PATADAY ONCE DAILY RELIEF Drug Patent Profile

Which patents cover Pataday Once Daily Relief, and when can generic versions of Pataday Once Daily Relief launch?

Pataday Once Daily Relief is a drug marketed by Alcon Labs Inc and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in PATADAY ONCE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pataday Once Daily Relief

A generic version of PATADAY ONCE DAILY RELIEF was approved as olopatadine hydrochloride by APOTEX INC on October 8^th, 2014.

Summary for PATADAY ONCE DAILY RELIEF

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	7
Patent Applications:	2,014
What excipients (inactive ingredients) are in PATADAY ONCE DAILY RELIEF?	PATADAY ONCE DAILY RELIEF excipients list
DailyMed Link:	PATADAY ONCE DAILY RELIEF at DailyMed

Recent Clinical Trials for PATADAY ONCE DAILY RELIEF

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Allergan	Phase 4
McCabe Vision Center	N/A

See all PATADAY ONCE DAILY RELIEF clinical trials

Pharmacology for PATADAY ONCE DAILY RELIEF

Drug Class	Histamine-1 Receptor Antagonist Histamine-1 Receptor Inhibitor Mast Cell Stabilizer
Mechanism of Action	Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Paragraph IV (Patent) Challenges for PATADAY ONCE DAILY RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.7%	206276	1	2015-09-10
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.2%	021545	1	2008-09-08

US Patents and Regulatory Information for PATADAY ONCE DAILY RELIEF

PATADAY ONCE DAILY RELIEF 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
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004		OTC	Yes	Yes
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	8,791,154		Y
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	9,533,053		Y

International Patents for PATADAY ONCE DAILY RELIEF

See the table below for patents covering PATADAY ONCE DAILY RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1337603	DERIVE DE DIBENZ[B,E] OXEPINE ET AGENT ANTIALLERGIQUE ET ANTIINFLAMMATOIRE (DIBENZ[B,E]OXEPIN DERIVATIVE AND ANTIALLERGIC AND ANTIINFLAMMATORY AGENT)
Germany	3778734
European Patent Office	0235796	DIBENZ (B,E) OXEPIN DERIVATIVE AND ANTIALLERGIC AND ANTIINFLAMMATORY AGENT
Spain	2038608
Hong Kong	68996	Dibenz (b,e) oxepin derivative and antiallergic and antiinflammatory agent
Japan	H0586925

Supplementary Protection Certificates for PATADAY ONCE DAILY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
0799044	SPC029/2002	Ireland		SPC029/2002: 20040930, EXPIRES: 20170516
0799044	CA 2002 00029	Denmark
0799044	SPC/GB02/041	United Kingdom		SPC/GB02/041: 20021018
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203

Last updated: June 11, 2026

Pataday Once Daily Relief (olopatadine ophthalmic solution) Market Dynamics and Financial Trajectory: Sales Trends, Brand Positioning, and Loss-of-Exclusivity Drivers

Pataday Once Daily Relief (olopatadine ophthalmic solution, once-daily) is an established allergy eye-drop brand in the U.S., competing in a mature OTC and prescription-adjacent antihistamine/anti-inflammatory ophthalmic class. Market outcomes track closely with (1) the pace of generic/authorized-generic penetration after patent and regulatory exclusivity gaps, (2) channel substitution versus ketotifen, olopatadine BID products, and other antihistamine/mast-cell stabilizers, and (3) any formulary or payer dynamics that influence prescription vs self-pay mix.

What is the current U.S. market position for Pataday Once Daily Relief?

Direct answer: Pataday once-daily is a leading branded olopatadine line extension within allergic conjunctivitis, with demand supported by differentiation versus older multi-dose antihistamines and by once-daily convenience.

Therapeutic category and competitive set

• Indication: allergic conjunctivitis (itching dominant symptom; antihistamine effect with additional anti-inflammatory activity).
• Comparable alternatives:
  • Other antihistamine/mast-cell stabilizers: ketotifen (various dosing), olopatadine BID (same active), and related agents depending on formulation.
  • Dual-mechanism options: antihistamine plus mast-cell stabilization in different products.
  • OTC antihistamine eye drops where applicable, with substitution pressure on brand pricing.

Why once-daily matters commercially

• One dosing interval reduces patient adherence friction versus BID regimens.
• The value proposition is typically strongest where mild-to-moderate allergy episodes persist across seasons and patients avoid complex schedules.

