COMBIGAN Drug Patent Profile

Which patents cover Combigan, and what generic alternatives are available?

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

The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Combigan

A generic version of COMBIGAN was approved as brimonidine tartrate; timolol maleate by SANDOZ on April 4^th, 2022.

Summary for COMBIGAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	22
Patent Applications:	83
Drug Prices:	Drug price information for COMBIGAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMBIGAN
What excipients (inactive ingredients) are in COMBIGAN?	COMBIGAN excipients list
DailyMed Link:	COMBIGAN at DailyMed

See drug prices for COMBIGAN

See drug sales revenues for COMBIGAN

Recent Clinical Trials for COMBIGAN

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

Sponsor	Phase
Hanlim Pharm. Co., Ltd.	Phase 4
CHA University	Phase 4
Salus University	Phase 4

See all COMBIGAN clinical trials

Pharmacology for COMBIGAN

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for COMBIGAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIGAN	Ophthalmic Solution	brimonidine tartrate; timolol maleate	0.2%/0.5%	021398	1	2008-11-21

US Patents and Regulatory Information for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007	AB	RX	Yes	Yes

Expired US Patents for COMBIGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

International Patents for COMBIGAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003228480	COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE
Brazil	0302584	Combinação de brimonidina e timolol para uso oftálmico tópico
Canada	2440764	COMBINAISON DE BRIMONIDINE ET DE TIMOLOL POUR UTILISATION TOPIQUE OPHTALMIQUE (COMBINATION OF BRIMONIDINE AND TIMOLOL FOR TOPICAL OPHTHALMIC USE)
China	100558364
China	101664414	Combination of brimonidine and timolol for topical ophthalmic use
China	112219061	带有声音抑制的悬挂式垂饰光导灯具 (SUSPENDED PENDANT LIGHTGUIDE LUMINAIRE WITH SOUND DAMPENING)

Supplementary Protection Certificates for COMBIGAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	C300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221

COMBIGAN (brimonidine tartrate + timolol maleate ophthalmic solution): Market dynamics and financial trajectory

Last updated: April 25, 2026

What is COMBIGAN’s market role and competitive context?

COMBIGAN is an ophthalmic fixed-dose combination for lowering intraocular pressure (IOP) in glaucoma and ocular hypertension. The product is positioned in the “drops” segment, where brand incumbents face ongoing pressure from generics and from competing branded combination regimens that target adherence and dosing convenience.

Key product attributes shaping demand

• Indication set: glaucoma and ocular hypertension (IOP lowering).
• Formulation class: ophthalmic solution; combination of an alpha-2 agonist (brimonidine) and a beta-blocker (timolol).
• Clinical value proposition: fixed-dose combination to reduce treatment complexity versus using separate agents.

Competitive forces that typically determine share in fixed-dose glaucoma drops

1. Generic substitution risk
   • When patents and exclusivities fall away, pricing pressure from approved generics usually drives volume-to-value decline.
2. Brand competition in combination regimens
   • Competitors with fixed-dose approaches compete on convenience and tolerability.
3. Formulary and payer controls
   • Glaucoma drug coverage is heavily influenced by step therapy and preferred-drug lists, which can compress net prices even without generic entry.

Demand sensitivity by market structure

• Chronic use and adherence dependence: IOP control requires ongoing dosing; persistence matters for net sales.
• Switching friction: Once patients stabilize on a regimen, switching is less frequent unless payer policies force changes.

What are the historical market dynamics for COMBIGAN sales momentum?

COMBIGAN’s financial trajectory follows a standard lifecycle pattern for branded ophthalmic products: early growth and share building, then gradual erosion from generic penetration and payer-driven channel tightening. Without a controlled data feed of COMBIGAN’s exact annual revenue and unit sales by geography, the only defensible way to characterize “trajectory” is through lifecycle mechanics tied to regulatory status and market events affecting exclusivity and competitive pricing.

Observable lifecycle mechanics that drive COMBIGAN’s market dynamics

• Exclusivity window ends, then generics expand
  • After brand exclusivity expires, generics with equivalent active ingredients typically enter and force net price resets.
• Net sales compress even if unit sales remain
  • Net sales can fall faster than volumes when rebates and payer pricing tighten post-generic entry.
• Line extensions and alternative formulations affect mix
  • Competitors may win share by offering alternative dosing strengths, preservative systems, or different combination pairings.

How do patent and regulatory milestones translate into financial outcomes for COMBIGAN?

For an ophthalmic combination like COMBIGAN, financial outcomes are usually determined by:

• Patent expiration and exclusivity end dates
• Generic entry timing
• Regulatory and litigation timelines that can delay or accelerate market entry

Typical linkage from milestone to revenue impact

• Anticipation effect: Channel inventory and payer planning often pressure net sales in the months leading to expiry.
• Entry shock: Generic launch generally causes immediate price compression.
• Catch-up period: Over 6 to 24 months, net sales settle based on contracted rebate levels and payer conversions.

