ATARAX Drug Patent Profile

Which patents cover Atarax, and what generic alternatives are available?

Atarax is a drug marketed by Roerig and Pfizer and is included in two NDAs.

The generic ingredient in ATARAX is hydroxyzine hydrochloride. There is one drug master file entry for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atarax

A generic version of ATARAX was approved as hydroxyzine hydrochloride by CHARTWELL RX on April 12^th, 1982.

Summary for ATARAX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	5
Patent Applications:	5,035
DailyMed Link:	ATARAX at DailyMed

See drug sales revenues for ATARAX

Recent Clinical Trials for ATARAX

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

Sponsor	Phase
Sultan Qaboos University	Phase 4
Bnai Zion Medical Center	N/A
ARAMU Association	Phase 4

See all ATARAX clinical trials

US Patents and Regulatory Information for ATARAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roerig	ATARAX	hydroxyzine hydrochloride	SYRUP;ORAL	010485-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	ATARAX	hydroxyzine hydrochloride	TABLET;ORAL	010392-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	ATARAX	hydroxyzine hydrochloride	TABLET;ORAL	010392-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Pfizer	ATARAX	hydroxyzine hydrochloride	TABLET;ORAL	010392-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Atarax Market Dynamics, Patent Status, Generic Competition, and Financial Trajectory

Last updated: August 14, 2026

Atarax is the former brand name for hydroxyzine hydrochloride, an antihistamine used for anxiety, pruritus, and preoperative sedation. Its commercial profile is now dominated by low-priced generic hydroxyzine products rather than branded Atarax sales. The product has no meaningful remaining innovator exclusivity, no active biosimilar issue, and limited patent-based barriers to entry. Financial value sits primarily in generic manufacturing, distribution, and institutional supply rather than in the Atarax brand.

What is Atarax and how is it used?

Atarax contains hydroxyzine hydrochloride. Hydroxyzine is a first-generation antihistamine with sedative and anticholinergic effects. FDA labeling identifies use for anxiety, symptomatic relief of pruritus, and preoperative sedation.[1]

Hydroxyzine is marketed in two principal salt forms:

Product	Active ingredient	Common dosage forms	Primary commercial status
Atarax	Hydroxyzine hydrochloride	Tablets, oral solution, historically injection	Legacy brand
Vistaril	Hydroxyzine pamoate	Capsules, oral suspension	Legacy brand
Generic hydroxyzine HCl	Hydroxyzine hydrochloride	Tablets, syrup, oral solution	Main U.S. supply
Generic hydroxyzine pamoate	Hydroxyzine pamoate	Capsules, oral suspension	Main U.S. supply

The hydrochloride and pamoate products are related but are not identical dosage forms. Prescribing, reimbursement, and substitution depend on the specific product and formulation.

Hydroxyzine is also used off-label for insomnia, acute anxiety, nausea, and short-term sedation. Its sedative effects and anticholinergic burden limit use in some older patients and in combination with alcohol, opioids, benzodiazepines, or other central nervous system depressants. FDA labeling warns about drowsiness and advises caution with activities requiring mental alertness.[1]

What is the FDA regulatory status of Atarax?

Atarax is a legacy small-molecule prescription product. FDA records identify hydroxyzine hydrochloride products under older New Drug Application pathways, while current U.S. supply is largely provided through abbreviated new drug applications, or ANDAs.

The FDA’s discontinued-drug framework distinguishes between products discontinued for commercial reasons and products withdrawn for safety or effectiveness concerns. A product’s appearance on a discontinued list does not by itself mean that FDA determined the product was unsafe or ineffective.[2]

The practical regulatory position is:

• Historical Atarax branding has little current commercial relevance in the United States.
• Generic hydroxyzine hydrochloride products remain available.
• Hydroxyzine is not a biologic and does not require biosimilar competition analysis.
• The principal regulatory pathway for current competitors is ANDA approval.
• Product-specific availability varies by manufacturer, dosage form, and wholesaler inventory.

What patents protect Atarax and hydroxyzine?

No commercially significant active patent estate protects the original Atarax molecule in the United States. Hydroxyzine was introduced decades ago, and any composition-of-matter or original product patents would have expired long before the current generic market developed.

The relevant intellectual-property categories are limited to:

1. Historical compound and composition patents.
2. Legacy formulation patents, if any were filed for specific dosage forms.
3. Manufacturing-process patents for particular intermediates or production routes.
4. Packaging, labeling, or device rights associated with a specific supplier.

