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. Fifteen 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 SANDOZ on May 5^th, 2015.

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:	5,606
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

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	9,216,183
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,926,953
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,101,161
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	6,403,649
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	9,579,270
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	8,986,715
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369-001	Dec 24, 2008	7,388,029

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
Austria	209494
Australia	2272197
Australia	4852693
Australia	5792496
Australia	676492
Australia	693698
Canada	2144967	DERIVES 2-CYCLOALKYLIQUES OU ARYLALKYLIQUESNON ACIDES DE L'ACIDE CYCLOP ENTANEHEPTANOIQUE COMME AGENTS THERAPEUTIQUES (NON-ACIDIC CYCLOPENTANE HEPTANOIC ACID, 2-CYCLOALKYL OR ARYLALKYL DERIVATIVES AS THERAPEUTIC AGENTS)

Supplementary Protection Certificates for LATISSE

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

Last updated: July 24, 2026

TISSE (bimatoprost ophthalmic solution 0.03%) market dynamics and financial trajectory (US focus)
Executive summary: LATISSE is the branded, prescription-only bimatoprost 0.03% lash-growth product marketed for hypotrichosis of the eyelashes. It is the only FDA-approved prostaglandin analog specifically for eyelash hair growth, with long-lived exclusivity anchored by the original NDA and label exclusivity rather than ongoing blockbuster-style lifecycle expansion. In the US, financial trajectory is shaped less by FDA pathway acceleration and more by (1) competitive substitution pressure from OTC-adjacent cosmetic serums and non-U.S. bimatoprost products, (2) clinical and safety positioning relative to ocular adverse events, and (3) steady erosion of brand share over time as patient acquisition shifts to lower-cost alternatives. Net sales trends have remained modest versus major ophthalmology or endocrine blockbusters, reflecting a smaller treatable population and a discretionary-use buyer segment.

What drives LATISSE market dynamics vs eyelash growth alternatives?

LATISSE sits at the intersection of prescription ophthalmic pharmacology and cosmetic demand. Market movement is therefore driven by demand capture, channel economics, and risk-adjusted willingness to use a prostaglandin analog on the periocular area.

Key demand drivers

• Prescriber penetration and patient conversion: dermatology, ophthalmology, and cosmetic medicine practices drive initial uptake; follow-through depends on perceived efficacy and tolerability.
• Perceived value over time: LATISSE requires chronic-like use to maintain effect. Value perception depends on maintenance adherence and cost relative to alternatives.
• Safety communications: ocular surface comfort, iris pigmentation risk, and periocular hyperpigmentation influence whether patients persist.

Key supply and channel factors

• Distribution model: retail pharmacies vs specialty/medical channels impacts rebate intensity and patient access.
• Form factor and instructions: LATISSE use requires controlled application with provided applicators; adherence issues reduce effective conversion from prescription to sustained use.

Substitution threats

• OTC cosmetic lash serums: these do not replicate bimatoprost’s mechanism and typically claim conditioning or styling rather than drug-mediated growth; still, they cap price sensitivity.
• Non-US bimatoprost products: where available, lower-cost off-label or imported versions can create “shadow competition” even if not legally equivalent in the US.

How has LATISSE financial performance trended since launch?

LATISSE’s financial trajectory has followed the typical pattern of a single-asset, label-defined niche product: meaningful revenue at launch, followed by stabilization at a lower baseline as adoption matures and competitive substitution increases.

Revenue ceiling is defined by the treatable population

The addressable market is smaller than major chronic therapies because the indication is cosmetic and discretionary. Even among eligible patients, adoption depends on:

• willingness to use a prescription drug on eyelashes,
• comfort with prostaglandin-class risks,
• ability to pay and insurance coverage (often limited because it is not usually medically insured).

Sales are sensitive to adherence and maintenance use

LATISSE’s effect is not typically durable after discontinuation, so demand tracks maintenance behavior rather than one-time courses. That creates:

• churn risk if patients stop after a cosmetic milestone, and
• stable but slower growth if clinicians manage expectations and titrate adherence.

Pricing and gross-to-net dynamics

Niche brands usually face:

• increasing promotional pressure over time,
• higher net discounting as payer and channel behavior evolves,
• reimbursement constraints that pressure effective realized prices.

What is the Orange Book status of LATISSE and what does that imply for generic competition?

LATISSE is a prescription product with a well-defined active ingredient and concentration: bimatoprost, 0.03% ophthalmic solution. Generic entry in the US depends on:

• patent and exclusivity timelines,
• whether an ANDA filer can establish bioequivalence and navigate listed patents under the Orange Book.

Orange Book and exclusivity logic

For a product like LATISSE, generic risk rises when:

• listed patents tied to the NDA (composition, method, formulation, and/or use) expire or are cleared, and
• statutory exclusivity (if applicable) lapses, allowing ANDAs to proceed to potential approval.

What matters commercially

In a niche drug, even a single delayed settlement or exclusivity extension can materially affect brand revenue duration because total sales are not huge enough for rapid post-generic market absorption.

When does LATISSE lose exclusivity and what are the realistic generic entry risks?

Generic entry risk for LATISSE is typically evaluated at two levels:

1. Hard IP: expiration of Orange Book-listed patents (composition, formulation, or method-of-use).
2. Exclusivity: any remaining exclusivity that prevents ANDA approval.

Generic entry scenario framework

• Early-stage risk: if patents protecting the specific 0.03% solution or the labeled method are still active, ANDA approval can be delayed even if exclusivity lapses.
• Post-lapse risk: if patents expire first, generic approval becomes possible, but launch profitability depends on channel pricing and competition from non-drug alternatives.
• Settlement-driven delay: in niche markets, generic challengers often settle to manage litigation cost and preserve predictable launch timing.

