CLARITIN Drug Patent Profile

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

Claritin is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs.

The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Claritin

A generic version of CLARITIN was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30^th, 2003.

Summary for CLARITIN

US Patents:	0
Applicants:	1
NDAs:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	27
Patent Applications:	4,282
Drug Sales Revenues:	Drug sales revenues for CLARITIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARITIN
What excipients (inactive ingredients) are in CLARITIN?	CLARITIN excipients list
DailyMed Link:	CLARITIN at DailyMed

See drug sales revenues for CLARITIN

Recent Clinical Trials for CLARITIN

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Rutgers, The State University of New Jersey	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CLARITIN clinical trials

US Patents and Regulatory Information for CLARITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	CAPSULE;ORAL	021952-001	Jun 16, 2008		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-003	Nov 19, 2003		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021993-001	Dec 12, 2006		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET, CHEWABLE;ORAL	021891-002	Nov 21, 2018		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	TABLET;ORAL	019658-003	Nov 19, 2003		OTC	Yes	Yes

Expired US Patents for CLARITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002

International Patents for CLARITIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	9695
Australia	543054
Australia	7186281
Canada	1160230	ANTIHISTAMINIQUE (ANTIHISTAMINES)
Cyprus	1405	NOVEL ANTIHISTAMINES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Germany	3166441
Denmark	169817

Supplementary Protection Certificates for CLARITIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897	SPC/GB01/012	United Kingdom		PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115

CLARITIN (Loratadine) Market Dynamics and Financial Trajectory: Pricing, Share, Generics, and Exclusivity Fallout

Last updated: July 20, 2026

CLARITIN (loratadine) is a largely genericized antihistamine in the US, with long-run revenue driven by OTC channel strength, periodic re-formulation/pack-size refreshes, and branded nostalgia pricing rather than active exclusivity. Post-patent cliff dynamics in the US are defined by: (1) low-cost generic entry in tablet and syrup, (2) OTC retail price compression, and (3) share concentration among major mass-market and pharmacy retailers. Internationally, brand persistence depends on local filing/pack rules and the pace of generic substitution.

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How has CLARITIN’s US market evolved after generic entry?

What portion of CLARITIN is now “branded vs generic” in the US

CLARITIN’s active ingredient, loratadine, has been widely available as generics in standard strengths (typically 10 mg tablets; liquid/syrup forms). In mature OTC categories, branded capture usually shifts from volume share to revenue value capture via price premium and better shelf placement for specific SKUs (caplets, tablets, rediTabs-type formats, and child-friendly liquids).

What drives OTC loratadine pricing in mature markets

1. Retail price compression from multigeneric competition. Once multiple ANDA-labeled products are established, base unit pricing converges toward the lowest-cost equivalent, with brand premiums limited by retailer and consumer price sensitivity.
2. Channel-specific pricing behavior. Big-box and pharmacy chains tend to run aggressive private label and store-brand substitutions around peak seasonal demand.
3. SKU-level resilience. Brand survivability is often highest where pack configuration and perceived convenience differentiate (caplet formats, specific dosing instructions, and consistent OTC merchandising).

Seasonality and working-capital cycle

Loratadine demand is seasonal, with a retail pull-through pattern that typically peaks ahead of and during spring allergy months. That means:

• Inventory build occurs in advance of peak weather-driven demand.
• Revenue exhibits quarters with stronger OTC sell-in and weaker trough quarters once allergy season ends.

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What are the key financial trajectory signals for CLARITIN (revenue and growth)?

How a mature OTC antihistamine usually behaves financially

For a genericized OTC antihistamine:

• Net revenue growth is limited and tends to track inflation, pack price changes, and minor mix shifts rather than unit growth.
• Gross margin compresses when brands lose price premium to generics or when wholesalers tighten discounting during competitive periods.
• Promotional intensity increases post-generic entry, because retailers negotiate margin and shelf-space.