These categories do not create a meaningful barrier around standard hydroxyzine tablets, capsules, or oral solutions.

Does Atarax have Orange Book patent protection?

Atarax does not have a commercially relevant Orange Book patent barrier comparable to recently approved branded drugs. The original product is a legacy medicine, and generic hydroxyzine products have competed for many years.

An Orange Book listing does not itself establish market exclusivity. Patent status must be evaluated against the specific NDA, dosage form, current listing status, and any listed patents or exclusivity codes.[3] For hydroxyzine, the market conclusion is straightforward: generic entry is established, and patent-based blocking rights are not a material commercial constraint.

When did Atarax lose exclusivity?

Atarax lost practical exclusivity decades ago. The drug predates the modern Hatch-Waxman market structure, and hydroxyzine products have long been available from multiple generic suppliers.

The current market has none of the standard launch protections associated with a recently approved product:

Exclusivity category	Atarax position
New chemical entity exclusivity	Expired or historically unavailable under current standards
Five-year Hatch-Waxman exclusivity	Not commercially relevant
Three-year new clinical investigation exclusivity	None of current commercial significance
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	Not commercially relevant
Qualified infectious-disease exclusivity	Not applicable
Patent term extension	Not commercially relevant
Regulatory exclusivity remaining	None of practical significance

Generic applicants therefore do not need to wait for a current Atarax exclusivity period to end.

How many patents cover hydroxyzine?

The original hydroxyzine molecule is not protected by a meaningful active U.S. patent estate. Any surviving rights would more likely relate to a narrow manufacturing process, a specific formulation, or a jurisdiction outside the United States.

A patent count based only on historical documents can overstate commercial protection. Older patent families may remain visible in databases even though their enforceable terms expired decades ago. For business analysis, the relevant measure is not the number of historical documents but whether an unexpired patent can block an ANDA or generic launch. For standard hydroxyzine products, that blocking risk is minimal.

Are there Paragraph IV challenges involving Atarax?

Paragraph IV litigation is not a central issue for Atarax. Paragraph IV certifications typically arise when an ANDA applicant challenges unexpired patents listed for a branded reference product. Hydroxyzine’s generic market matured long ago, and no active, commercially meaningful Atarax patent challenge is known to define the current market.

The competitive process is therefore based on:

• ANDA approval;
• manufacturing economics;
• product availability;
• wholesaler contracting;
• pharmacy substitution;
• reimbursement;
• shortage management; and
• regulatory compliance.

The absence of meaningful Paragraph IV activity reduces litigation risk but also eliminates the value of patent-based launch exclusivity.

What formulations are protected by Atarax?

No current Atarax formulation appears to carry a material market-blocking position. Hydroxyzine products are available in several dosage forms:

Formulation	Commercial considerations
Hydroxyzine HCl tablets	Low-cost, mature generic category
Hydroxyzine HCl oral solution or syrup	Fewer suppliers than tablets; manufacturing and supply continuity matter more
Hydroxyzine pamoate capsules	Established generic competition
Hydroxyzine pamoate suspension	More limited product availability and greater formulation complexity
Injectable hydroxyzine	Historical or limited-use product; sterile manufacturing creates higher barriers

Oral liquid products can have higher operational barriers than tablets because manufacturers must control concentration, preservative systems, taste, container closure, microbial quality, and dose-measurement accuracy. Those barriers are manufacturing and regulatory barriers, not Atarax patent barriers.

Which companies are challenging Atarax?

No prominent company is challenging Atarax through an active patent-centered litigation campaign. The relevant competitors are generic manufacturers and contract suppliers.

The U.S. hydroxyzine market may include products from manufacturers such as:

• Amneal Pharmaceuticals;
• Hikma Pharmaceuticals;
• Lannett or successor operations;
• Major Pharmaceuticals and other private-label suppliers;
• Teva Pharmaceuticals;
• Rising Pharmaceuticals;
• AvKARE and institutional distributors; and
• regional or contract-manufacturing suppliers.

Supplier participation changes over time. A company may hold an approved product but have limited commercial distribution, or may suspend production because of economics, manufacturing remediation, or supply-chain constraints.

How strong is the Atarax patent estate?

The Atarax patent estate is commercially weak because the product is old, genericized, and not protected by a current composition-of-matter monopoly.

