Last Updated: June 25, 2026

CLARITIN-D 24 HOUR Drug Patent Profile


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When do Claritin-d 24 Hour patents expire, and what generic alternatives are available?

Claritin-d 24 Hour is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in CLARITIN-D 24 HOUR 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.

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Recent Clinical Trials for CLARITIN-D 24 HOUR

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

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

See all CLARITIN-D 24 HOUR clinical trials

Pharmacology for CLARITIN-D 24 HOUR

US Patents and Regulatory Information for CLARITIN-D 24 HOUR

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-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CLARITIN-D 24 HOUR

See the table below for patents covering CLARITIN-D 24 HOUR around the world.

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

Supplementary Protection Certificates for CLARITIN-D 24 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 08C0004 France ⤷  Start Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897 C00152897/01 Switzerland ⤷  Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897 SPC/GB01/012 United Kingdom ⤷  Start Trial 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 ⤷  Start Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: June 17, 2026

CLARITIN-D 24 HOUR (loratadine + pseudoephedrine) market dynamics, pricing, and financial trajectory

Claritin-D 24 Hour (loratadine 10 mg + pseudoephedrine ER, branded “CLARITIN-D 24 HOUR”) sits in the crowded US OTC allergy and congestion market where volume and price are primarily driven by (1) seasonal demand, (2) cold-weather and allergy-year intensity, (3) retailer shelf and private-label switching, and (4) regulatory and operational constraints around pseudoephedrine distribution. Financial trajectory for the brand depends on whether it retains premium pricing versus fast-growing generic equivalents and store brands at the same strength and ER dosing, and whether it can sustain loyalty through convenience formats and controlled dispensing channels.

Bottom line: the long-run economics skew toward share erosion and margin pressure as pseudoephedrine/loratadine combinations become increasingly substitutable across branded, store-brand, and multi-source generic SKUs. Short-run swings track allergy season severity and consumer promotions, with most financial impact landing in retail pharmacy and mass channels rather than specialty care or payer reimbursement.


How does CLARITIN-D 24 HOUR make money in the US OTC market?

Revenue mechanics are retail driven, not prescription driven. CLARITIN-D 24 HOUR is an over-the-counter combination product used for allergic rhinitis plus nasal congestion. Sales flow through:

  • Retail pharmacy (chains and independents)
  • Mass retail (big-box stores)
  • Club and online retail (where allowed and where retailer assortments support it)

For OTC allergy-congestion, revenue is typically a function of:

  • Unit demand during peak allergy months
  • Promo intensity
  • Retailer margin and slotting
  • Mix shift between “single-entity” antihistamines, decongestant monotherapies, and combo products
  • Substitution by generics and store brands at equivalent strength

What are the key market dynamics for CLARITIN-D 24 HOUR versus competing allergy and congestion OTC products?

1) Demand is seasonal and sensitive to weather

Allergy OTC categories typically see:

  • Higher sales in spring and early summer in many regions
  • Variable outcomes based on regional pollen load and winter-to-spring weather patterns
  • “Second wave” spikes after cold snaps followed by warming events in some geographies

Combo products that include a nasal decongestant usually track with perceived congestion prevalence, not only allergy symptom burden.

2) Pseudoephedrine is distribution constrained and operationally complex

Even with OTC status, pseudoephedrine has:

  • Controlled-sale processes at many retail sites (ID checks, tracking, log requirements depending on retailer policy and state rules)
  • Operational friction relative to non-pseudoephedrine alternatives (e.g., antihistamines alone or phenylephrine-based OTC products)

That friction can cap growth during periods when retailers tighten compliance or reduce pseudoephedrine shelf presence.

3) Retailer assortment and private label pressure the brand

The US OTC market routinely uses:

  • Store brands at similar strength
  • Multi-source generics
  • Promo-funded share captures during seasonal peaks

As more SKUs are available at comparable price points, the brand’s growth depends more on:

  • Shelf placement and planogram strategy
  • Consumer familiarity and pack-size convenience
  • Store-specific promotion cycles

4) Channel shift can change the brand’s effective price

If consumer shopping migrates toward:

  • Mass retailers that favor lower-cost formats, or
  • Online marketplaces that enforce price transparency and frequent discounting, the brand’s realized net pricing can compress.

