Lumigan Patent Expiration

Lumigan is a drug owned by Abbvie Inc. It is protected by 15 US drug patents filed from 2013 to 2016. Out of these, 12 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 13, 2027. Details of Lumigan's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7851504 Enhanced bimatoprost ophthalmic solution
Jun, 2027

(2 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8309605 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8772338 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8299118 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US9241918 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8278353 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8933127 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8933120 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8586630 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8524777 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US9155716 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US8338479 Enhanced bimatoprost ophthalmic solution
Mar, 2025

(4 months from now)

Active
US5688819 Cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents
Aug, 2014

(10 years ago)

Expired
US8017655 Non-acidic cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents
Nov, 2012

(11 years ago)

Expired
US6403649 Non-acidic cyclopentane heptanoic acid,2-cycloalkyl or arylalkyl derivatives as therapeutic agents
Sep, 2012

(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 Lumigan's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 10 May, 2024 US8338479 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 11 Apr, 2024 US8309605 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 14 Mar, 2024 US8299118 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 14 Mar, 2024 US8278353 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 08 Jun, 2022 US8933120
Payment of Maintenance Fee, 12th Year, Large Entity 11 May, 2022 US7851504 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 09 Dec, 2021 US8772338 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 19 May, 2021 US8586630 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 03 Mar, 2021 US8524777
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jun, 2020 US8338479 (Litigated)


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 Lumigan and ongoing litigations to help you estimate the early arrival of Lumigan generic.

Lumigan's Litigations

Lumigan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 13, 2009, against patent number US7851504. The petitioner , challenged the validity of this patent, with Chin-Ming Chang et al as the respondent. Click below to track the latest information on how companies are challenging Lumigan's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7851504 January, 2009 Decision
(10 May, 2010)
Chin-Ming Chang et al


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

Exclusivity Information

Lumigan holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Lumigan's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Aug 31, 2013

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Several oppositions have been filed on Lumigan'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 Lumigan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lumigan patents.

Lumigan's Oppositions Filed in EPO

Lumigan has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 11, 2010, by Ratiopharm Gmbh. This opposition was filed on patent number EP06738208A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP06738208A Feb, 2010 Teva Pharmaceutical Industries Ltd. Patent maintained as amended
EP06738208A Feb, 2010 Ratiopharm GmbH Patent maintained as amended


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

Lumigan's Family Patents

Lumigan has patent protection in a total of 22 countries. It's US patent count contributes only to 45.7% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Lumigan.

Family Patents

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Generic Launch

Generic Release Date:

Lumigan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 13, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Lumigan Generics:

Bimatoprost is the generic name for the brand Lumigan. 9 different companies have already filed for the generic of Lumigan, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lumigan's generic

How can I launch a generic of Lumigan before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Lumigan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lumigan'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 Lumigan -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.0001 05 Apr, 2011 1 13 Jun, 2027
0.0003 22 Dec, 2008 1 Extinguished

Alternative Brands for Lumigan

Lumigan which is used for lowering intraocular pressure in patients with glaucoma or ocular hypertension., has several other brand drugs in the same treatment category and using the same active ingredient (Bimatoprost). 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
Combigan used for lowering elevated intraocular pressure in patients with glaucoma or ocular hypertension.
Thea Pharma
Iyuzeh Used for reducing intraocular pressure in patients with ocular hypertension and glaucoma.

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. Bimatoprost. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Abbvie
Durysta
Latisse


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





About Lumigan

Lumigan is a drug owned by Abbvie Inc. It is used for lowering intraocular pressure in patients with glaucoma or ocular hypertension. Lumigan uses Bimatoprost as an active ingredient. Lumigan was launched by Abbvie in 2010.

Approval Date:

Lumigan was approved by FDA for market use on 31 August, 2010.

Active Ingredient:

Lumigan uses Bimatoprost as the active ingredient. Check out other Drugs and Companies using Bimatoprost ingredient

Treatment:

Lumigan is used for lowering intraocular pressure in patients with glaucoma or ocular hypertension.

Dosage:

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

Strength Dosage Form Availability Application Pathway
0.01% SOLUTION/DROPS Prescription OPHTHALMIC
0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS Discontinued OPHTHALMIC