LUMIGAN Drug Patent Profile

When do Lumigan patents expire, and what generic alternatives are available?

Lumigan is a drug marketed by Abbvie and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-four patent family members in twenty-two countries.

The generic ingredient in LUMIGAN is bimatoprost. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bimatoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lumigan

A generic version of LUMIGAN was approved as bimatoprost by APOTEX on December 1^st, 2014.

Summary for LUMIGAN

International Patents:	34
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	46
Patent Applications:	4,681
Drug Prices:	Drug price information for LUMIGAN
Drug Sales Revenues:	Drug sales revenues for LUMIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMIGAN
What excipients (inactive ingredients) are in LUMIGAN?	LUMIGAN excipients list
DailyMed Link:	LUMIGAN at DailyMed

See drug prices for LUMIGAN

See drug sales revenues for LUMIGAN

Recent Clinical Trials for LUMIGAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Laboratoires Thea	Phase 1
Amneal Pharmaceuticals, LLC	Phase 3
CBCC Global Research	Phase 3

See all LUMIGAN clinical trials

Pharmacology for LUMIGAN

Drug Class

Prostaglandin Analog

Paragraph IV (Patent) Challenges for LUMIGAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUMIGAN	Ophthalmic Solution	bimatoprost	0.01%	022184	1	2011-04-05
LUMIGAN	Ophthalmic Solution	bimatoprost	0.03%	021275	1	2008-12-22

US Patents and Regulatory Information for LUMIGAN

LUMIGAN is protected by thirteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	8,309,605
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	8,772,338		Y
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	9,155,716		Y
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	8,933,120		Y
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	8,299,118
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001		DISCN	Yes	No
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010		RX	Yes	Yes	8,586,630

Expired US Patents for LUMIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	8,017,655
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010	5,688,819
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	6,403,649
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	021275-001	Mar 16, 2001	5,688,819
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010	8,017,655
Abbvie	LUMIGAN	bimatoprost	SOLUTION/DROPS;OPHTHALMIC	022184-001	Aug 31, 2010	6,403,649

EU/EMA Drug Approvals for LUMIGAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Lumigan	bimatoprost	EMEA/H/C/000391 Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).,	Authorised	no	no	no	2002-03-08

International Patents for LUMIGAN

See the table below for patents covering LUMIGAN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20070113292	ENHANCED BIMATOPROST OPHTHALMIC SOLUTION
Spain	2324058
Japan	5899267
Russian Federation	2363471	УЛУЧШЕННЫЙ ОФТАЛЬМИЧЕСКИЙ РАСТВОР БИМАТОПРОСТА (IMPROVED BIMATOPROST OPHTHALMIC SOLUTION)
Australia	5792496
European Patent Office	0825980	UTILISATION DE DERIVES D'ACIDE CYCLOPENTANE HEPTAN(ENE)OIQUE, 2-HETEROARYLALKENYLE EN TANT QU'AGENTS THERAPEUTIQUES POUR LE TRAITEMENT DE L'HYPERTENSION OCULAIRE (CYCLOPENTANE HEPTAN(ENE)OIC ACID, 2-HETEROARYLAKENYL DERIVATIVES AS THERAPEUTIC AGENTS FOR THE TREATMENT OF OCULAR HYPERTENSION)
Germany	69331233	2-ZYKLOALKYL-ODER ARYLALKYL-DERIVATE VON NICHT-SÄURE, ZYKLOPENTANE-HEPTANOIC-SÄURE

Supplementary Protection Certificates for LUMIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0660716	SPC023/2002	Ireland		SPC023/2002: 20040929, EXPIRES: 20170307
0660716	C300099	Netherlands		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION: EU/1/02/205/001 20020308
0660716	CA 2002 00020	Denmark
0660716	90957	Luxembourg
0660716	02C0033	France		PRODUCT NAME: BIMATOPROST; NAT. REGISTRATION NO/DATE: EU/1/02/205/001 20020308; FIRST REGISTRATION:
0660716	SPC/GB02/035	United Kingdom		PRODUCT NAME: BIMATOPROST; REGISTERED: UK EU/1/02/205/001 20020308

LUMIGAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lumigan

Introduction

Lumigan, a prostaglandin analog used to treat glaucoma and ocular hypertension, is a significant player in the ophthalmic pharmaceutical market. However, its high price has been a subject of discussion among patients, healthcare providers, and industry analysts. This article delves into the market dynamics and financial trajectory of Lumigan, exploring the factors that influence its pricing and the broader implications for the pharmaceutical industry.

Research and Development Costs

One of the primary drivers of Lumigan's high price is the substantial investment in research and development (R&D). Bringing a drug like Lumigan to market involves extensive clinical trials and regulatory approvals, which are costly endeavors. Pharmaceutical companies, including Allergan, the manufacturer of Lumigan, invest billions of dollars in these processes, and these expenses are often reflected in the final product price[1].

Marketing and Branding Expenses

Marketing and branding play a crucial role in the pharmaceutical industry, and Lumigan is no exception. Allergan spends considerable resources on advertising and promotional activities to build brand loyalty among healthcare providers and consumers. These marketing expenses contribute significantly to the overall cost of the medication, as companies aim to recoup their investments through higher prices[1].

Patent Protections

Patent protections are a critical factor in maintaining the high price of Lumigan. These patents grant Allergan market exclusivity for several years, allowing the company to set prices without facing competition from generic alternatives. During this period, Allergan can use its pricing freedom to recoup substantial investments in R&D and marketing, often resulting in steep medication costs. Strategies such as "evergreening," where minor modifications are patented to prolong market exclusivity, also help in maintaining high prices[1].

