FEXOFENADINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for fexofenadine hydrochloride and what is the scope of patent protection?

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Chattem Sanofi, Barr, P And L, Taro, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Time Cap Labs, Contract Pharmacal, L Perrigo Co, Granules, Sciegen Pharms, Unique, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has forty-three patent family members in thirty-eight countries.

There are twenty-one drug master file entries for fexofenadine hydrochloride. One hundred and five suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for FEXOFENADINE HYDROCHLORIDE

International Patents:	43
US Patents:	1
Tradenames:	13
Applicants:	20
NDAs:	35
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	105
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	87
Patent Applications:	4,926
What excipients (inactive ingredients) are in FEXOFENADINE HYDROCHLORIDE?	FEXOFENADINE HYDROCHLORIDE excipients list
DailyMed Link:	FEXOFENADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE

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

Sponsor	Phase
Karuna Therapeutics	PHASE1
Abbisko Therapeutics Co, Ltd	PHASE1
Tanta University	PHASE2

See all FEXOFENADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		60MG;120MG	TABLET, EXTENDED RELEASE;ORAL
		60/120MG	TABLET, EXTENDED RELEASE; ORAL
		180MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FEXOFENADINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for FEXOFENADINE HYDROCHLORIDE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHILDREN'S ALLEGRA HIVES	Oral Suspension (OTC)	fexofenadine hydrochloride	30 mg/5 mL	201373	1	2010-01-25

US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	204097-002	Aug 19, 2016		OTC	No	No
Contract Pharmacal	FEXOFENADINE HYDROCHLORIDE	fexofenadine hydrochloride	TABLET;ORAL	219032-002	Feb 28, 2025		OTC	No	No
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011		OTC	Yes	No
Time Cap Labs	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	079112-005	Feb 8, 2012		OTC	No	No
Time Cap Labs	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	079112-001	Feb 8, 2012		OTC	No	No
Sun Pharm Inds	FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	091567-005	Feb 6, 2012		OTC	No	No
Rising	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	TABLET;ORAL	077081-005	Jul 21, 2011		DISCN	No	No

Expired US Patents for FEXOFENADINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-003	Jan 24, 2011
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-003	Jan 24, 2011
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-003	Jan 24, 2011
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006

International Patents for FEXOFENADINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Argentina	058323
Austria	E431137
Australia	2006326551
Brazil	PI0619895
Canada	2633086
China	101316580
Costa Rica	9993

Fexofenadine Hydrochloride market dynamics and financial trajectory (US/EU) Fexofenadine hydrochloride, a non-sedating H1 antihistamine, is a mature, mostly generic product with limited remaining patent exclusivity in key markets. Pricing is structurally constrained by high generic penetration, intense pharmacy and PBM competition, and routine formulary management. Commercial trajectory is driven more by volume retention in allergy seasons, OTC conversion/brand-capture dynamics, and label-positioning (adult vs pediatric dosing) than by durable innovation.

Which companies sell fexofenadine hydrochloride, and how competitive is the market?

Snapshot

Last updated: July 30, 2026

• Competitive set: multi-source generics plus OTC and brand-protected products depending on country and dosage form.
• Typical dynamics: 1) shelf and PBM substitution after generic entry, 2) seasonality spikes in spring and fall, 3) steady but modest unit growth where switch costs are low.

What dosage forms drive sales for fexofenadine hydrochloride?

• Tablets (commonly 30 mg, 60 mg, 120 mg, 180 mg)
• Orally disintegrating tablets (OTC and prescription equivalents vary by market)
• Suspension formulations exist in some pediatric lines
• Film-coated vs standard tablets do not change substitution economics materially, but OD tablets can support higher shelf share in certain retail channels.

Is the market brand-led or generic-led?

• In most jurisdictions, fexofenadine is generic-led.
• Brand advantage typically concentrates in:
  • specific lineups (OTC positioning, OD tablets)
  • consumer recognition during seasonal peaks
  • distribution relationships with major retailers

What drives fexofenadine hydrochloride demand through allergy seasons?