Patent-estate factor	Assessment
Core molecule protection	Expired
Brand-specific formulation protection	No material current barrier identified
Orange Book blocking position	Not commercially significant
Generic substitution resistance	Low
Manufacturing know-how	Moderate for liquids and sterile products
Litigation leverage	Low
Geographic differentiation	Possible outside the U.S., but not a global exclusivity thesis
Life-cycle management value	Limited

Hydroxyzine’s residual defensibility comes from operational execution. A reliable manufacturer with approved liquid, capsule, or sterile products may retain share even in a commoditized market. That advantage is vulnerable to price competition and supply disruptions.

What is the generic entry risk for Atarax?

Generic entry risk is effectively realized rather than prospective. Hydroxyzine has been generic for many years.

The market risks are different from those for a newly launched branded drug:

• Price erosion from multiple ANDA holders.
• Loss of pharmacy shelf preference.
• Tender-driven volume shifts.
• Product discontinuation by low-margin suppliers.
• Short-term shortages if too few manufacturers remain.
• Increased scrutiny of oral-liquid quality and labeling.
• Substitution between hydroxyzine hydrochloride and hydroxyzine pamoate where clinically and legally appropriate.

Generic pricing is usually constrained by the low clinical differentiation of standard hydroxyzine products. A supplier can still improve margins through lower-cost manufacturing, dependable fill rates, efficient packaging, and institutional contracts.

What is the competitive landscape for hydroxyzine?

Hydroxyzine competes in several overlapping markets.

Anxiety and sedation

Hydroxyzine competes with benzodiazepines, buspirone, sedating antidepressants, and nonprescription sleep products. Its advantages include a long history of use, low acquisition cost, and lack of controlled-substance scheduling in the United States. Its disadvantages include sedation, anticholinergic effects, and limited suitability for chronic treatment in some populations.

Pruritus and allergy

Hydroxyzine competes with newer second-generation antihistamines such as cetirizine, loratadine, fexofenadine, and prescription therapies for specific inflammatory skin diseases. Newer agents generally have less sedation, which limits hydroxyzine’s first-line role for daytime allergy treatment.

Perioperative use

Hydroxyzine competes with other sedatives and antiemetic or anxiolytic protocols. Institutional demand depends on hospital formularies, procedure volume, and clinician preference.

Reimbursement

Commercial value is generally concentrated in volume, not price. Payers and pharmacies can substitute among approved generic suppliers. Brand Atarax has limited leverage unless a particular market, country, or distributor continues to recognize the brand.

Does Atarax face biosimilar risk?

No. Atarax contains a chemically synthesized small molecule, not a biologic. Biosimilar approval under the Public Health Service Act is not applicable.

The relevant competitors are generic drugs approved under the Federal Food, Drug, and Cosmetic Act. This distinction matters because biosimilar markets can preserve some manufacturer differentiation, while hydroxyzine is exposed to conventional generic price competition.[4]

What patent litigation and settlements affect Atarax?

No major current U.S. patent litigation or settlement agreement is central to Atarax’s commercial outlook. The product’s market matured after the period when branded manufacturers commonly used patent litigation and launch settlements to delay generic entry.

The absence of litigation does not eliminate legal risk. Manufacturers remain exposed to:

• FDA manufacturing actions;
• product-liability claims;
• labeling disputes;
• antitrust claims involving generic supply;
• state substitution laws; and
• contract disputes with wholesalers or institutional buyers.

Those risks are compliance and commercial risks rather than patent-exclusivity risks.

What licensing deals affect Atarax?

No major current licensing transaction is required to explain the U.S. hydroxyzine market. Legacy rights may have moved among brand owners, distributors, or authorized generic suppliers, but the commercial value of those arrangements is limited by generic competition.

A licensing deal could still matter in a specific country if it controls:

• a national Atarax trademark;
• an injectable formulation;
• a local registration;
• a hospital contract;
• a manufacturing site; or
• a distribution channel.

Such rights would create local commercial advantages, not broad global exclusivity.

What is Atarax’s revenue exposure and financial trajectory?

Atarax does not appear to be a separately reported material revenue driver for a large public pharmaceutical company. Public company filings generally report broad product categories or business segments rather than revenue from a legacy hydroxyzine brand.

The financial trajectory is therefore best described as follows:

Period	Financial profile
Original launch period	Branded prescription revenue with product differentiation
Genericization period	Declining brand share and increasing price pressure
Mature generic period	Low unit prices, fragmented supply, volume-based economics
Current market	Limited brand value; revenue concentrated among generic suppliers and distributors

The principal value drivers are product availability and cost structure. Tablets are likely to have the lowest margins because of simple manufacturing and broad supplier participation. Oral liquids can support better economics if supplier numbers are limited, but they require more quality-control infrastructure. Sterile products can have higher barriers but also higher compliance and capital requirements.

