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 months ago) |
Expired
|
| US8633162 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 months ago) |
Expired
|
| US8648048 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 months ago) |
Expired
|
| US8685930 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 months ago) |
Expired
|
| US9248191 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 months ago) |
Expired
|
| US8642556 | Methods of providing therapeutic effects using cyclosporin components |
Aug, 2024
(2 months ago) |
Expired
|
| US5474979 | Nonirritating emulsions for sensitive tissue |
May, 2014
(10 years ago) |
Expired
|
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., 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 |
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. |
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. 14 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 | 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
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 |