How does CLARITIN-D 24 HOUR pricing and promo behavior affect its financial trajectory?

Featured snippet: Main driver of financial trajectory

Realized performance is most sensitive to net pricing versus store-brand and generic equivalents during allergy season promotions.

Key pricing levers that influence financial trajectory:

  • Promotional depth: % off, buy-more-save-more, “seasonal resets” after peak months
  • Pack configuration and dosing: 24-hour ER formats reduce perceived inconvenience versus immediate-release alternatives
  • Retailer margin management: retailers may rotate slower-moving brands out of high-traffic zones in favor of better-margin store brands

Margin profile reality for OTC

OTC brands often face:

  • Higher promotional intensity than specialty
  • Higher trade spending if they must defend shelf share
  • Margin compression if retailers demand deeper co-op advertising or listing fees

What is the competitive landscape for CLARITIN-D 24 HOUR in the US?

Primary substitution set

CLARITIN-D competes with:

  • Generic loratadine + pseudoephedrine ER products (multiple manufacturers)
  • Branded combos using similar active ingredients and comparable dosing regimes where available
  • Antihistamine-alone products (people choose less congestant-focused therapy)
  • Decongestant alternatives not requiring pseudoephedrine-controlled workflows (category substitution)

Direct competitive implication

The more the market view treats CLARITIN-D as “one of many equivalent combos,” the faster:

  • Brand share erodes
  • Price competition intensifies
  • Volume growth becomes harder

In practice, the brand often remains relevant in high-loyalty segments but faces persistent substitution pressure in mass and value channels.


When does CLARITIN-D 24 HOUR lose exclusivity? How do those timelines shape revenue?

Featured snippet: Exclusivity is largely irrelevant for combination OTC performance today.
For CLARITIN-D 24 HOUR, market economics are driven less by patent term calendars and more by the practical availability of multi-source generics and store brands at comparable dosing. Combination actives (loratadine and pseudoephedrine ER) have long market histories, meaning the brand’s present revenue trajectory is shaped by:

  • Generic and store-brand penetration
  • Retailer pricing strategies
  • Consumer substitution rather than remaining regulatory exclusivities

Because OTC revenue typically reflects ongoing competitive conditions rather than “patent cliffs,” the “loss of exclusivity” concept manifests as continued share shift rather than a single step-change event.


What generic entry risks exist for CLARITIN-D 24 HOUR (combination OTC)?

Featured snippet: Main generic entry risk is ongoing multi-source competition

The generic risk is not a one-time entry. It is:

  • Continuous as manufacturers expand SKUs, pack sizes, and promotional readiness
  • Store-brand rollout that reduces the brand’s ability to command premium pricing

Operational barrier profile

Compared with prescription products, the primary barriers are:

  • Retail compliance and pseudoephedrine handling
  • Ability to win shelf space and promotions

Where these are manageable, new entrants and store brands can scale, increasing competitive pressure.


What is the FDA and regulatory status of CLARITIN-D 24 HOUR?

OTC monograph vs NDA dynamics

CLARITIN-D 24 HOUR is an OTC product. Regulatory treatment for OTC antihistamine and decongestant actives in the US has historically involved legacy frameworks and approved labeling categories for specific actives and dosing instructions, with ongoing updates driven by:

  • Safety communications
  • OTC labeling requirements
  • Adherence to marketed conditions

Practical impact on market

Regulatory status influences:

  • Label compatibility for substitutes
  • Whether retailers can carry comparable pack formats
  • Consumer confidence and switching behavior

For market dynamics, the core point is that the product competes within an established OTC framework where substitutes are broadly permissible.


What does the financial trajectory look like without payer reimbursement: retail scan patterns and seasonality?

Featured snippet: Financial trajectory follows seasonality more than life-cycle events

CLARITIN-D 24 HOUR’s annual sales pattern usually reflects:

  • Rising demand in allergy peaks
  • Retail promo cycles that pull forward purchases
  • Post-peak discounting to clear inventory

In years with heavy pollen seasons, combo decongestant products can see:

  • Higher unit sales during peak weeks
  • Better absorption of fixed retail trade spends

In mild seasons, the brand often relies more on:

  • Promo effectiveness
  • Mix in channels less exposed to store-brand switching

How does CLARITIN-D 24 HOUR compare with loratadine + pseudoephedrine generics on market impact?

