CLARINEX Drug Patent Profile

When do Clarinex patents expire, and when can generic versions of Clarinex launch?

Clarinex is a drug marketed by Organon Llc and Organon and is included in five NDAs.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for CLARINEX

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	6,845
Drug Prices:	Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?	CLARINEX excipients list
DailyMed Link:	CLARINEX at DailyMed

See drug prices for CLARINEX

See drug sales revenues for CLARINEX

Recent Clinical Trials for CLARINEX

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

Sponsor	Phase
J. Uriach and Company	Phase 1
Derm Research, PLLC	Phase 4
UCB Pharma	Phase 4

See all CLARINEX clinical trials

Pharmacology for CLARINEX

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for CLARINEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLARINEX	Oral Solution	desloratadine	0.5 mg/mL	021300	1	2008-05-08
CLARINEX	Orally Disintegrating Tablets	desloratadine	2.5 mg and 5 mg	021165	3	2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes

EU/EMA Drug Approvals for CLARINEX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Actavis Group PTC ehf	Desloratadine Actavis	desloratadine	EMEA/H/C/002435Treatment of allergic rhinitis and urticaria.	Authorised	yes	no	no	2012-01-13
N.V. Organon	Azomyr	desloratadine	EMEA/H/C/000310Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1)	Authorised	no	no	no	2001-01-15
Ratiopharm GmbH	Desloratadine ratiopharm	desloratadine	EMEA/H/C/002404Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician	Authorised	yes	no	no	2012-01-13
N.V. Organon	Aerius	desloratadine	EMEA/H/C/000313Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	no	no	no	2001-01-15
N.V. Organon	Neoclarityn	desloratadine	EMEA/H/C/000314Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria	Authorised	no	no	no	2001-01-15

International Patents for CLARINEX

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

Country	Patent Number	Title	Estimated Expiration
Argentina	241463	PROCEDIMIENTO PARA PREPARAR AZA DERIVADOS DE PIPERILIDEN CICLOHEPTENOS, Y PROCEDIMIENTO PARA PREPARAR COMPOSICIONES FARMACEUTICAS UTILES. (PROCESS FOR PREPARING PIPERIDYLIDENE DIHYDRODIBENZO(A,D)CYCLOHEPTENES AND AZA DERIVATIVES THEREOF, COMPOUNDS OBTAINED BY SUCH PROCESS AND THE USE OF SUCH COMPOUNDS FOR PREPARING USEFUL PHARMACEUTICAL COMPOSITIONS)
Austria	47140
Austria	61364
Australia	3993885
Australia	5702690

Supplementary Protection Certificates for CLARINEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	91403	Luxembourg		91403, EXPIRES: 20220730
1110543	CA 2008 00010	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
1110543	300328	Netherlands
1110543	SPC063/2007	Ireland		SPC063/2007: 20081105, EXPIRES: 20220729
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730

Last updated: July 21, 2026

CLARINEX (desloratadine) market dynamics and financial trajectory: revenue drivers, generic pressure, and major IP/regulatory milestones

CLARINEX (desloratadine) is a late-cycle branded antihistamine with declining US brand leverage as generics displaced prescription demand and retail OTC usage consolidated under multiple manufacturers. The long-run market is driven more by OTC category behavior (seasonality, switching, formulary inertia at managed-care levels historically) than by rapid incremental innovation. In the US, the competitive shift is dominated by generic desloratadine entry and the absence of credible “stay-branded” protections in the commercial timeline.

What drives CLARINEX (desloratadine) market demand across allergy seasons?

CLARINEX participates in the second-generation H1-antihistamine class, where market share is shaped by:

• Seasonal pharmacy and retail sell-through tied to spring and fall allergy spikes.
• OTC/behind-the-counter channel mix: desloratadine is widely sold via retail drugstores after genericization; brand premium erodes as equivalent generics gain price advantage.
• Patient switching behavior: second-generation non-sedating profiles reduce perceived differentiation. Loyalty shifts toward habit and price at the point of sale.
• Formulation availability and pack sizes: tablet strength and liquid pediatric options determine shelf placement and pediatric recommender patterns.

Featured snippet answer: CLARINEX demand is primarily seasonal and price-sensitive after generic entry, with differentiation limited to brand familiarity and packaging rather than clinical superiority.

How does channel mix (Rx vs OTC) affect CLARINEX unit economics?

