acrivastine; pseudoephedrine hydrochloride - Profile

What are the generic sources for acrivastine; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Acrivastine; pseudoephedrine hydrochloride is the generic ingredient in one branded drug marketed by Endo Operations and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for acrivastine; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for acrivastine; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994		DISCN	Yes	No

Expired US Patents for acrivastine; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	4,501,893
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	4,650,807

Acrivastine + Pseudoephedrine Hydrochloride (H1 Antihistamine + Decongestant): Investment Scenario, Patent/Exclusivity Fundamentals, and Commercial Outlook

Last updated: May 31, 2026

What are the key investment fundamentals for acrivastine + pseudoephedrine hydrochloride?

Acrivastine plus pseudoephedrine hydrochloride is a fixed-dose, over-the-counter (OTC) combination used for nasal and upper respiratory symptom relief (typically allergic rhinitis and related congestion). The investment thesis is driven by: (1) low unit economics historically typical of OTC combo products, (2) the extent of remaining brand and formulation differentiation, (3) regulatory and manufacturing compliance for combination products, and (4) pricing pressure from generics in most markets.

Core fundamentals to underwrite

• Category structure: Short-duration, episodic use; demand is seasonal and sensitive to retail promotions and pharmacy channel stocking cycles.
• Competitive intensity: High probability of multiple authorized generic and OTC equivalents across jurisdictions.
• Regulatory status (typical): OTC monographs/approved-label combinations vary by country; combination approval and labeling constraints shape market access.
• Patent shelf: For most markets, key “platform” molecules are long out of patent, leaving investment value primarily in secondary patents (formulations, processes, polymorphs, particle engineering, controlled-release variants, and line extensions).

Investment scenarios (framework)

• Bear case: Rapid price erosion from multi-source generics; brand loses share as retail substitutes expand; enforcement cost for any remaining exclusivity is not justified.
• Base case: Sustained premium in select geographies via entrenched brand or retailer exclusivity; modest share gains from packaging differentiation and channel execution.
• Bull case: Re-launch with differentiated delivery or improved tolerability claims using remaining IP around formulation/process, creating a defensible “life-cycle” moat in specific markets.

What patents protect acrivastine + pseudoephedrine hydrochloride, and how many are likely active?

Acrivastine and pseudoephedrine hydrochloride are well-established actives. In most major jurisdictions, primary composition and early method-of-use IP has largely expired. For a current investment-grade view, value typically sits in secondary patent layers:

• Solid-state forms (polymorphs, hydrates/solvates)
• Particle size / crystallinity or engineered powders for dissolution and bioavailability
• Controlled release or extended release dosage forms
• Manufacturing process improvements
• Specific combination ratios and stabilized formulations
• Optional “use” claims tied to symptom domains (e.g., allergic rhinitis with congestion)

High-confidence practical takeaway for investors

• Most markets: Treat the core actives as effectively off-patent for composition and basic combination use.
• Defensible pockets: Only worth modeling when there is evidence of active, enforceable patents in the target geography and dosage form.

When does acrivastine + pseudoephedrine hydrochloride lose exclusivity in major markets?

For many OTC combination products built from mature actives, “loss of exclusivity” is not one date. It is the combined effect of:

1. expiry of composition patents for the actives and their early combination,
2. expiry of formulation and process patents (if any remain),
3. expiry of data exclusivity periods (where applicable), and
4. expiration of any SPC (Supplementary Protection Certificate) where granted.

Investment-grade modeling approach

• Build exclusivity timelines by jurisdiction and dosage form, not by drug substance alone.
• If a company’s investment hinges on price protection, validate whether any listed exclusivity remains for the exact formulation in each target market. If not, valuation should reflect competitive OTC multi-source dynamics.

What is the Orange Book status of acrivastine + pseudoephedrine hydrochloride (US)?

The US exclusivity landscape for OTC fixed-dose combinations is typically dominated by:

• NDA/ANDA history for the exact product,
• Orange Book listings (if any) tied to approved formulations,
• expiration of any listed patents or exclusivity.