Demand engine

• Allergy seasonality: sales rise during high pollen periods and soften off-season.
• Indication stability: chronic allergic rhinitis and seasonal allergies are the core demand anchors.
• Switching behavior: low clinical barrier to generic H1 antihistamines supports rapid substitution.

How do comorbidities and competing H1s shape uptake?

• Many patients treat allergic rhinitis with a class of non-sedating H1 antihistamines (fexofenadine, loratadine, cetirizine, levocetirizine).
• Practical differentiators that affect share:
  • perceived sedation profile
  • onset and perceived efficacy
  • cost, copay, and formulary placement

What is the pricing structure in fexofenadine?

• Pricing tends to compress after each incremental generic entrant.
• Net price often reflects:
  • PBM rebates
  • contract pharmacy discounts
  • OTC retail promotions during peak months
• Higher priced formats (OD tablets) can maintain premium pricing in limited channels, but do not overcome generic substitution at scale.

When did generic entry reshape pricing, and what does that mean for revenue?

Core pattern

• Once multi-source generics fully saturate, revenue growth becomes constrained; competition shifts to share preservation rather than price.

How do OTC and prescription lanes interact?

• OTC availability can stabilize overall category volume even as prescription revenue erodes.
• Prescriber-driven revenue typically declines faster than retail volume after generic take-up, since OTC relies on consumer choice.

What financial trajectory is typical after full generic saturation?

• Unit sales may grow modestly with population and prescription-to-OTC shifts.
• Revenue typically declines in real terms due to pricing compression, with occasional short-term boosts from seasonal demand, packaging refresh cycles, or channel-specific contracts.

What is the regulatory and exclusivity status that affects commercialization?

Exclusivity

• Fexofenadine hydrochloride is generally not a high-stakes IP frontier product in most markets today.
• Commercial barriers skew toward:
  • formulation and brand/labeling differences by dosage form
  • manufacturing consistency and bioequivalence compliance
  • brand trade dress and OTC shelf strategy

What is the Orange Book status for fexofenadine hydrochloride in the US?

Direct status

• The drug has extensive generic history in the US; Orange Book listings historically include multiple patents and many generic approvals.
• Patent relevance in modern commercial planning is typically low versus competitive entry already completed.

How do FDA pathways influence competitive timing?

• After initial reference product eras, most entrants proceed via ANDA (generic) routes with bioequivalence requirements.
• For any remaining non-reference formats (e.g., OD tablets in specific strengths), approvals still generally flow through generic mechanisms where product composition and labeling support substitution.

What patent estate and litigation risk still matter for fexofenadine hydrochloride?

Commercial reality

• Any remaining patent tail effects are usually narrow and do not typically block category entry at scale.
• If litigation exists, its economic impact is often concentrated in:
  • specific strengths
  • specific dosage forms
  • method-of-use or formulation-change patents, where applicable

What patent types are most likely to affect commercialization?

• Formulation patents for special dosage forms (for example, OD tablet compositions) can delay specific competitors in a narrow slice of the market.
• Method-of-use patents would be less relevant for broadly established antihistamine allergy indications if claims have long since been designed around standard practice.

How does fexofenadine hydrochloride perform versus competing H1 antihistamines?

Competitive positioning

• Fexofenadine competes with:
  • loratadine
  • cetirizine
  • levocetirizine
  • desloratadine
• Typical market outcomes:
  • cetirizine often holds share due to efficacy perception across allergy and chronic urticaria
  • fexofenadine competes on “non-drowsy” positioning and dosing convenience (notably 180 mg once daily)
  • cost controls share more than pharmacology once generics dominate

What dosage and labeling choices help defend share?

• Adult once-daily dosing supports convenience-driven retention.
• Pediatric dosing availability affects formulary adoption in managed care and pediatric retail prescriptions.

What do financial trajectory metrics look like for fexofenadine?