Comparison lens that matters commercially

For OTC combination products, generics compete on:

  • Net price after promos
  • Pack count and convenience
  • Retail availability and shelf continuity

Branded products compete on:

  • Brand trust and label familiarity
  • Consumer perception of consistent symptom control
  • Habit purchasing

Implication for financial trajectory: branded growth is most feasible when:

  • The brand maintains premium net pricing without losing large volumes to store brands
  • Retailers keep it in top shelf positions during peak season
  • Consumer demand remains “combo-specific,” not simply “antihistamine with any congestion aid”

What could drive upside for CLARITIN-D 24 HOUR financially?

Upside typically comes from:

  • Stronger-than-average allergy seasons in key regions
  • Retailers scaling shelf placement and promo support
  • Consumer preference for 24-hour ER convenience and combo efficacy
  • Pack-size optimization that reduces price-per-dose disadvantage versus store brands

In market terms, upside is usually a mix of seasonality tailwinds plus defensive execution in retail.


What could drive downside for CLARITIN-D 24 HOUR financially?

Downside typically comes from:

  • Mild allergy seasons reducing category unit demand
  • Higher promo intensity from competitors and private label
  • Retailer planogram changes favoring value SKUs
  • Operational friction around pseudoephedrine handling that reduces availability
  • Faster consumer switching to antihistamine-alone products if congestion severity perception drops

Downside is usually a combination of volume softness and net price compression.


Key metrics to track for CLARITIN-D 24 HOUR’s financial trajectory

Even without prescription-level data, the brand’s trajectory is measurable via retail and commercial proxies:

  • Weekly retail unit sales by channel (pharmacy vs mass)
  • Net pricing and promo depth versus generic and store brands
  • Share of shelf and distribution points during peak months
  • Price-per-dose comparison by pack configuration
  • Sell-through and inventory aging post-season

These indicators usually predict annual outcomes better than long-horizon patent or regulatory events for OTC.


Key Takeaways

  • CLARITIN-D 24 HOUR’s financial trajectory is driven primarily by seasonal demand and retail competitive pricing rather than patent “exclusivity” timing.
  • Market dynamics are shaped by pseudoephedrine distribution constraints, retailer compliance operations, and store-brand substitution.
  • The brand’s long-run economics trend toward share erosion and margin pressure unless it maintains premium net pricing through shelf execution and consumer habit.
  • Upside is most likely in high pollen seasons and when retailer promo support sustains net price.
  • Downside comes from milder seasons, deeper promotions by competitors, and planogram shifts to lower-cost equivalents.

FAQs

  1. What OTC competitors most directly cannibalize CLARITIN-D 24 HOUR volume during allergy season?
    Combo loratadine + pseudoephedrine generics and store brands at equivalent dosing are the closest substitutes, followed by antihistamine-alone options that reduce pseudoephedrine purchasing friction.

  2. Does CLARITIN-D 24 HOUR performance depend more on units or on net price?
    Both matter, but trajectory often turns on net price compression vs promo intensity because unit demand is heavily seasonal while retailer pricing can shift quickly.

  3. How do pseudoephedrine regulations influence retailer participation and shelf availability?
    Retailer compliance workflows can reduce stocking intensity or limit prominence, especially when store policies become stricter, impacting brand availability during peak demand windows.

  4. What channel mix typically improves or worsens CLARITIN-D 24 HOUR economics?
    Mass and discount-oriented channels tend to accelerate value substitution and can compress net pricing, while pharmacy-focused assortments may better support premium positioning.

  5. What commercial levers are most effective to defend brand share versus generics in OTC combo categories?
    Shelf placement during peak months, pack-size and price-per-dose competitiveness, and promotion strategy that limits net price drawdowns while sustaining category relevance.


References (APA)

  1. FDA. (n.d.). OTC drug labeling and regulatory frameworks for over-the-counter products. US Food and Drug Administration.
  2. National Association of Boards of Pharmacy (NABP). (n.d.). Prescription monitoring and OTC pseudoephedrine compliance resources. National Association of Boards of Pharmacy.

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