Practical implication for budgeting and forecasting

• Model COMBIGAN with two phases
  • Phase 1: branded pricing power (before generic penetration becomes material).
  • Phase 2: structural net price decline from competitive switching and formulary pressure.

What does the financial trajectory usually look like in the glaucoma drop segment after generic erosion?

Even when the underlying clinical need remains constant, the financial trajectory of a branded glaucoma drop is shaped by economics of ophthalmic retail and payer contracting.

Post-generic financial pattern

• Gross-to-net deterioration
  • Rebate levels rise to defend share; pricing becomes more “contracted” and less brand-premium.
• Unit elasticity but value contraction
  • Some patients stay on product for tolerability or familiarity, but volume does not fully offset price compression.
• Higher volatility from formulary wins and losses
  • Small channel changes can swing revenue because the category is competitive.

Where COMBIGAN typically fits on that pattern

COMBIGAN’s combination profile makes it a target for generics only to the extent that the underlying actives are patent-expired. Once generics are established for brimonidine/timolol combination products, COMBIGAN’s net sales face persistent downward pressure.

What are the key market drivers and headwinds affecting COMBIGAN going forward?

Market drivers

• Chronic IOP lowering demand
  • Glaucoma is a long-duration condition, which supports baseline demand for effective regimens.
• Combination convenience
  • Fixed dosing can reduce treatment burden versus multi-drug regimens.

Headwinds

• Ongoing generic and authorized generic competition
  • The glaucoma drop space is among the more mature segments for substitution.
• Payer step therapy and preference lists
  • Coverage decisions can rapidly redirect new prescriptions.
• Switching risk
  • Patients may move to lower-cost alternatives after coverage pressure.

How should an investor or planner view COMBIGAN’s financial trajectory for decision-making?

A decision-grade framing is to treat COMBIGAN as:

• A mature ophthalmic franchise subject to price erosion, with
• Potential for limited volume retention tied to tolerability and switching friction.

Scenario logic (business-ready)

• If generic penetration is already material: expect net sales to trend down with occasional quarter-to-quarter volatility from formulary changes.
• If channel defense persists: volume decline may be slower than net price decline, leading to a gradually worsening margin profile.
• If new competition intensifies: net sales decline accelerates as payer lists refresh.

What KPIs should be tracked to monitor COMBIGAN’s trajectory?

Because the glaucoma drop market is payer- and channel-driven, the most actionable KPIs typically include:

• Rx share by payer tier
• Average net price trajectory
• Generic penetration rate in the combination space
• Persistence rates (stay on therapy)
• Inventory channel indicators around key market events

Is COMBIGAN expanding, stable, or shrinking by market share dynamics?

Given the expected lifecycle position of a branded fixed-dose ophthalmic combination in a mature category, COMBIGAN’s dynamics are typically characterized by:

• Share pressure from generics
• Constrained upside unless differentiated on formulary terms or clinical differentiation
• Net sales trending down in the long run even if absolute patient need persists

Key Takeaways

• COMBIGAN competes in a mature glaucoma drops category where generic penetration and payer contracting drive long-run financial compression.
• The most consistent financial pattern for branded glaucoma eye drops after exclusivity erosion is net price decline that outpaces unit retention, producing structural revenue downtrends.
• Forward performance hinges less on clinical demand and more on payer formulary status, rebate pressure, and generic/authorized generic intensity in the brimonidine/timolol combination space.
• Management and investment decisions should focus on net price trajectory, Rx share by payer tier, generic penetration, and persistence, not just prescription starts.

FAQs

1. What is COMBIGAN’s therapeutic category?
   It is a fixed-dose ophthalmic combination of brimonidine tartrate and timolol maleate used to lower intraocular pressure in glaucoma and ocular hypertension.

2. What market factor most strongly drives branded glaucoma drop sales after exclusivity?
   Payer contracting and generic substitution, which compress net price and reduce formulary preference.

3. Why can unit volume decline less than revenue after generic entry?
   Because branded products may retain some patients initially, but net pricing and rebates typically deteriorate faster than volumes.

4. What KPIs best predict COMBIGAN’s near-term financial trajectory?
   Net price, Rx share by payer tier, generic penetration in the combination segment, and persistence on therapy.

5. Does ongoing patient need protect COMBIGAN revenue?
   It supports baseline demand, but in mature markets financial outcomes still trend downward once pricing power is lost to competition.

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References

[1] COMBIGAN. FDA Label (U.S. prescribing information). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/

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