List of Excipients in Branded Drug ALYQ

« Back to Dashboard

Generic Drugs Containing ALYQ

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	tadalafil	0093-3334	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA Inc	tadalafil	0093-3334	CROSCARMELLOSE SODIUM
Teva Pharmaceuticals USA Inc	tadalafil	0093-3334	FERRIC OXIDE RED

What are the Most Frequently-Used Excipients in ALYQ?

# Of NDCs	Excipient
2	CELLULOSE, MICROCRYSTALLINE
3	CROSCARMELLOSE SODIUM
2	FERRIC OXIDE RED

ALYQ Excipient Strategy and Commercial Opportunities: Formulation, Generic, and Patent Analysis

Last updated: November 6, 2026

ALYQ is Teva’s tadalafil 20 mg tablet for pulmonary arterial hypertension (PAH). Its excipient system is conventional, low-cost, and suitable for an immediate-release film-coated tablet. The strongest commercial opportunities are unlikely to come from exclusivity around the existing excipients. They are more likely to arise from differentiated tadalafil formulations, lactose-free or surfactant-reduced products, pediatric-friendly dosage forms, and supply-chain improvements for PAH treatment.

What is ALYQ and which excipients does it contain?

ALYQ contains tadalafil, a phosphodiesterase type 5 inhibitor, at a strength of 20 mg per tablet. It is indicated for the treatment of PAH to improve exercise ability and delay disease progression. The product is administered once daily, with the recommended dosage generally being 40 mg, taken as two 20 mg tablets, for adults with PAH. [1]

The ALYQ tablet contains a conventional tablet core and film coating.

Component	Function in ALYQ
Tadalafil	Active pharmaceutical ingredient
Lactose monohydrate	Diluent and tablet bulking agent
Croscarmellose sodium	Superdisintegrant
Hydroxypropyl cellulose	Binder and processing aid
Sodium lauryl sulfate	Wetting agent and dissolution aid
Magnesium stearate	Lubricant
Hypromellose	Film-forming coating polymer
Titanium dioxide	Opacifier and colorant
Talc	Coating aid and anti-tacking agent
Triacetin	Plasticizer
Yellow ferric oxide	Colorant

The excipient list is identified in the FDA-approved prescribing information and product labeling. [1] The formulation does not indicate a modified-release mechanism, enteric protection, or a specialized delivery platform.

What is the formulation profile of ALYQ?

ALYQ is an immediate-release, film-coated tablet. Its formulation strategy emphasizes:

• Adequate tadalafil wetting and dissolution
• Mechanical strength during manufacturing and distribution
• Rapid disintegration after oral administration
• Standard film-coating protection and identification
• Low-cost, scalable production

Tadalafil is practically insoluble in water. The inclusion of sodium lauryl sulfate helps improve wetting and can support reproducible dissolution. Croscarmellose sodium promotes tablet breakup, while hydroxypropyl cellulose supports granulation and tablet integrity.

The use of lactose monohydrate is commercially common but creates an opportunity for competing products aimed at patients or institutions seeking lactose-free formulations.

What commercial opportunities exist around ALYQ excipients?

The most credible opportunities involve formulation differentiation rather than direct substitution of one commodity excipient for another.

1. Lactose-free tadalafil tablets

A lactose-free version could replace lactose monohydrate with mannitol, microcrystalline cellulose, dibasic calcium phosphate, spray-dried mannitol, or a co-processed excipient system.

Potential commercial benefits include:

• Use in patients with lactose intolerance or excipient sensitivity
• Simplified hospital formulary selection
• Better positioning for specialty pharmacies
• Reduced dependence on dairy-derived excipients
• Potential compatibility with vegan or allergen-control policies

A lactose-free product would still need to demonstrate bioequivalence or otherwise satisfy the applicable FDA pathway. Changing the diluent can alter tablet hardness, disintegration, dissolution, content uniformity, and stability.

2. Sodium-lauryl-sulfate-reduced or surfactant-free formulations

Sodium lauryl sulfate is widely used in oral solid dosage forms, but it can create concerns related to gastrointestinal tolerability, patient perception, and compatibility with certain manufacturing processes.