Investment implication

• US exposure is usually less about brand exclusivity and more about brand equity, distribution, and retailer procurement economics once generics are widely available.

How strong is the patent estate for acrivastine + pseudoephedrine hydrochloride?

Expected strength profile (typical OTC reality)

• Weak on composition: likely extensive generic freedom due to early expiry of fundamental claims.
• Moderate only if secondary IP exists: formulation/process/control-release or specialized particle engineering can remain enforceable for a period.
• Low leverage: even if some patents remain, OTC products face intense practical switching by pharmacists and consumers, reducing the ability to sustain pricing above competitive equilibrium.

Commercial underwriting consequence

• If investing in a branded OTC unit, discount the probability that remaining patents create true pricing power unless the IP maps precisely to the marketed product and is enforceable against labeled generics.

What formulations are protected (immediate-release vs controlled-release) for acrivastine + pseudoephedrine hydrochloride?

OTC combos commonly ship as immediate-release oral tablets/capsules. Investment relevance concentrates on whether any competitor differentiation relies on:

• Modified-release systems (if present in the market)
• High stability and moisture protection technologies for fixed-dose blends
• Enhanced dissolution or faster onset formulations
• Packaging and dose regimen that enable labeling differentiation

Decision point for investors

• If the marketed product is immediate-release and the same strength can be manufactured under generic-friendly specs, formulation IP value is limited.

What generic entry risks exist for acrivastine + pseudoephedrine hydrochloride?

Generic entry risk is driven by:

• Regulatory substitutability: ability to replicate the same dosage form, strength, and labeling.
• Manufacturing feasibility: blending stability, excipient compatibility, and content uniformity for fixed-dose combos.
• Retail channel behavior: OTC products often show rapid substitution once multiple suppliers are available.

Risk conclusion

• For most territories, the principal risk is not “whether” generics can enter, but how quickly shelf pricing collapses after procurement cycles switch to lower-cost suppliers.

How does acrivastine + pseudoephedrine hydrochloride compare with competing OTC antihistamine/decongestant combinations?

Competitive set usually includes other first-generation or second-generation antihistamine plus decongestant combinations (depending on country labeling and OTC classification). Investors should model share and price elasticity by comparing:

• onset claims and symptom coverage,
• side-effect profile and contraindication language,
• dosing frequency and tablet size,
• brand heritage and pharmacy shelf position.

Strategic implication

• Without strong residual IP, brand and channel execution dominate. Generic substitution threatens any product whose consumers view it as interchangeable.

What patent litigation affects acrivastine + pseudoephedrine hydrochloride?

For mature OTC fixed-dose combinations, patent litigation is typically sporadic and narrow, often centered on:

• secondary formulation/process patents,
• patent listings specific to a particular manufacturer’s approved product,
• or settlement dynamics around ANDA/generic launches.

Investment takeaway

• Absent known, active litigation tied to a target brand’s specific formulation, litigation risk should not be treated as a primary driver of valuation. OTC pricing is usually a procurement and competitive intensity function.

What settlement agreements or Paragraph IV challenges exist for acrivastine + pseudoephedrine hydrochloride?

Paragraph IV challenges require an ANDA and a listed patent in the Orange Book for the reference listed drug (RLD). For many OTC combinations of older actives, either:

• there are no meaningful remaining listed patents, or
• the listed patents do not cover the commercially relevant formulation, limiting litigation utility.

Investment use

• Treat Paragraph IV as a low-probability value catalyst unless the target product has active Orange Book listings that create a time-bound exclusivity and are plausibly challenged.

What is the FDA regulatory status of acrivastine + pseudoephedrine hydrochloride?

In the US, OTC products are regulated through NDA/ANDA pathways and must follow current good manufacturing practice (cGMP) and labeling requirements. For investors, the key regulatory considerations are:

• whether the exact combination/strength is marketed under an approved application,
• quality system compliance for scale-up and lifecycle changes,
• risk of labeling changes tied to safety updates for decongestants and antihistamines.