Channel dynamics that shape revenue

• Prescription channel vs OTC/self-pay can shift year to year based on:
  • patient cost sensitivity,
  • insurance formulary moves,
  • retailer promotional activity for competing eye drops,
  • and the entry timing of generics for the same dosing regimen.

How does Pataday Once Daily Relief compare with generic olopatadine and same-active competitors?

Direct answer: Same-active competitive pressure is usually the fastest revenue headwind because generic olopatadine can undercut brand pricing without changing therapeutic effect.

Key substitution vectors

• Same molecule, different label dosing:
  • Pataday Once Daily Relief competes against olopatadine products with different dosing frequency.
• Same mechanism, different molecule:
  • ketotifen and other antihistamine drops compete on adherence and price.
• Formulation and bottle/pack experience:
  • patients and prescribers often stay with familiar packaging and dosing simplicity, but price compression accelerates switch once generic penetration rises.

Commercial implication for brand pricing

• Once generics become widely available, brands typically shift from volume growth to trade-spend management and contract retention.
• Brand revenue trajectory usually tracks a step-down pattern: pre- and early-generic period, then sustained decline with slower attrition once the market stabilizes.

When does Pataday Once Daily Relief lose exclusivity and face generic entry risk?

Direct answer: The exclusivity and generic entry timeline depends on which patent families cover the specific once-daily formulation, strength, and method-of-use claims, and on whether any listed FDA exclusivities (and patent expirations) are still in force.

Exclusivity and patent estate typically determine the financial cliff

For ophthalmic formulations, the revenue cliff often aligns with:

• expiration of patents covering the once-daily composition and/or method-of-use,
• expiration of any pediatric exclusivity or other statutory exclusivity tied to the NDA/BLA,
• and the ability of ANDA filers to launch when Orange Book-listed patents are cleared through expiry or Paragraph IV litigation.

Market translation

• At launch, the brand’s effective net sales usually compress quickly due to:
  • pharmacy switch behavior,
  • payer formulary updates,
  • and wholesaler replenishment cycles.

(Note: Specific Orange Book patent numbers, expiration dates, and Paragraph IV milestones are not provided in the available input; this section therefore cannot be completed with hard dates.)

What Orange Book status applies to Pataday Once Daily Relief, and what patents are typically listed?

Direct answer: The Orange Book lists patents for the approved drug product, including composition and method-of-use related to allergic conjunctivitis efficacy.

What to expect in an Orange Book listing for an ophthalmic antihistamine

• Composition-of-matter and/or composition claims tied to:
  • the once-daily formulation,
  • concentration/strength,
  • and stability-related components.
• Method-of-use claims tied to:
  • treating allergic conjunctivitis,
  • dosing regimens (once daily).

How listings shape generic timing

• ANDA filers can be blocked until:
  • listed patents expire,
  • or litigation results in a judgment or settlement permitting launch before full expiry.

(Hard Orange Book listings and patent identifiers are not available in the provided input, so this cannot be populated with patent-level data.)

What patent litigation and Paragraph IV challenges affect Pataday Once Daily Relief generics?

Direct answer: Paragraph IV challenges determine whether generic entry occurs at the earliest possible date or is delayed by litigation or settlements.

Financial relevance of litigation outcomes

• If a court rules for the brand, entry can be pushed beyond the earliest date, protecting brand net sales for additional quarters/years.
• If a settlement allows early entry at a defined date, the brand faces a predictable revenue drop aligned to that launch date.

(No litigation docket or settlement dates are supplied in the input; this section cannot be completed with case-level details.)

What formulations and strengths are commercially most relevant for Pataday Once Daily Relief?

Direct answer: Commercial performance generally concentrates on the labeled once-daily strengths and bottle formats used for pharmacy and channel distribution, with pull-through influenced by seasonality and patient preference.

Formulation factors that influence uptake

• Dosing convenience (once-daily).
• Drop comfort and tolerability.
• Packaging usability and patient handling.

How formulation protection drives pricing

• If the once-daily formulation is protected against generic substitution (through patent coverage), brand revenue can remain more resilient.
• After generic approval, pricing typically moves toward class-competitive levels, reducing brand gross margin and net sales.

How does Pataday Once Daily Relief revenue typically trend over the product lifecycle?

Direct answer: In mature ophthalmic allergy categories, branded once-daily products typically show:

1. growth or steady-state before generic entry,
2. a sharp decline in the first year after widespread generic availability,
3. then a slower decline or stabilization as the market standardizes.

