LATISSE Drug Patent Profile

When do Latisse patents expire, and when can generic versions of Latisse launch?

Latisse is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in eight countries.

The generic ingredient in LATISSE 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 Latisse

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

Summary for LATISSE

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	8
Patent Applications:	4,681
Drug Prices:	Drug price information for LATISSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATISSE
What excipients (inactive ingredients) are in LATISSE?	LATISSE excipients list
DailyMed Link:	LATISSE at DailyMed

See drug prices for LATISSE

Recent Clinical Trials for LATISSE

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

Sponsor	Phase
Tulane University	Early Phase 1
Allergan	Early Phase 1
Allergan	Phase 3

See all LATISSE clinical trials

Pharmacology for LATISSE

Drug Class

Prostaglandin Analog

Paragraph IV (Patent) Challenges for LATISSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LATISSE	Topical Solution	bimatoprost	0.03%	022369	1	2010-05-03

US Patents and Regulatory Information for LATISSE

LATISSE is protected by two 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	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	AT	RX	Yes	Yes	8,101,161

Expired US Patents for LATISSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,758,733
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	9,216,183
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,038,988
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,632,760
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	6,403,649

EU/EMA Drug Approvals for LATISSE

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 LATISSE

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

Country	Patent Number	Title	Estimated Expiration
China	1522135
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
Australia	2012261499	Method of enhancing hair growth

Supplementary Protection Certificates for LATISSE

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:

LATISSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Latisse (Bimatoprost)

Introduction to Latisse (Bimatoprost)

Latisse, known chemically as Bimatoprost (CAS 155206-00-1), is a synthetic prostamide used in the treatment of various ophthalmic conditions and cosmetic applications. It is primarily marketed by Allergan and is available in both ophthalmic solution and implant forms.

Market Size and Growth

The global Latisse (Bimatoprost) market has been experiencing significant growth. As of 2023, the market size was valued at several million dollars and is anticipated to reach even higher figures by 2030, with a projected compound annual growth rate (CAGR) during the forecast period of 2024-2030[4].

Regional Analysis

The market is segmented geographically, with North America being the largest market, holding approximately 90% of the global share. This dominance is due to high demand, advanced healthcare infrastructure, and strong market presence of key players in this region[4].

Application Segmentation

Latisse (Bimatoprost) is used in several applications:

• Patented Product: This segment is expected to expand significantly, retaining its position throughout the forecast period due to its efficacy in treating ocular hypertension and glaucoma, as well as its cosmetic use in treating eyelash hypotrichosis[1][4].
• General Products: These include off-patent versions and other formulations, which also contribute to the market growth but at a slower pace compared to patented products.

Key Players and Market Share

The global Latisse (Bimatoprost) market is dominated by a few key players, including:

• Cayman Pharma
• TCS Group
• Tecoland Corporation
• Changzhou BOHIV
• Zhejiang Ausun
• Ansion Pharma
• Lianmin Biochemical
• Chirogate International
• Everlight Chemical
• GENTEC

These top three players collectively hold around 40% of the market share[4].

Drivers and Opportunities

Several factors drive the growth of the Latisse (Bimatoprost) market:

• Increasing Prevalence of Ocular Conditions: The rising incidence of ocular hypertension and glaucoma globally drives the demand for effective treatments like Bimatoprost.
• Cosmetic Applications: The use of Latisse for eyelash growth has become increasingly popular, contributing to market growth.
• Technological Advancements: Continuous research and development in prostamides and ophthalmic solutions enhance the efficacy and safety of Bimatoprost, attracting more users[3].

Restraints and Challenges

Despite the growth, the market faces several challenges:

• Regulatory Hurdles: Strict regulatory approvals and compliance requirements can slow down market expansion.
• Patent Expirations: The expiration of patents can lead to increased competition from generic versions, potentially reducing the market share of patented products.
• Side Effects and Safety Concerns: While rare, side effects such as eye irritation and changes in eye color can deter some potential users[1][3].

