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
(3 months from now) | Active |
| US8772338 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8299118 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US9241918 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8278353 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8933127 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8933120 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8586630 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8524777 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US9155716 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 months from now) | Active |
| US8338479 | Enhanced bimatoprost ophthalmic solution |
Mar, 2025
(3 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.
Latest 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 |
|---|---|---|
 | ||
| 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
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.
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 |