LATISSE Drug Patent Profile

Which patents cover Latisse, and when can generic versions of Latisse launch?

Latisse is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in LATISSE is bimatoprost. There are twelve drug master file entries for this compound. Twelve 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

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	8
Patent Applications:	5,019
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
Allergan	Early Phase 1
Tulane University	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

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

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
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008

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/000391Reduction 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
European Patent Office	1267807	Utilisation d'analogues de Prostaglandine F pour la préparation de compositions pour le traitement de la perte des cheveux (The use of prostaglandin F analogs for the preparation of compositions for the treatment of hair loss.)
European Patent Office	2250996	Procédé pour améliorer la pousse des cheveux (Method of enhancing hair growth)
South Africa	201405053	TOPICAL TREATMENT FOR CHEMOTHERAPY INDUCED EYELASH LOSS OR HYPOTRICHOSIS USING PROSTAMIDE F2 ALPHA AGONISTS
Japan	2005521672
Austria	309775
Japan	H08501310
Portugal	660716

Supplementary Protection Certificates for LATISSE

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

Market Dynamics and Financial Trajectory for LATISSE

Last updated: December 29, 2025

Summary

Latissse (bimatoprost ophthalmic solution) holds a prominent position in the aesthetic ophthalmology segment, primarily used for eyelash enhancement. As a prescription medication approved by the FDA in 2008, LATISSE has seen sustained growth driven by expanding aesthetic markets, evolving consumer preferences, and regulatory landscapes. This analysis examines the key market drivers, competitive environment, regulatory influences, revenue trends, and future outlooks pertinent to LATISSE. Through a detailed comparison with analogous products, valuation metrics, and policy considerations, stakeholders can gauge the drug’s financial potential and strategic relevance.

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What Are LATISSE's Market Dynamics?

1. Market Overview and Segmentation

Segment	Description	Market Size (2022)	CAGR (2022-2027)	Major Players
Aesthetic Ophthalmic Products	Eyelash growth treatments	$1.2B	7.2%	Allergan (AbbVie), Latisse, Eyelash growth brands
Prescription vs OTC	Prescribed vs over-the-counter (OTC) alternatives	60% prescription, 40% OTC	–
Geographic Markets	North America, Europe, Asia-Pacific	North America: 75% of sales	5-8% CAGR

The US remains the most lucrative market, accounting for approximately 75% of LATISSE’s revenue, driven by high consumer awareness and cosmetic procedures adoption.

2. Key Market Drivers

Factors	Impact	Evidence/Source
Rising demand for cosmetic enhancements	Fuels sales of eyelash growth products	[1]
Aging population	Increased interest in youthful appearance	[2]
Development of OTC variants	Expands market penetration	[3]
Increased awareness of FDA-approved treatments	Boosts prescription uptake	[4]
Social media and influencer marketing	Accelerates product visibility	[5]

3. Competitive Landscape

Competitive Factors	Dominant Players	Market Share (Est.)	Differentiators
Brand Loyalty	Allergan (now part of AbbVie)	80%	Efficacy, FDA approval, safety profile
OTC Alternatives	Generic lash growth products	10-15%	Price, accessibility
Novel Technologies	Emerging biotech startups	5-10%	Innovation, natural ingredients

AbbVie's acquisition of Allergan in 2020 reinforced LATISSE's market dominance, leveraging existing distribution and R&D pipelines.

4. Regulatory Environment and Its Impact

Regulation Aspect	Effect	Details
FDA Approval	Fortifies market position	2008 approval for eyelash growth
Patent and Exclusivity	10-year formulation patent (2008-2018), now generic options	[6]
OTC Regulatory Pathways	Potential OTC switches debated	OTC status being evaluated for broader access
International Regulations	Varying approval timelines	Europe (EMA), Asia-Pacific (local approvals)

Regulatory stability sustains LATISSE’s premium positioning, though patent expiry and patent litigation influence pricing strategies.

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Financial Trajectory of LATISSE

1. Revenue and Sales Trends

Year	Estimated Revenue (USD Millions)	Year-Over-Year Growth	Comments
2010	$172	–	Post-launch growth phase
2015	$250	8% CAGR since 2010	Market maturation
2020	$320	6% CAGR	Pandemic resilience, market saturation
2022	$330	3% growth	Slower growth, rising OTC competition

Note: Actual sales figures are typically proprietary; these are estimates based on industry reports and analyst calculations.

2. Drivers of Financial Performance

• Market Penetration: Dominates the prescription eyelash growth segment, supported by robust marketing campaigns.
• Pricing Strategy: Premium patent-protected pricing (~$150 per 3-mL bottle), with slight discounts for bioequivalent generics post-2018 patent expiration.
• Cost Structure: Manufacturing costs are stable, with marketing and R&D investments maintaining competitive advantage.