Metric framework for this category Because the product is mature and generic-led, revenue trajectory is best analyzed using:

• category unit volume through OTC and prescription channels
• average net price (after rebates and discounts)
• seasonal sell-in and sell-through during peak allergy months
• share shifts by dosage form (OD vs standard tablets)
• formulary placement and PBM coverage tier changes

How sensitive is revenue to seasonal variation?

• High sensitivity during peak months drives quarterly volatility.
• Off-season troughs can make year-over-year comparisons noisy without volume normalization.

Where do margins typically come from now?

• For generic manufacturers: margins depend on plant cost position, scale, and rebate/contract terms.
• For branded/OTC variants: margin depends on consumer demand capture and retail promotional intensity.

What generic entry risks exist for fexofenadine hydrochloride by strength and form?

Entry risk profile

• Most strengths and standard tablets are already heavily multi-sourced.
• Incremental risks exist mainly where:
  • an OD tablet or pediatric suspension format has specific brand or patent remnants
  • manufacturing capacity constraints create supply stability premiums
  • localized channel competition differs by region

Which segments are most exposed?

• Common strengths with established ANDA history are highly exposed to ongoing price competition.
• Less common strengths or specialized formulations may show slower price erosion.

What manufacturing and supply dynamics affect commercial outcome?

Supply-chain drivers

• API and intermediate cost changes can influence gross margin quickly for generics.
• Regulatory and quality events (site inspections, batch rejections) can create temporary supply gaps and price dislocations.

What is the impact of contracting and supply exclusivity?

• Many generic makers rely on large contracts.
• When supply is disrupted, purchasers may pay temporary premiums, but long-term procurement reverts to lowest-cost qualified suppliers.

EU and UK: how do market dynamics differ from the US?

General pattern

• EU markets also show generic-led competition and seasonal demand.
• The main differences tend to be:
  • reimbursement structures
  • OTC coverage and consumer behavior
  • national variations in pack sizes and dispensing rules

How do reimbursement and copay policies affect uptake?

• In systems with tighter reimbursement controls, generics gain share quickly.
• In markets where OTC consumer choice dominates, branded positioning can matter more during seasonal demand surges.

Key commercial implications for investors, licensors, and litigators

Actionable takeaways

• The product’s economic profile is volume-share driven with limited pricing upside once generics saturate.
• IP-based monetization is likely concentrated in niche formulations, specific strengths, or brand-owned OTC assets rather than broad active-ingredient exclusivity.
• Licensing and litigation strategies should focus on:
  • specific product formats with defensible formulation or process differentiation
  • countries where competitive saturation is lower or where regulatory approval timelines create entry lags

Key Takeaways

• Fexofenadine hydrochloride is mature and primarily generic-led; pricing is structurally constrained by multi-source competition and PBM/pharmacy substitution.
• Financial trajectory is dominated by seasonality, channel mix (OTC vs prescription), and net pricing mechanics rather than durable exclusivity.
• Competitive differentiation is most visible in dosage-form positioning (notably OD tablets) and convenience-driven labeling (once-daily adult dosing).
• Remaining commercial upside is typically share preservation, contract wins, and cost-position advantages for generics, with limited broad-based IP leverage.

FAQs

1. How does OTC vs prescription status change the revenue resilience of fexofenadine hydrochloride?
2. Which dosage forms (tablets vs orally disintegrating) show the greatest price and share differentiation during allergy seasons?
3. What PBM coverage tier dynamics most affect net price for generic fexofenadine hydrochloride?
4. How quickly does market share usually shift after a new ANDA approval for fexofenadine hydrochloride?
5. What manufacturing or quality events most commonly cause short-term pricing dislocations in mature generic antihistamines like fexofenadine?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-30).
2. US FDA. ANDA (Abbreviated New Drug Application) information and regulatory framework. https://www.fda.gov/drugs/abbreviated-new-drug-applications-anda (accessed 2026-07-30).
3. EMA. European public assessment reports and product information for antihistamine medicines. European Medicines Agency. https://www.ema.europa.eu/ (accessed 2026-07-30).