Where growth can still come from

Even under generic pressure, CLARITIN-like brands can show modest revenue resilience through:

• Assortment expansion (new package sizes, child formulations, and convenience SKUs).
• Seasonal marketing and retailer programs that protect shelf share.
• Therapeutic cross-use (non-seasonal use cases like chronic allergic symptoms) that smooth demand versus purely spring-only products.

Financial inflection periods to watch

• Generic launch windows: the strongest declines usually follow the first meaningful multi-generic availability rather than the earliest single entrant.
• OTC category shifts: new entrants or reformulated rivals can steal frequency, even if the underlying active ingredient is not directly replaceable.

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What patents protected CLARITIN (loratadine), and when did exclusivity end?

What patents matter for loratadine brand-to-generic transitions

For an older small-molecule OTC brand like CLARITIN, the business-critical items are:

• Composition-of-matter patents on loratadine.
• Formulation patents on specific dosage forms (tablets, syrups) and stability-enhanced variants.
• Method-of-manufacture patents affecting process claims and sometimes downstream ANDA litigation strategy.
• Regulatory exclusivity is secondary for a mature OTC product compared with real patent estate timing.

Timeline framework for “when exclusivity ends”

In US branded-to-generic transitions for small molecules:

• Brand exclusivity ends when the last relevant patent (or enforceable patent) expires.
• Competitive entry is typically accelerated by Paragraph IV certifications where still-in-force patents are challenged.
• After generic entry, the branded revenue curve usually declines steeply then flattens as remaining brand premium becomes stable.

(No patent-expiration dates are included here because they require a specific Orange Book patent list and exact CLARITIN NDA labeling identifiers, which are not provided in the prompt.)

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What is the Orange Book status of CLARITIN loratadine?

How Orange Book listings typically map to OTC market outcomes

• If Orange Book lists only inactive or expired patents, the practical outcome is broad generic availability with minimal remaining blocking IP.
• If any unexpired patents remain on method or formulation, generics may be limited to specific dosage forms or strengths.

(Orange Book status cannot be enumerated without the specific NDA/labeler listing data.)

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How many patents cover CLARITIN formulations, and do they block specific generic dosage forms?

Patent estate characteristics that matter commercially

For OTC antihistamines, practical blocking tends to be:

• Dosage-form-specific: a formulation patent may protect tablets but not oral solution, or vice versa.
• Concentration-specific: pediatric liquid strengths can have different claim coverage and labeling.

Why “dosage form blocking” matters to financial trajectory

If generics enter only in tablets but not in liquid, the branded product can keep:

• A revenue floor in pediatric segments.
• Higher share in family households that buy a child liquid year-round.

(Patent coverage counts and claim-specific blocking cannot be stated without the Orange Book patent and claims list.)

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Which generic entrants most affected CLARITIN share and pricing?

What competitive patterns dominate

In mature loratadine markets, impact is usually from:

• Large, low-cost ANDA filers that scale distribution quickly.
• Retailer-preferred suppliers that win end-cap placements via pricing and service.
• Private label when retailers can source equivalent loratadine at materially lower unit cost.

Why early entrants may not “win”

A first wave of generics can still be outcompeted if later entrants offer:

• Better packaging compliance at lower landed cost.
• Stronger retailer trade deals that expand shelf presence.

(Entrant identities cannot be listed without specific ANDA approvals and labeler names.)

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What patent litigation affected CLARITIN, including Paragraph IV cases and settlements?

Typical litigation pathways for older OTC small molecules

• Paragraph IV challenges to Orange Book-listed patents.
• Settlements that define “design-around” entry dates or restrict certain dosage strengths, packaging, or manufacturing methods.

Commercial impact of settlements

• A settlement can delay generic entry in a narrow segment even if the broader market is generically available.
• The financial trajectory then shows slower erosion in the protected SKU group, with erosion accelerating once the settlement terms expire.

(No case names, dates, or docket outcomes are included because the prompt does not provide the Orange Book patent list or litigation docket identifiers.)

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Does CLARITIN face biosimilar risk or biologic-style exclusivity?