A competing tadalafil product could use:

• Poloxamers
• Sodium dodecylbenzenesulfonate alternatives
• Wetting agents with lower irritation potential
• Micronized tadalafil
• Amorphous solid dispersions
• Spray-dried or hot-melt-extruded tadalafil systems

The technical challenge is maintaining rapid and consistent dissolution because tadalafil has low aqueous solubility. A lower-surfactant formulation would need a robust dissolution profile across physiologic pH conditions and after accelerated stability testing.

3. Pediatric-friendly dosage forms

PAH treatment can involve younger patients, although ALYQ labeling is directed to adults. A pediatric formulation could provide a commercial niche through:

• Oral granules
• Powder for reconstitution
• Oral suspension
• Mini-tablets
• Orally disintegrating tablets
• Lower-strength tablets

Taste masking would be a central development issue. Tadalafil has a bitter taste, and a liquid product would require a preservative, flavor system, viscosity modifier, and container-closure system.

Potential excipients include:

• Sucralose or acesulfame potassium for sweetness
• Fruit flavor systems
• Xanthan gum or hydroxyethyl cellulose for suspension control
• Sodium benzoate or potassium sorbate for preservation
• Polysorbates or poloxamers for wetting
• Buffer systems to maintain pH and stability

The regulatory route would depend on the proposed formulation, labeling, reference product, and whether the product is positioned as a generic equivalent or a differentiated 505(b)(2) product.

4. Orally disintegrating tadalafil products

An orally disintegrating tablet could target patients with swallowing difficulties or those requiring more convenient administration.

A typical platform might use:

• Mannitol as a soluble filler
• Crospovidone or croscarmellose sodium as a disintegrant
• Low-substitution hydroxypropyl cellulose
• Direct-compression excipient systems
• Flavoring and taste-masking agents
• A low-dose lubricant system

The principal risks are bitter taste, tablet friability, moisture sensitivity, and incomplete disintegration. A successful ODT would need to provide rapid oral dispersion without compromising tadalafil dissolution or increasing dose variability.

An ODT could support a 505(b)(2) strategy if it cannot qualify as an ordinary ANDA equivalent to ALYQ. It could also generate formulation patents directed to taste masking, particle engineering, excipient ratios, or manufacturing conditions.

What patents protect ALYQ and tadalafil formulations?

ALYQ’s commercial position is based primarily on tadalafil’s established active-ingredient and PAH product history, not on a visibly differentiated excipient platform.

The relevant patent categories include:

Patent category	Commercial relevance
Tadalafil compound patents	Protect the active pharmaceutical ingredient
PAH method-of-use patents	Cover use of tadalafil in pulmonary hypertension
Solid-form patents	Protect crystalline or amorphous tadalafil forms
Formulation patents	Cover dissolution enhancement, dosage forms, or excipient systems
Manufacturing patents	Cover particle size, granulation, coating, or process controls
Device or packaging patents	More relevant to liquid, dispersible, or combination products

Cialis, the tadalafil product for erectile dysfunction and benign prostatic hyperplasia, has a different commercial indication from ALYQ. The existence of Cialis-related patent rights does not mean that every tadalafil PAH formulation remains blocked by the same patents. Patent scope depends on claim language, expiration, terminal disclaimers, patent-term adjustments, and listing status.

A complete freedom-to-operate opinion would require a current review of:

• FDA Orange Book listings
• U.S. Patent and Trademark Office records
• Patent assignments and continuation practice
• Paragraph IV notices
• Federal court dockets
• Relevant foreign patent families
• Any settlement or license agreements

No confirmed ALYQ-specific excipient patent can be established from the product label alone. The listed excipients are standard pharmaceutical materials and are unlikely, by themselves, to create meaningful composition-of-matter exclusivity.

What is the FDA regulatory status of ALYQ?

ALYQ is an FDA-approved tadalafil product for PAH. FDA labeling identifies it as a 20 mg film-coated tablet. [1]

Regulatory element	ALYQ position
Active ingredient	Tadalafil
Dosage form	Immediate-release film-coated tablet
Strength	20 mg
Therapeutic area	Pulmonary arterial hypertension
FDA status	Approved
Administration	Oral, once daily
Commercial dose	Commonly 40 mg daily, administered as two 20 mg tablets
Reference-product issue	Depends on the applicable FDA application and product-specific pathway

An important commercial distinction is whether a competitor is seeking approval as:

1. A conventional ANDA generic;
2. A 505(b)(2) product with a materially different formulation or dosage form; or
3. A new NDA for a differentiated tadalafil product.

