 18 different companies have already filed for the generic of Restasis, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Restasis's generic
How can I launch a generic of Restasis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Restasis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Restasis'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 -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 29 Jan, 2020 | 11 May, 2034 | Less | |||
| 13 Jan, 2014 | 17 May, 2014 | Extinguished | Less |
Alternative Brands for Restasis
Restasis which is used for increasing tear production in patients with keratoconjunctivitis sicca (dry eye)., 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 |
| |||
| Harrow Eye |
| |||
| Sun Pharm |
| |||
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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Cyclosporine, Restasis's active ingredient. Check the complete list of approved generic manufacturers for Restasis
About Restasis
Restasis is a drug owned by Abbvie Inc. It is used for increasing tear production in patients with keratoconjunctivitis sicca (dry eye). Restasis uses Cyclosporine as an active ingredient. Restasis was launched by Abbvie in 2002.
Approval Date:
Restasis was approved by FDA for market use on 23 December, 2002.
Active Ingredient:
Restasis uses Cyclosporine as the active ingredient. Check out other Drugs and Companies using Cyclosporine ingredient
Treatment:
Restasis is used for increasing tear production in patients with keratoconjunctivitis sicca (dry eye).
Dosage:
Restasis 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 |