Investment relevance

• Regulatory risk is less about approval timelines and more about compliance stability and potential label or formulation updates affecting supply continuity.

How does biosimilar risk apply to acrivastine + pseudoephedrine hydrochloride?

Biosimilar risk does not apply. This is a small-molecule OTC combination, not a biologic.

What are the commercial drivers and revenue exposure mechanics for this OTC combo?

Revenue is driven by

• seasonal peaks in allergic rhinitis and cold-season congestion,
• retail and pharmacy distribution reach,
• promotional intensity and pricing corridors,
• substitutability among multiple generics and branded equivalents,
• regulatory and scheduling restrictions impacting pseudoephedrine availability in certain jurisdictions.

Key exposure mechanics for investors

• Inventory cycle risk: OTC retailers reorder ahead of peak seasons; demand shortfalls can create markdown pressure.
• Pricing compression: generic entry tends to compress gross margin quickly.
• Channel concentration: performance can be materially affected by a small number of large retail contracts.

Geographic investment scenario: where is margin protection most plausible?

Margin protection is most plausible where:

• brand penetration is high and generics are fewer,
• OTC switching barriers exist due to formulation uniqueness or pharmacy channel incentives,
• regulatory constraints on decongestant availability limit parallel supply.

Margin compression is most likely where:

• multiple authorized generics and parallel imports are widespread,
• procurement centralizes around lowest-cost suppliers,
• labeling and strength equivalence make switching frictionless.

What manufacturing and IP barriers exist for acrivastine + pseudoephedrine hydrochloride?

IP barriers likely to matter

• solid-state stability technologies,
• specific manufacturing process claims (if any remain),
• controlled-release or engineered particle approaches (if present).

Manufacturing barriers likely to matter

• moisture and stability control in fixed-dose blends,
• content uniformity for low-dose actives,
• batch reproducibility and dissolution specifications aligned to approved reference products.

Investment relevance

• Even with weak composition IP, high-quality manufacturing and supply reliability are a competitive advantage because OTC buyers demand continuity.

How does the competitive landscape change after generic availability ramps up?

Typical post-generic pattern for OTC combinations:

• branded share shrinks to “loyal customer” segments and premium shelf placements,
• pricing falls toward generic parity,
• promotional spend increases as brands defend shelf presence,
• companies with manufacturing cost advantages gain volume.

Investment consequence

• In base-case valuation, assume margin stabilization only if the investor controls supply costs or retains branded differentiation that prevents full price convergence.

Key Takeaways

• Acrivastine + pseudoephedrine hydrochloride is an OTC fixed-dose combination where the investment thesis is usually driven by distribution and competitive intensity rather than long-lived composition IP.
• Patent-driven exclusivity is typically limited for mature actives; remaining value, if any, is most often in narrow secondary formulation or process IP tied to specific marketed dosage forms.
• Generic entry risk is structurally high in most markets because the actives are mature and labeling/strength equivalence supports fast substitution.
• The highest-margin opportunities tend to be geography- and channel-specific, where brand penetration or supply constraints slow price convergence.

FAQs

1. Which secondary patents (formulations or manufacturing processes) are most likely to remain relevant for OTC antihistamine–decongestant combinations like acrivastine + pseudoephedrine?
2. How should investors model seasonal demand and inventory cycles for OTC allergic rhinitis symptom relief products?
3. What regulatory labeling changes for pseudoephedrine-containing OTC products could impact market access or prescription-to-OTC switching?
4. How do procurement contracts and pharmacy channel incentives influence price erosion after generic launches for fixed-dose combination OTC drugs?
5. What due diligence steps most directly test whether any remaining IP can block generic substitution for a specific acrivastine + pseudoephedrine formulation?

References

No sources were provided in the prompt, and no citations can be generated without verifiable inputs.