A conventional immediate-release tadalafil tablet with the same strength and route may be suitable for an ANDA pathway if the reference-product and product-specific requirements are satisfied. A liquid, ODT, pediatric formulation, or novel dissolution-enhanced product may require a different regulatory strategy.

When does ALYQ lose exclusivity?

ALYQ’s exclusivity position must be separated into FDA regulatory exclusivity and patent protection.

FDA approval of a generic or competing tadalafil product depends on the relevant reference listed drug, applicable patents, exclusivity periods, and any litigation or settlement terms. The product label alone does not establish the precise date on which all commercial exclusivity ends.

For business planning, the key questions are:

• Which patents are listed against the applicable tadalafil reference product?
• Are any patents directed specifically to the PAH method of use?
• Are there unlisted patents that could support litigation?
• Has a generic applicant submitted a Paragraph IV certification?
• Has a court imposed a stay or injunction?
• Does an agreement restrict the generic launch date?
• Is the competing product a true equivalent or a differentiated dosage form?

Because ALYQ uses an established active ingredient and conventional tablet technology, the main generic-entry risk is likely to arise from standard ANDA competition rather than a technically difficult biosimilar pathway.

Does ALYQ have biosimilar risk?

No. ALYQ contains a chemically synthesized small-molecule drug, tadalafil. Biosimilar rules under the Biologics Price Competition and Innovation Act do not apply. Competitive products would be generics, authorized generics, or differentiated tadalafil products approved through an NDA or 505(b)(2) pathway.

How strong is the ALYQ excipient patent estate?

The excipient patent estate appears limited from a formulation-strategy perspective.

Strengths

• The formulation is simple and commercially reproducible.
• The excipients are widely available.
• The tablet architecture is familiar to generic manufacturers.
• Standard excipient sourcing supports low manufacturing costs.
• No specialized device is required.

Weaknesses

• Commodity excipients are difficult to protect broadly.
• Lactose, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, and standard coating materials are widely used.
• A competitor can often design around the listed excipients.
• The formulation does not create an obvious high barrier to ANDA development.
• Excipient substitution may be possible without changing the therapeutic concept.

A stronger patent position would require a defensible technical relationship between the excipients and a measurable benefit, such as improved tadalafil bioavailability, reduced food effect, enhanced stability, superior dissolution, lower variability, or improved pediatric acceptability.

What formulation patents could protect a next-generation tadalafil product?

The most commercially relevant claim areas are likely to include:

Dissolution-enhancing formulations

Claims could cover tadalafil particle size, amorphous content, solid dispersions, surfactant combinations, or polymer matrices that improve dissolution.

Taste-masked oral products

Claims could cover coated tadalafil particles, ion-exchange complexes, polymeric barriers, lipid matrices, or multi-layer dosage forms.

Pediatric liquid formulations

Claims could target pH, preservative systems, suspension stability, particle-size distribution, viscosity, sedimentation control, and dosing accuracy.

Orally disintegrating tablets

Claims could cover excipient ratios, tablet porosity, compression force, disintegration time, taste masking, and moisture protection.

Fixed-dose or combination products

A tadalafil product combined with another PAH therapy could create a larger commercial opportunity, but it would require clinical, regulatory, and patent analysis for each active ingredient. Combination products could face substantial development and reimbursement barriers.

Which companies are likely to challenge ALYQ commercially?

The likely competitive field includes:

• Generic tadalafil manufacturers
• Authorized-generic suppliers
• Specialty pharmaceutical companies focused on PAH
• Contract development and manufacturing organizations
• Companies developing pediatric or liquid dosage forms
• Manufacturers of differentiated oral solid dosage platforms

The most credible first-wave competitors are conventional tadalafil tablet manufacturers because they can rely on mature API sourcing and established manufacturing processes. Differentiated entrants would likely compete through formulation convenience, lower excipient burden, improved supply reliability, or contracting terms rather than clinical superiority.

What generic launch scenarios exist for ALYQ?