What patents protect LATISSE and how do formulation or method-of-use claims affect challengers?

LATISSE’s competitive moat is not only the active ingredient but also how the NDA is protected around concentration and the labeled use.

Patent estate categories that typically matter

• Composition/formulation patents: specific concentration (0.03%), stabilizers, solvents, and stability-related claims.
• Method-of-use patents: clinical instructions tied to eyelash hypotrichosis endpoints and administration patterns.
• Device or kit claims (if present): application methods and controlled delivery systems.

Why these matter

Even if generic challengers can match bimatoprost identity, they must navigate:

• equivalence of formulation performance,
• patent coverage around how the drug is used for lash growth.

How does LATISSE compare with other prostaglandin analogs used off-label for eyelash growth?

Clinically, bimatoprost is a prostaglandin analog. Other prostaglandin analogs and related agents have been used off-label in practice for periocular hair changes, but LATISSE has the advantage of:

• FDA approval for the specific indication,
• established dosing and labeling,
• insurer-friendly documentation in cases where coverage exists for branded drug care pathways.

Commercial comparison

Even where off-label agents are cheaper, brand LATISSE retains share when:

• clinicians require labeled dosing consistency,
• patients prioritize prescription-grade predictability,
• safety monitoring and patient counseling are easier under a labeled regimen.

What biosimilar risk exists for LATISSE?

Biosimilar frameworks generally do not apply because LATISSE is a small-molecule drug (bimatoprost), not a biologic. Market competition instead comes through:

• ANDA generics (if patents/exclusivity allow),
• non-branded bimatoprost products and off-label substitutes,
• OTC conditioning serums.

What regulatory milestones and FDA actions affect LATISSE demand and labeling?

Demand is primarily a function of:

• label stability,
• safety updates that influence prescriber comfort,
• communication around adverse events.

Label-driven commercial implications

If labeling remains stable, the product can maintain:

• prescriber trust and repeat prescribing,
• patient counseling workflows.

If safety communications change, conversion and persistence can fall even without changes in the underlying mechanism.

Which companies market and distribute LATISSE and how does that shape channel economics?

The commercial trajectory reflects:

• brand-owner marketing priorities,
• pharmacy benefit and contracting strategies,
• specialty pharmacy presence where it improves access and reduces friction.

In niche dermatology-ophthalmology products, channel contracting can drive a large share of realized revenue via net pricing and rebate structure.

What patent litigation or settlements have influenced LATISSE launch timing for competitors?

LATISSE’s generic risk depends on whether there have been:

• Paragraph IV certifications tied to ANDA filings,
• litigations in the US under the Hatch-Waxman framework,
• settlements that delay launch.

For financial modeling, the key variable is whether brand owners obtained delayed approvals via settlements rather than only relying on expiration dates.

How is LATISSE positioned commercially versus cosmetic lash serums and devices?

LATISSE competes indirectly with non-pharmacologic alternatives:

Where LATISSE holds share

• patients seeking measurable growth rather than conditioning,
• clinicians providing medical-grade therapy,
• consumers with a history of OTC product dissatisfaction.

Where alternatives take share

• cost-sensitive buyers,
• patients unwilling to use a prescription on a periocular site,
• consumers influenced by social media “quick fix” aesthetics that do not require chronic maintenance.

How strong is the patent estate for LATISSE as a barrier to entry?

A “strong estate” for a niche Rx product typically means:

• multiple overlapping patents spanning composition, formulation, and method-of-use,
• long tail of device/instruction or concentration-specific claims,
• legal outcomes that delay generic approval beyond exclusivity expiration.

From a business perspective, that translates to:

• a more durable revenue line,
• fewer price cuts caused by early generic entry,
• less volatility in annual forecast ranges.

Key market metrics to track for LATISSE forecasting

For business planning, LATISSE’s trajectory is best tracked with metrics that map to adoption and persistence:

Metric	Why it matters for LATISSE
New prescriptions per month	Measures prescriber acquisition and patient demand
Refill rate and persistence	Measures maintenance behavior and churn
Net price (after rebates)	Captures channel contracting and competitive pressure
Pharmacy fill share by chain/setting	Captures access and distribution effectiveness
Safety-related label communications	Drives conversion and persistence changes

Key Takeaways

• LATISSE is a niche, label-defined Rx lash-growth product where market dynamics are driven by clinician adoption, patient persistence, and risk-adjusted willingness to use a prostaglandin analog on the periocular area.
• Financial performance is structurally constrained by a smaller addressable population and by the discretionary nature of cosmetic use.
• Competitive pressure comes more from substitution (OTC serums, non-US bimatoprost products, off-label alternatives) than from biosimilar competition.
• Generic entry timing and erosion of brand sales depend on the Orange Book patent and exclusivity profile, including any Hatch-Waxman litigation or settlements tied to ANDA filings.

FAQs

1. Is LATISSE covered by insurance and how does reimbursement affect sales?
2. What are the most common ocular or periocular adverse events that influence LATISSE discontinuation rates?
3. How do OTC lash serums compete with LATISSE on patient choice and price sensitivity?
4. What ANDA approval pathways would be required for generic bimatoprost 0.03% eyelash indication products?
5. How do prescriber specialty mix (dermatology vs ophthalmology) and refill behavior impact LATISSE forecasting?

References

No sources provided in the prompt.

DrugChatter Q&A for LATISSE

Allergan's patent for latisse expired?
When will latisse patent expire?
Generic brand for latisse?