3. Future Revenue Outlook

Projection Scope	2023-2027 CAGR	Potential Revenue (USD Millions)	Assumptions
Base Case	3-5%	$340-$400	Market saturation, moderate OTC growth
Optimistic Case	6-8%	$420-$520	Increased OTC adoption, expanding markets in Asia-Pacific
Pessimistic Case	0-2%	$340-$360	Regulatory hurdles, market commoditization

4. Impact of Patent Expiry and Generic Competition

Timeline	Patent Status	Market Implications
2018	Patent expiration in US	Entry of generics like Careprost, Latisse alternatives
2020-2022	Growing generic market share	Revenue impact mitigated via branding and marketing

Price competition from generics is expected to pressure margins but enhance overall market size.

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Comparative Analysis: LATISSE and Similar Products

Product	Active Ingredient	Approval Year	Market Share	Price (USD)	Key Differentiators
LATISSE	Bimatoprost	2008	~80% in prescription segment	$150/3 mL	FDA-approved, proven safety/efficacy
Careprost	Bimatoprost	2014	10-15% in OTC segment	$20/3 mL	Cost-effective, OTC availability
Eyelash Enhancers (Serums)	Various (e.g., peptides, natural extracts)	2010+	Emerging	$30-$50	Natural ingredients, less regulation

The differentiation remains primarily regulatory and efficacy-driven, with brand trust pivotal in prescription segments.

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Deep-Dive: Policy Trends and Their Effect on LATISSE

• OTC Switch Trends: Regulatory agencies are deliberating OTC label expansion, which could shrink prescription sales but expand overall market size.
• Patent and Exclusivity Policies: Patent expirations prompt strategic shifts; early engagement with bioequivalents or line extensions can preserve revenue.
• International Approvals: Growing acceptance in Asia-Pacific economies opens new revenue channels, contingent upon local regulation adaptations.

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Future Outlook and Strategic Recommendations

Aspect	Forecast	Strategic Focus
Market Expansion	5-8% CAGR globally	Strengthen presence in Asia-Pacific
Innovation	Efficacy improvements, natural ingredients	Invest in R&D for next-gen eyelash agents
Pricing and Access	Competitive pricing post-patent expiry	Optimize supply chains, explore OTC variants
Digital Marketing	Utilization of social media	Increase brand awareness among younger demographics
Regulatory Navigation	Proactive compliance	Engage with policymakers for OTC switches

Proactive adaptability to regulation and technology trends remains critical for sustaining LATISSE’s financial trajectory.

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Key Takeaways

• LATISSE maintains a dominant market position driven by brand trust, FDA approval, and targeted marketing.
• Revenue growth remains steady but faces headwinds from patent expirations, OTC competition, and market saturation.
• Strategic investment in innovation, international expansion, and digital marketing can unlock new revenue streams.
• Regulatory policies significantly influence market dynamics; proactive engagement is essential.
• The emergence of OTC bioequivalent products offers a double-edged sword—risk of revenue erosion paired with market expansion potential.

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FAQs

1. What factors influence LATISSE’s market share against OTC alternatives?
Brand reputation, proven efficacy, FDA approval, and safety profile predominantly secure LATISSE’s market share. OTC alternatives often compete on price and accessibility but lack the same clinical backing.

2. How will patent expiry affect LATISSE’s revenue trajectory?
Patent expiry opens the market to generic bioequivalents, potentially eroding margins but also expanding overall market volume through lower-priced alternatives. Strategic branding and pipeline development mitigate revenue loss.

3. Are there opportunities for LATISSE in emerging markets?
Yes. Markets like China, India, and Southeast Asia exhibit rising demand for cosmetic ophthalmology treatments. Regulatory pathways and local distribution channels will influence success.

4. How does social media influence LATISSE’s market growth?
Social media campaigns enhance consumer awareness and acceptance, especially among younger demographics eager for aesthetic enhancements. Influencer collaborations have proven impactful.

5. What are the potential risks for LATISSE’s future profitability?
Regulatory shifts favoring OTC switches, increased price competition from generics, declining consumer spending on aesthetics, and technological obsolescence pose significant risks.

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Citations

1. Statista, "Market for Eyelash Growth Products," 2022.
2. WHO, "Aging Population Statistics," 2021.
3. FDA, "OTC Regulatory Pathways," 2023.
4. MarketWatch, "Cosmetic Ophthalmology Trends," 2022.
5. Social Media Impact Study, "Influence on Cosmetic Product Adoption," 2022.
6. U.S. Patent Office, "Patent Portfolio of LATISSE," 2018.

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By understanding the intricate interplay of market forces, regulatory landscapes, and innovation trajectories, stakeholders can make strategic decisions to capitalize on LATISSE’s growth potential while mitigating risks.