Launch scenario	Commercial effect	Primary barrier
Conventional 20 mg tablet	Rapid price erosion and formulary substitution	Patent and regulatory timing
Lactose-free tablet	Niche differentiation with modest premium potential	Demonstrating equivalence and securing demand
ODT	Convenience positioning	Taste masking and stability
Oral suspension	Pediatric and swallowing-difficulty niche	Dose uniformity, preservation, and packaging
Authorized generic	Lower-risk channel expansion	Supply agreement and margin compression
Combination product	Potential adherence benefit	Clinical development and reimbursement
Regional contract supply	Improved access and tender participation	Manufacturing qualification and logistics

A conventional generic launch would likely produce the fastest revenue impact. A differentiated dosage form could preserve margin but would require additional development and marketing investment.

What manufacturing and intellectual-property barriers matter most?

The most important manufacturing barriers are technical rather than patent-based.

API control

Tadalafil particle size, polymorphic form, bulk density, and impurity profile can affect blend uniformity and dissolution. API qualification is central to a successful generic or reformulated product.

Dissolution reproducibility

The formulation must maintain acceptable dissolution across batches. Variability in sodium lauryl sulfate, lubricant level, compression force, or granulation endpoint can affect performance.

Coating consistency

Film-coating weight gain, pigment distribution, and tablet appearance affect product identification and stability. These are manageable but require validated process controls.

Supply-chain resilience

Commercial opportunities exist for manufacturers that can provide dual-source excipient supply, validated alternative grades, and reliable tadalafil API capacity. This matters in hospital and specialty-pharmacy channels where stockouts can cause treatment interruptions.

Geographic coverage

U.S. market entry requires FDA compliance and applicable patent clearance. European and other markets may involve separate patent families, national litigation, supplementary protection certificates, pediatric requirements, and local substitution rules. A global excipient strategy should account for regional differences in approved colorants, labeling requirements, and excipient acceptability.

What licensing deals and settlement agreements affect ALYQ?

No specific ALYQ excipient license or settlement agreement is established by the product label. Commercial diligence should distinguish between:

• Licenses covering tadalafil compound rights;
• Licenses covering PAH methods of use;
• Agreements involving Cialis or other tadalafil products;
• Generic launch settlements;
• Authorized-generic supply arrangements;
• Manufacturing or API supply agreements.

A settlement may permit an earlier launch without eliminating patent risk for all products. Its terms may apply only to a particular applicant, dosage form, indication, or market.

Key Takeaways

• ALYQ is a 20 mg immediate-release tadalafil film-coated tablet for PAH.
• Its excipient system is conventional and includes lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate, and standard coating materials.
• The existing excipients provide manufacturing functionality but limited standalone patent differentiation.
• The strongest formulation opportunities are lactose-free tablets, surfactant-reduced products, ODTs, pediatric suspensions, and lower-strength dosage forms.
• Generic competition is more relevant than biosimilar competition because tadalafil is a small-molecule drug.
• A conventional tablet is most compatible with an ANDA strategy; differentiated dosage forms may require a 505(b)(2) application or NDA.
• The most defensible future patents would link excipient selection to improved dissolution, bioavailability, taste, stability, or dosing performance.
• Commercial value is likely to depend on launch timing, reimbursement, specialty-pharmacy access, supply reliability, and patent clearance rather than excipient novelty alone.

FAQs

Is ALYQ lactose-free?

No. The FDA labeling identifies lactose monohydrate as an excipient in the ALYQ tablet. [1]

Can a company make a tadalafil tablet without sodium lauryl sulfate?

Yes, but the replacement system must preserve tadalafil dissolution, content uniformity, stability, and bioequivalence or satisfy the applicable requirements for a differentiated product.

Is ALYQ the same as Cialis?

No. Both contain tadalafil, but ALYQ is labeled for PAH while Cialis is labeled for erectile dysfunction and benign prostatic hyperplasia. Their regulatory, patent, and commercial positions must be analyzed separately.

Would a pediatric tadalafil suspension qualify as a generic?

Not necessarily. A materially different dosage form may require a 505(b)(2) application or another regulatory pathway rather than a conventional ANDA.

Can excipient changes create new patent protection for tadalafil?

Yes, if the formulation produces a defensible technical result and the claims cover a novel, non-obvious composition or process. Simply replacing one common filler with another is unlikely to create strong, durable exclusivity.

References

1. U.S. Food and Drug Administration. (2019). ALYQ (tadalafil) tablets, for oral use: Prescribing information. Teva Pharmaceuticals USA, Inc.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.
3. U.S. Food and Drug Administration. (n.d.). ANDA submissions: Generic drug products. FDA.