• Pre-generic prescription era: brand pricing supported higher net revenue per prescription, with rebates and formulary positioning.
• Post-generic era: retail competition compresses margin; manufacturer focus shifts to promotional intensity, pack-size optimization, and trade terms to secure shelf velocity.
• Payer dynamics: once generics are established, preferred status moves rapidly toward the lowest net-cost products.

What are the typical seasonal and geographic demand patterns for desloratadine?

• Geography: US dominates commercial relevance for branded legacy analysis, with EU/Canada following similar allergy seasonality.
• Seasonality: spring peaks in temperate regions; fall peaks where ragweed and indoor/outdoor triggers persist.
• Competition: adjacent antihistamines (cetirizine, loratadine, levocetirizine) compete on side-effect profile and dosing frequency rather than on drug class novelty.

---

When did CLARINEX lose exclusivity in the US and what replaced it commercially?

Featured snippet answer: US brand exclusivity for CLARINEX ended as generic desloratadine launched, shifting the market from branded prescriptions toward generic tablets and liquids sold through retail channels.

What generic entry risks matter for CLARINEX long-term share?

• Paragraph IV and ANDA timing historically matter most when patents and exclusivity are active. After successful generic launches, market structure becomes stable: low-cost generics compete on price and distribution rather than on new-to-market disruption.
• Ongoing “design-around” is not typically required for small molecules like desloratadine once core composition and method patents expire. The economic threat is sustained price undercutting.

Generic substitution dynamics after launch

• Formulary migration: once generic desloratadine became preferred or default, managed care formularies reduced brand utilization.
• Retail substitution: pharmacists substitute automatically if the brand is not required by prescription restrictions.
• Brand retention strategy: brands often exit or downshift marketing spend post-generic to preserve cash margins, which accelerates share decline.

---

What does the CLARINEX patent and regulatory landscape imply for financial trajectory?

Featured snippet answer: CLARINEX’s financial trajectory is consistent with a legacy small-molecule antihistamine model: peak branded revenue during market formation, then sustained decline as generics take share, leaving only residual premium where contractual or patient-specific factors keep brand usage.

How do patent estate characteristics shape revenue survivability for desloratadine?

• Core composition and key formulation patents typically expire on a predictable schedule for older small molecules.
• Lifecycle management (new formulations, pediatric indications, extended-release, dosing convenience) can delay generic entry when new patentable matter supports an updated regulatory label.
• For CLARINEX specifically, the market behavior indicates that remaining IP did not preserve durable brand economics after genericization.

Orange Book dynamics and exclusivity

For legacy branded antihistamines, the Orange Book usually moves from:

1. Brand-listed patents and possible exclusivity,
2. Followed by ANDA certifications and generic approvals,
3. Ending with only residual listings or litigation outcomes that do not materially re-create exclusivity.

(Commercial inference aligns with the observed shift to widely available generics and OTC availability.)

---

What is the financial trajectory pattern for branded desloratadine historically?

A typical trajectory for CLARINEX-type legacy branded small molecules looks like:

• Early ramp: product adoption and physician familiarity build prescription base.
• Peak period: strong branded pricing and formulary wins.
• Inflection: generic entry triggers discontinuation of brand promotion intensity and a rapid shift to lower-priced alternatives.
• Late-cycle: brand revenue becomes nominal relative to total category volume; manufacturers focus on remaining high-retention channels, if any.

Featured snippet answer: The post-generic phase converts branded market behavior into a low-margin, price-competitive commodity where brand revenues track with minor premium retention rather than category growth.

What category-level drivers keep the market from collapsing?

• Allergy prevalence growth in absolute terms supports steady category volume.
• Seasonal demand refresh: even if market share shifts, total purchases rise during allergy spikes.
• Pediatric dosing and liquid formats sustain demand, but generics match those formats quickly.

How do marketing and supply chain economics change post-generic?

• Brand manufacturer marketing declines or reallocates to newer assets.
• Working capital and supply become optimized for stable, small price differentials rather than premium branding.

---

Which companies dominate the CLARINEX (desloratadine) competitive landscape after genericization?

Featured snippet answer: The desloratadine market becomes a multi-manufacturer generic ecosystem, typically led by companies with scale advantages in manufacturing and distribution and strong retail trade relationships.

Because the question targets “market dynamics and financial trajectory,” the decisive factor is not one competitor but the structural outcome:

• Generic substitution eliminates branded pricing power.
• Retail and PBM formularies reward net-cost competitiveness.
• Shelf space and pack-size availability determine share of stomach for OTC purchases.

What competitive vectors matter most for desloratadine generics?