Why biosimilar dynamics do not apply

CLARITIN is a small-molecule antihistamine (loratadine). It is not a biologic product, so biosimilar exclusivity regimes do not apply.

Instead, the competitive framework is ANDA-driven generic substitution under Hatch-Waxman, plus OTC retail competition.

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How does CLARITIN compare with competing antihistamines on market dynamics?

Competes with other non-sedating antihistamines

The competitive set for OTC allergy management generally includes:

• Cetirizine (and branded combinations)
• Fexofenadine (and branded combinations)
• Levocetirizine

Business logic for consumer switching

Switching often follows:

• Side-effect profile perception (sleepiness risk)
• Price and pack value
• Form factor (caplets vs dissolvable tabs vs liquids)
• Perceived efficacy for specific symptom profiles

What this means for financial trajectory

If competitors hold stronger:

• Price position (lower unit cost),
• Retail program strength (rebates, shelf strategy),
• Or higher consumer affinity, CLARITIN’s value growth typically caps, even if absolute demand in OTC allergy care grows seasonally.

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Where does CLARITIN earn money today: OTC channel mix and SKU strategy

High-level channel drivers

1. Mass retail: greatest volume in peak season, strongest private label pressure.
2. Pharmacy: higher likelihood of brand premium if brand merchandising is maintained.
3. E-commerce: price transparency accelerates generic substitution unless brand trust drives repeat purchases.

SKU strategy that sustains revenue

Branded OTC strategies that commonly matter for mature antihistamines:

• Child-friendly liquid formats maintained through brand trust.
• Predictable dosing and packaging that supports repeat household purchases.
• Bundled or value pack offerings during allergy season.

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What generic entry risks exist for remaining CLARITIN formats?

Residual risks after broad loratadine generic availability

Even when the active ingredient is generic, risk remains at the SKU level:

• Liquid or pediatric formulations can have fewer suppliers or different formulation constraints.
• Labeling differences can affect switch speed.
• Supply chain readiness can delay share capture for specific strengths.

Financial consequence

If CLARITIN keeps a niche SKU with fewer equivalent competitors, the revenue decline may be less steep for that line while tablets fully commoditize.

(Specific format risk cannot be quantified without SKU-level product line data and corresponding ANDA approvals.)

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Key Takeaways

• CLARITIN’s market is in a mature OTC phase where financial outcomes are driven by genericized price competition, seasonality, and SKU/channel mix, not by active drug exclusivity.
• Revenue trajectory typically shows steep erosion after multi-generic availability, followed by flattening with modest growth supported by pack and assortment.
• Patent and litigation dynamics matter primarily in dosage-form-specific segments; broad loratadine commoditization usually dominates the overall brand curve.
• Competitive antihistamine switching is driven by consumer perception of sedation, price, and retailer program strength across peak allergy seasons.

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FAQs

Is CLARITIN still a branded product with meaningful exclusivity in the US?

For mature OTC loratadine, meaningful exclusivity is generally limited or absent at the active-ingredient level; any remaining brand advantage is usually SKU, distribution, and pricing rather than enforceable blocking patents.

What drives CLARITIN revenue differences between quarters?

Seasonal allergy demand creates stronger retail pull-through in spring/summer allergy periods and weaker performance in off-season quarters.

Will a new loratadine generic reduce CLARITIN pricing immediately?

In a commoditized OTC category, additional entrants typically accelerate price convergence, but retailer contract timing and supply dynamics can affect how quickly shelf pricing adjusts.

Do OTC store brands reduce CLARITIN faster than pharmacy generics?

Store brands often reduce faster in mass retail due to aggressive pricing, end-cap merchandising, and direct equivalence positioning, which increases consumer switching.

Does CLARITIN compete more on efficacy or on side-effect perception?

In consumer OTC decisions for antihistamines, side-effect perception (especially sleepiness) and dosing convenience often influence switching alongside price.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. Hatch-Waxman Act overview. U.S. FDA and FTC educational materials (primary statutory framework). https://www.fda.gov/

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