Atarax should not be modeled as a conventional branded-growth asset. A reasonable commercial model would treat hydroxyzine as a mature, low-growth generic category with:

• stable or declining nominal pricing;
• demand supported by chronic use in pruritus and recurrent prescribing for anxiety or sedation;
• low customer switching costs;
• modest volume growth tied to prescription trends;
• occasional price spikes during supply disruptions; and
• limited long-term margin expansion.

How does Atarax compare with Vistaril and generic hydroxyzine?

Factor	Atarax	Vistaril	Generic hydroxyzine
Salt	Hydroxyzine HCl	Hydroxyzine pamoate	HCl or pamoate
Brand strength	Legacy, limited current U.S. relevance	Legacy brand	Low brand differentiation
Patent protection	No meaningful current barrier	No meaningful current barrier	No meaningful current barrier
Generic competition	Established	Established	Core market
Main commercial risk	Brand obsolescence	Brand erosion	Price and supply competition
Market value	Limited	Limited	Volume-based
Biosimilar risk	None	None	None

Clinical substitution is not determined only by the shared hydroxyzine moiety. Dosage form, salt, labeled indication, strength, availability, and state pharmacy law affect substitution decisions.

What geographic coverage protects hydroxyzine?

Hydroxyzine has no single global patent position. Rights and market access vary by country based on:

• national product registrations;
• local trademarks;
• formulation approvals;
• manufacturing authorization;
• pharmacopoeial standards;
• import controls;
• reimbursement rules; and
• local generic competition.

The United States is a mature generic market. In other jurisdictions, an Atarax-branded product may retain greater visibility, but brand recognition does not necessarily indicate active patent protection. Local regulatory registrations and distribution arrangements may be more valuable than legacy patent rights.

Key Takeaways

• Atarax is the legacy brand associated with hydroxyzine hydrochloride.
• U.S. commercial activity is now concentrated in generic hydroxyzine products.
• The original molecule and core product rights are long expired.
• Atarax has no material current Orange Book exclusivity position.
• Paragraph IV litigation and patent settlements are not central to the market.
• Biosimilar competition does not apply because hydroxyzine is a small molecule.
• Oral liquids and sterile products have higher manufacturing barriers than tablets, but those barriers are not patent monopolies.
• Financial value is volume-based and depends on manufacturing cost, supply reliability, contracts, and dosage-form availability.
• Brand Atarax should be modeled as a mature or commercially inactive asset, not as a growth product.
• Generic hydroxyzine remains exposed to price erosion, supplier exits, and intermittent supply constraints.

FAQs

Is Atarax still sold in the United States?

The Atarax brand has limited current U.S. commercial relevance. Hydroxyzine hydrochloride remains available through generic products and may be supplied in different dosage forms.

Is hydroxyzine a controlled substance?

Hydroxyzine is not federally scheduled as a controlled substance in the United States. It can still cause substantial drowsiness and central nervous system depression.

Can generic hydroxyzine replace Atarax?

A pharmacist may substitute an approved generic equivalent when the dosage form, strength, salt, prescription instructions, and applicable state law permit substitution. Hydroxyzine hydrochloride and hydroxyzine pamoate are different salts and should not be treated as automatically interchangeable in every context.

Does hydroxyzine have pediatric exclusivity?

No current pediatric exclusivity period creates a meaningful commercial barrier for hydroxyzine. The product is a decades-old generic medicine.

Is hydroxyzine commercially attractive for pharmaceutical manufacturers?

Hydroxyzine is generally a low-margin product. It can be commercially viable for manufacturers with efficient production, dependable supply, institutional contracts, or less crowded dosage forms such as oral liquids. It is unlikely to support branded-drug economics.

References

1. U.S. Food and Drug Administration. (2019). Vistaril (hydroxyzine pamoate) prescribing information. FDA/DailyMed labeling database.

2. U.S. Food and Drug Administration. (n.d.). Discontinued drug product list. https://www.fda.gov/drugs/drug-approvals-and-databases/discontinued-drug-product-list

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

4. U.S. Food and Drug Administration. (n.d.). Biosimilars and interchangeable biosimilars. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars soliloquy

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