• Unit cost and manufacturing yield.
• Trade spend and retail placement.
• Stability and compliance for liquid formulations.
• Launch timing coordination to minimize price dips and capture seasonal demand.

---

How does CLARINEX compare with competing second-generation antihistamines in market resilience?

Featured snippet answer: Desloratadine competes directly with cetirizine, levocetirizine, loratadine, and (in some contexts) other allergy agents. Market resilience after genericization depends on dosing convenience, taste/administration for liquids, and historical familiarity, not on patent-protected clinical differentiation.

Key comparison points that affect share

• Onset and perceived efficacy: many second-generation antihistamines are clinically similar, driving adoption by patient preference and tolerability.
• Sedation perception: slight differences in patient-reported somnolence affect repeat use.
• Dosing frequency: once-daily regimens are standard; small differences matter less once generics are available.

Why do some antihistamines maintain stronger category positions?

• Brand legacy in patient minds may retain small share even after generic launch.
• Formulation execution (especially pediatric liquids) can sustain doctor and parent trust.
• Distribution strength: products that secure prime planograms and rebate structures hold share.

---

What generic launch scenarios exist for CLARINEX and what are the likely financial impacts?

Featured snippet answer: After first generic entry, the incremental financial impact shifts from “existential” to “margin compression,” driven by multiple abbreviated launches and price convergence.

Scenario 1: Single first generic captures most Rx share

• Brand revenue falls quickly, then stabilizes at low levels as remaining brand users convert to generics.

Scenario 2: Multiple ANDA launches accelerate price convergence

• Faster margin erosion.
• Greater promotional pressure across retailers and mail order pharmacies.

Scenario 3: Formulation-specific competition (liquid vs tablet)

• Pediatric and liquid formulations can remain comparatively more resilient until competitive products match taste and stability benchmarks.
• Over time, liquids also commoditize.

Scenario 4: Margin recovery through pharmacy network contracting

• Manufacturers can regain some margin via rebates or contract access.
• This does not reverse brand decline unless the brand repositions as a differentiated product, which typically requires new IP.

---

What FDA status and labeling scope shape CLARINEX category participation?

Featured snippet answer: CLARINEX is positioned within allergy indications for which broad OTC and retail penetration occurs once generics exist, enabling sustained category volume irrespective of brand economics.

Key regulatory implications:

• Indication breadth supports persistent demand.
• Switching to generics does not remove patient need, so the “market” stays but the “brand” value drops.
• Pediatric acceptability for liquid dosing supports continuing demand even when Rx use diminishes.

---

How strong is the patent estate for CLARINEX today and what does it mean for investors?

Featured snippet answer: The observable commercial structure indicates that CLARINEX’s enforceable exclusivity is largely exhausted, leaving investors focused on category-level growth rather than brand protection.

For legacy small-molecule antihistamines:

• IP strength at this stage rarely creates a durable moat against multiple generic suppliers.
• Financial upside is generally limited to manufacturing scale, distribution leverage, and cost efficiency, not to patent-driven pricing.

---

Key Takeaways

• CLARINEX market dynamics are dominated by seasonality and price competition after generic substitution.
• The financial trajectory follows a legacy branded small-molecule pattern: peak branded usage, then rapid brand erosion and prolonged commodity economics.
• Competitive advantage shifts away from IP differentiation toward manufacturing scale, retail shelf placement, and rebate/contract execution.
• For financial modeling, the key lever is category volume resilience (allergy season demand) rather than brand exclusivity.

---

FAQs

How quickly do brands like CLARINEX lose share after generic desloratadine approval?

Generic substitution typically compresses brand share rapidly after launch, with residual retention limited to prescription-specific and patient-convenience factors.

Does the liquid pediatric formulation protect CLARINEX brand revenue longer than tablets?

Liquids can show slower commoditization in practice due to formulation execution and patient preference, but they generally converge to generic price competition once equivalent products scale.

What seasonal forecasting inputs best predict desloratadine demand?

Historical allergy season pharmacy sell-through, regional pollen calendars, and retail promotion calendars are the most actionable inputs.

Can method-of-use or formulation patents materially extend CLARINEX brand exclusivity?

For established legacy antihistamines, the commercial evidence typically indicates remaining patent matter does not restore durable brand economics against multiple generic entrants.

Is the desloratadine market more sensitive to retail pricing or pharmacy contract rebates?

It is generally sensitive to both, with retail shelf pricing and trade conditions shaping OTC dynamics and PBM contracting shaping Rx channel outcomes.

---

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.