Seasonality effects

• Allergic conjunctivitis demand is seasonal, driving quarterly volatility.
• Financial reports usually show stronger spring and summer performance, with weaker winter and off-season demand.

Channel shift effects

• OTC expansion or increased retailer promotions for competing drops can shift mix.
• Prescription brand demand can be sensitive to formulary actions, impacting net sales even before generic entry.

What commercial metrics matter most for Pataday once daily performance?

Direct answer: The leading indicators are net sales at NDC level, prescription-to-OTC mix, pharmacy buy-in behavior post-generic entry, and trade spend levels.

Primary business KPIs

• Net sales by channel (retail vs specialty, depending on how the drug is dispensed).
• Unit share versus competitors (olopatadine BID, ketotifen, other antihistamine drops).
• Gross margin and net price erosion after generic launches.
• Promotion and trade spending intensity in the allergy season.

What investors and licensing teams monitor

• Whether the brand maintains share after generic entry (less common without differentiated formulation or contract retainers).
• Whether alternative products under the same manufacturer cannibalize or protect the portfolio.

How does Pataday Once Daily Relief compete against other antihistamine eye drops on adherence and dosing?

Direct answer: Competitive advantage is adherence driven. Once-daily dosing reduces regimen burden, which typically supports higher persistence than BID alternatives, especially for patients managing seasonal flares.

Mechanism-level competition

• Multiple antihistamines share the symptomatic itch relief goal.
• Differentiation is often incremental and depends on:
  • formulation comfort,
  • speed of onset for subjective itching relief,
  • and patient-reported tolerability.

How do manufacturing and IP barriers affect generic entry for Pataday Once Daily Relief?

Direct answer: For ophthalmics, generic entry barriers are typically legal (Orange Book patents and litigation) and regulatory (bioequivalence and formulation compliance), rather than manufacturing complexity alone.

Typical barriers that delay entry

• Patent coverage requiring carve-outs or design-around approaches for method-of-use claims.
• Stability requirements tied to excipients in once-daily formulations.
• Product-specific device or dropper/packaging considerations that can affect formulation equivalence.

(Specific manufacturing/IP barriers are not provided in the input, so this remains category-level.)

What are the most likely “loss-of-exclusivity” scenarios for Pataday Once Daily Relief?

Direct answer: The most likely scenarios are:

• scheduled patent expiry prompting ANDA launches at or near expiry,
• delayed entry due to Paragraph IV litigation or settlement,
• and post-launch price erosion resulting from multiple generic filers.

Scenario mapping to financial trajectory

• Early entry permitted by settlement: faster revenue step-down.
• Full litigation delay: extended branded protection, pushing revenue decline later.
• Single generic entrant vs multiple entrants: affects magnitude of net price compression and share loss pace.

Key takeaways

• Pataday Once Daily Relief sits in a mature allergic conjunctivitis market where once-daily convenience supports demand through the seasonality cycle.
• Same-active generic olopatadine and same-mechanism antihistamine eye drops are the principal competitive threats, typically driving net price erosion after exclusivity gaps.
• The financial trajectory is usually dominated by the timing of patent expiry, Orange Book clearing, and any Paragraph IV litigation settlements that set launch dates.
• Revenue monitoring should focus on NDC-level net sales, channel mix shifts, trade spend intensity, and unit share relative to olopatadine BID and ketotifen class alternatives.

FAQs

1) What drives Pataday Once Daily Relief sales seasonality?
Allergic conjunctivitis incidence and patient symptom cycles concentrate demand into spring and summer.

2) Do prescribers switch patients from Pataday once daily to generic olopatadine?
Switching accelerates when generics become widely available and pharmacy pricing incentives align, especially as adherence requirements remain similar.

3) What is the main financial risk to Pataday once daily after exclusivity ends?
Net price compression and share loss after generic launches, compounded by trade-spend pressure to retain contracts.

4) How do settlements in Paragraph IV cases change brand revenue timing?
Settlements can shift the launch date earlier or later than the first possible expiry date, creating a predictable step-down in net sales at entry.

5) Which competitive products most threaten long-term brand share?
Same-active olopatadine products with alternative dosing regimens and widely stocked antihistamine/mast-cell stabilizer eye drops, especially ketotifen formulations where available.

References

(No sources were provided in the input, and no drug-specific patent/Orange Book/litigation datasets were included. No citations can be generated without source material.)