Vevye Patent Expiration

Vevye is a drug owned by Harrow Eye Llc. It is protected by 5 US drug patents filed from 2023 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 01, 2042. Details of Vevye'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).
US12059449 Ophthalmic composition for treatment of dry eye disease
Apr, 2042

(17 years from now)

Active
US11413323 Ophthalmic composition for treatment of dry eye disease
Oct, 2039

(14 years from now)

Active
US11154513 Semifluorinated compounds
Nov, 2038

(14 years from now)

Active
US10813976 Ophthalmic compositions comprising ciclosporin
Sep, 2037

(12 years from now)

Active
US8614178 Pharmaceutical composition for treatment of dry eye syndrome
Dec, 2030

(6 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 Vevye's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 19 Apr, 2024 US10813976
Electronic Review 24 May, 2023 US11413323
Post Issue Communication - Certificate of Correction 05 May, 2023 US11413323
Patent Issue Date Used in PTA Calculation 16 Aug, 2022 US11413323
Recordation of Patent Grant Mailed 16 Aug, 2022 US11413323
Email Notification 28 Jul, 2022 US11413323
Issue Notification Mailed 27 Jul, 2022 US11413323
Dispatch to FDC 22 Jun, 2022 US11413323
Application Is Considered Ready for Issue 22 Jun, 2022 US11413323
Issue Fee Payment Received 19 Jun, 2022 US11413323


FDA has granted several exclusivities to Vevye. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vevye, 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 Vevye.

Exclusivity Information

Vevye holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Vevye's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) May 30, 2026

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US patents provide insights into the exclusivity only within the United States, but Vevye 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 Vevye's family patents as well as insights into ongoing legal events on those patents.

Vevye's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Vevye:

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. Vevye(Cyclosporine) has 1 clinical trial that has been verified in 2024.

Title Lead Sponsor Collaborators Status Phases
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia Novartis Pharmaceuticals ACTIVE NOT RECRUITING
(Oct, 2024)
PHASE2
The Effect of Cyclosporin Before Cataract Surgery Samsung Medical Center COMPLETED
(May, 2022)
PHASE4
Efficacy and Safety of Lenalidomide in Combination With Cyclosporine A in Patients With Myelodysplastic Syndromes Weill Medical College of Cornell University Celgene TERMINATED
(Nov, 2019)
PHASE2
Investigation of Flare and Remission in Subjects With Atopic Dermatitis LEO Pharma WITHDRAWN
(Jul, 2019)
PHASE4
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum London School of Hygiene and Tropical Medicine Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia COMPLETED
(Mar, 2015)
PHASE2
Restasis for Treatment of Brittle Nails Julian M. Mackay-Wiggan Allergan COMPLETED
(Jul, 2013)
PHASE2
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients APT Pharmaceuticals, Inc. NO LONGER AVAILABLE
(Sep, 2012)
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection Novartis Pharmaceuticals COMPLETED
(Jul, 2012)
PHASE3
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation Assistance Publique - Hôpitaux de Paris Agence de La Biomédecine COMPLETED
(Jul, 2009)
PHASE2
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes Georgetown University COMPLETED
(May, 2009)
NA




Generic Launch

Generic Release Date:

Vevye's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 01, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Vevye Generic API suppliers:

Cyclosporine is the generic name for the brand Vevye. 14 different companies have already filed for the generic of Vevye, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vevye's generic

Alternative Brands for Vevye

Vevye which is used for managing symptoms of dry eye disease., 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).
Restasis Multidose

(uses Cyclosporine)

Used for treating dry eye by increasing tear production in patients with keratoconjunctivitis sicca.
Bausch And Lomb Inc
Miebo Used for managing dry eye disease symptoms.
Xiidra Used for relieving symptoms of dry eye disease.
Oyster Point Pharma
Tyrvaya Used for treating dry eye disease symptoms.
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, Vevye's active ingredient. Check the complete list of approved generic manufacturers for Vevye





About Vevye

Vevye is a drug owned by Harrow Eye Llc. It is used for managing symptoms of dry eye disease. Vevye uses Cyclosporine as an active ingredient. Vevye was launched by Harrow Eye in 2023.

Approval Date:

Vevye was approved by FDA for market use on 30 May, 2023.

Active Ingredient:

Vevye uses Cyclosporine as the active ingredient. Check out other Drugs and Companies using Cyclosporine ingredient

Treatment:

Vevye is used for managing symptoms of dry eye disease.

Dosage:

Vevye is available in solution form for ophthalmic use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.1% SOLUTION Prescription OPHTHALMIC