Market Demand and Lack of Price Regulation

The demand for effective glaucoma treatments is high, and Lumigan benefits from this strong market demand. Patients are often willing to pay a premium to maintain their eye health, which drives up the prices. Additionally, the lack of price regulation in the U.S. pharmaceutical market allows companies to set prices as they see fit, leading to regular price increases[1].

Comparative Pricing

Lumigan is one of the pricier options among glaucoma eye drops. A 2.5 mL bottle can cost up to $300, leading to an annual expense of around $4,500 if 15 bottles are needed per year. While it is competitive with other branded prostaglandin analogs like Xalatan and Travatan Z, generic alternatives are significantly cheaper, making them more affordable choices for patients[1].

Impact of Patent Expiration

The expiration of patents can significantly alter the pricing landscape for medications like Lumigan. Once patents expire, generic versions can enter the market, leading to increased competition and typically lower drug prices. This shift can make the medication more accessible to patients but also impacts the revenue streams of the original manufacturer[4].

Financial Performance of Allergan and AbbVie

Allergan, now part of AbbVie, reports significant financial metrics that reflect the performance of its pharmaceutical portfolio, including Lumigan. AbbVie's full-year net revenues for 2023 were $54.318 billion, with a notable portion coming from its ophthalmic and other therapeutic areas. The company's R&D expenses, which include investments in drugs like Lumigan, were 13.5% of net revenues, highlighting the ongoing commitment to innovation and product development[2][5].

Market Growth and Trends

The global antiglaucoma eye drops market is expected to register a steady revenue CAGR over the forecast period, driven by the increasing usage of drugs like Lumigan, Xalatan, and Travatan. However, this growth is also influenced by factors such as patent expirations and the introduction of generic versions, which can impact market dynamics and pricing strategies[4].

Regulatory Oversight

Regulatory oversight from bodies like the FDA ensures that pharmaceuticals meet strict standards of quality and purity. This oversight can require additional testing and compliance measures, further driving up production expenses and contributing to the final cost of the medication[1].

Consumer Impact and Access

The high cost of Lumigan can be burdensome for patients, many of whom rely on this medication for managing their glaucoma. Limited insurance coverage and high out-of-pocket costs often lead patients to explore more affordable alternatives or savings programs. Understanding the factors behind Lumigan's pricing can help patients navigate these financial challenges and make informed decisions about their healthcare[1].

Ethical Considerations

The pricing strategies employed by pharmaceutical companies, including the use of patent protections and evergreening, raise ethical concerns. These tactics can delay the entry of generic alternatives, maintaining high prices and limiting access to essential medications for some patients. This highlights the need for a balanced approach that considers both the financial sustainability of pharmaceutical companies and the healthcare needs of patients[1].

Future Outlook

As the pharmaceutical landscape evolves, the pricing of Lumigan and similar medications will continue to be influenced by market demand, regulatory changes, and the introduction of new treatments. Companies like AbbVie are expected to maintain high single-digit compound annual revenue growth rates through 2029, driven by their diverse therapeutic portfolios and ongoing R&D investments[2][5].

Key Takeaways

• Research and Development Costs: Substantial investments in clinical trials and regulatory approvals drive up the price of Lumigan.
• Marketing and Branding Expenses: Significant marketing expenses contribute to the overall cost and help maintain brand loyalty.
• Patent Protections: Market exclusivity granted by patents allows Allergan to set high prices without competition.
• Market Demand and Lack of Price Regulation: Strong demand and lack of price regulation in the U.S. contribute to regular price increases.
• Comparative Pricing: Lumigan is pricier than generic alternatives but competitive with other branded options.
• Impact of Patent Expiration: Patent expiration can lead to lower prices due to increased generic competition.
• Financial Performance: AbbVie's financial metrics reflect the performance of its pharmaceutical portfolio, including Lumigan.
• Market Growth and Trends: The antiglaucoma eye drops market is expected to grow, influenced by patent expirations and generic introductions.
• Regulatory Oversight: Strict regulatory standards contribute to production expenses and final product costs.
• Consumer Impact and Access: High costs can be burdensome for patients, leading them to seek affordable alternatives.
• Ethical Considerations: Pricing strategies raise ethical concerns about access to essential medications.

FAQs

Q: Why is Lumigan so expensive?

Lumigan's high price is due to extensive R&D costs, significant marketing expenses, patent protections, and strong market demand.

Q: How do patent protections affect Lumigan's price?

Patent protections grant Allergan market exclusivity, allowing the company to set high prices without competition from generic alternatives.

Q: What are the implications of patent expiration for Lumigan?

Once patents expire, generic versions can enter the market, leading to increased competition and typically lower drug prices.

Q: How does regulatory oversight impact the cost of Lumigan?

Regulatory oversight requires additional testing and compliance measures, further driving up production expenses and contributing to the final cost.

Q: What are the ethical concerns surrounding Lumigan's pricing?

The use of patent protections and evergreening strategies raises ethical concerns about limiting access to essential medications and maintaining high prices.

Sources

1. Polar bear Meds: Why Is Lumigan so Expensive?
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results
3. IU ScholarWorks: Omidenepag isopropyl ophthalmic solution for open-angle glaucoma
4. Reports and Data: Antiglaucoma Eye Drops Market Size, Share, Trends & Forecast 2028
5. PR Newswire: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results