Financial Performance of Key Companies

Companies like Allergan, which markets Latisse, have reported significant financial performance:

• Revenue Growth: Allergan reported a 3% increase in GAAP net revenues in the first quarter of 2018, reaching $3.672 billion[2].
• Operating Income: Non-GAAP adjusted operating income from continuing operations showed an 8.7% increase in the same period[2].
• Full-Year Performance: For the full year 2019, Allergan reported total net revenues of $16.088 billion, with non-GAAP operating income of $7.314 billion[5].

Technological Trends and Innovations

The market is driven by technological advancements:

• New Formulations: Research into new formulations and delivery systems, such as implants, is enhancing the efficacy and convenience of Bimatoprost.
• Combination Therapies: Studies on combination therapies involving Bimatoprost and other drugs are ongoing, which could expand its therapeutic applications[4].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the market dynamics:

• Awareness and Education: Increased awareness about ocular health and the benefits of Bimatoprost drives consumer demand.
• Cosmetic Trends: The growing demand for cosmetic treatments, particularly for eyelash growth, influences market growth positively[1].

COVID-19 Impact

The COVID-19 pandemic had a mixed impact on the Latisse (Bimatoprost) market:

• Healthcare Prioritization: During the pandemic, there was a shift in healthcare priorities, which might have temporarily reduced non-essential cosmetic treatments.
• Telemedicine and Online Sales: However, the increased use of telemedicine and online sales channels helped maintain market stability to some extent[1][3].

Market Attractiveness and Competitive Landscape

The market attractiveness is high due to its growing demand and the presence of strong competitors:

• Competitor Analysis: The competitive landscape is characterized by intense competition among key players, with strategies focusing on product portfolio expansion and technological innovation.
• Market Attractiveness: The market's attractiveness is further enhanced by its potential for growth in emerging regions and the increasing demand for ophthalmic and cosmetic treatments[1][4].

SWOT Analysis

Strengths

• Established Brand: Latisse is a well-established brand with a strong market presence.
• Diverse Applications: It has multiple therapeutic and cosmetic applications.
• Technological Advancements: Continuous innovation in formulations and delivery systems.

Weaknesses

• Regulatory Challenges: Strict regulatory requirements can hinder market expansion.
• Patent Expirations: Expiration of patents can lead to increased competition from generics.

Opportunities

• Growing Demand: Increasing prevalence of ocular conditions and cosmetic treatments.
• Emerging Markets: Potential for growth in emerging regions.

Threats

• Competition: Intense competition from other ophthalmic and cosmetic treatments.
• Side Effects: Potential side effects can deter users[1][3].

Key Takeaways

• The global Latisse (Bimatoprost) market is experiencing significant growth driven by its therapeutic and cosmetic applications.
• North America dominates the market due to high demand and advanced healthcare infrastructure.
• Key players like Cayman Pharma and TCS Group are focusing on expanding their product portfolios and technological innovations.
• The market faces challenges such as regulatory hurdles and patent expirations but is driven by technological trends and increasing consumer awareness.

FAQs

What is Latisse (Bimatoprost) used for?

Latisse (Bimatoprost) is used to treat ocular hypertension, glaucoma, and eyelash hypotrichosis (sparse eyelash growth).

Which region dominates the Latisse (Bimatoprost) market?

North America is the largest market for Latisse (Bimatoprost), holding approximately 90% of the global share.

Who are the main players in the Latisse (Bimatoprost) market?

The main players include Cayman Pharma, TCS Group, Tecoland Corporation, Changzhou BOHIV, and others.

What are the key drivers of the Latisse (Bimatoprost) market?

Key drivers include the increasing prevalence of ocular conditions, cosmetic applications, and technological advancements.

How has the COVID-19 pandemic affected the Latisse (Bimatoprost) market?

The pandemic had a mixed impact, with temporary reductions in non-essential cosmetic treatments but also increased use of telemedicine and online sales channels.

Sources

1. Cognitivemarketresearch.com: Latisse Bimatoprost Market Report 2024 (Global Edition)
2. Allergan News: Allergan Reports 3% Increase in First Quarter 2018 GAAP Net Revenues
3. Cognitivemarketresearch.com: Global Latisse Bimatoprost CAS 155206 00 1 Market Report 2024
4. OpenPR: Latisse (Bimatoprost) Market 2024 Research Report
5. PR Newswire: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results