List of Excipients in Branded Drug CONSENSI

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	CROSCARMELLOSE SODIUM	2038-06-14
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	MAGNESIUM STEARATE	2038-06-14
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	MANNITOL	2038-06-14
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	POVIDONE K30	2038-06-14
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	SILICON DIOXIDE	2038-06-14
Burke Therapeutics LLC	CONSENSI	amlodipine besylate and celecoxib	69101-502	SODIUM LAURYL SULFATE	2038-06-14

Consensi Excipient Strategy and Commercial Opportunities

Last updated: August 31, 2026

Consensi is a fixed-dose combination of celecoxib and amlodipine besylate approved by the FDA for adults who require treatment for osteoarthritis pain and hypertension. Its commercial value depends less on novel excipients than on dose-combination protection, tablet manufacturability, bioequivalence control, and the ability to reduce pill burden for patients receiving both therapies.

The primary excipient opportunity is a robust immediate-release formulation that preserves celecoxib dissolution, avoids amlodipine degradation, supports high-volume generic manufacturing, and remains acceptable across global regulatory markets. The largest commercial opportunities are authorized-generic supply, regional licensing, lifecycle extensions, and differentiated combination products rather than premium pricing for excipient innovation alone.

What is Consensi and how does its formulation work?

Consensi contains celecoxib, a selective cyclooxygenase-2 inhibitor, and amlodipine besylate, a dihydropyridine calcium-channel blocker. The FDA-approved strengths are 5 mg/200 mg and 10 mg/200 mg tablets.[1]

The product combines two separate therapeutic functions:

Component	Role	Key formulation issue
Celecoxib	Reduces osteoarthritis pain and inflammation	Poor aqueous solubility and dissolution sensitivity
Amlodipine besylate	Lowers blood pressure	Low-dose uniformity, stability, and blend-content control
Tablet matrix	Delivers both actives in one immediate-release unit	Balancing dissolution, hardness, friability, and manufacturability

Celecoxib is a BCS Class II-type formulation challenge because solubility can limit dissolution and absorption. Amlodipine is administered at a much lower mass than celecoxib, creating content-uniformity and segregation risks. A successful formulation must therefore accommodate a 40-fold difference between the 5 mg amlodipine dose and the 200 mg celecoxib dose.

The product is not a modified-release system. Excipient selection should support rapid and reproducible immediate release rather than prolonged delivery.

What excipients are used in Consensi tablets?

The FDA labeling identifies conventional tablet excipients, including microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, and magnesium stearate. The tablets also use a film-coating system.[1]

Excipient class	Likely functional role in Consensi	Commercial relevance
Microcrystalline cellulose	Diluent, dry binder, compression aid	Supports tablet strength and direct compression
Croscarmellose sodium	Superdisintegrant	Helps offset celecoxib’s dissolution limitations
Povidone	Binder and granulation aid	Improves blend cohesion and tablet robustness
Sodium lauryl sulfate	Wetting and surfactant function	Can improve celecoxib wetting and dissolution
Magnesium stearate	Lubricant	Controls ejection force, with over-lubrication risk
Film-coating excipients	Appearance, handling, swallowability, protection	Allows color and product differentiation

The commercial formulation strategy is conventional rather than excipient-proprietary. That is valuable for manufacturing because the listed materials are broadly available, compendial, and familiar to contract manufacturers. It also limits barriers to generic substitution.

How should an excipient strategy address celecoxib solubility?

The central technical problem is celecoxib dissolution. A formulation developer should prioritize wetting, particle-size control, and rapid disintegration before pursuing a complex enabling technology.

Surfactant and wetting control

Sodium lauryl sulfate can improve wetting of hydrophobic celecoxib particles. Its concentration must be controlled because excessive surfactant can affect tablet mechanical properties, dissolution profiles, gastrointestinal tolerability, and impurity behavior.

Alternative surfactants, including poloxamers and sodium docusate, may create formulation opportunities, but they also increase regulatory differentiation requirements. A generic manufacturer would generally prefer the established excipient system unless a meaningful dissolution or stability advantage exists.

Disintegrant selection

Croscarmellose sodium supports rapid tablet breakup. Crospovidone and sodium starch glycolate are potential substitutes, but they can produce different water uptake, swelling, and dissolution behavior. A substitution strategy must control:

• Disintegration time
• Celecoxib dissolution at multiple pH levels
• Amlodipine release
• Tablet hardness and friability
• Stability under humidity
• Content uniformity across commercial-scale batches

Particle-size and solid-state control

Particle-size distribution can materially affect celecoxib dissolution. A generic or reformulated product may obtain more value from micronization, narrow particle-size specifications, or improved blending than from a novel excipient.

Solid-state characterization should evaluate polymorphism, crystallinity, amorphous content, and possible drug-excipient interactions. These controls are relevant to both formulation performance and manufacturing reproducibility.

What excipient strategy addresses amlodipine content uniformity?

Amlodipine is present at a low dose relative to celecoxib. The formulation therefore requires strong controls against segregation and poor blend uniformity.

A practical development approach uses:

1. A preblend or ordered-addition process for amlodipine.
2. A carrier-based dilution step with microcrystalline cellulose or another compatible diluent.
3. Controlled particle-size matching between amlodipine-containing premix and the main blend.
4. Low-shear blending after lubricant addition.
5. In-process blend sampling at multiple locations and times.
6. Validated content-uniformity testing under commercial-scale conditions.

Granulation may improve uniformity but can introduce moisture and heat exposure. Direct compression is simpler and more economical, but it places greater demands on particle engineering and mixing validation.

The principal excipient opportunity is therefore not a new ingredient. It is a better premix, better particle engineering, or a more reproducible manufacturing process.

What formulations are protected by Consensi patents?

Consensi’s intellectual-property position is centered on the combination of celecoxib and amlodipine, including pharmaceutical compositions and related therapeutic use claims. Public patent records identify U.S. patents directed to compositions containing the two active ingredients, including U.S. Patent No. 8,501,951.[2]

IP category	Relevance to Consensi	Generic risk
Fixed-dose composition claims	Protect co-formulation of celecoxib and amlodipine	High if claims cover broad ratio or strength ranges
Method-of-use claims	May cover treating hypertension and pain with the combination	Potential Paragraph IV exposure
Formulation claims	May address excipient, dosage-form, or release characteristics	Depends on claim construction and listing status
Manufacturing claims	May cover blending, granulation, or tablet production	Usually narrower and harder to enforce commercially
Trademark rights	Protect the Consensi brand	Do not block an ANDA approved under a different name

A freedom-to-operate review must distinguish claims that cover the active-ingredient combination from claims limited to specific excipient systems or manufacturing steps. A generic product that uses different excipients may avoid a narrow formulation claim while still infringing broader composition or method-of-use claims.

Patent expiration must be assessed from current USPTO and FDA Orange Book records rather than inferred solely from the issue date. Patent-term adjustment, terminal disclaimers, pediatric exclusivity, and any later-listed patents can change the commercial entry analysis.[3][4]

What is the Orange Book status of Consensi?

Consensi was approved under NDA 210991 in May 2018.[1][5] FDA approval established the product’s regulatory reference status for an abbreviated new drug application, subject to the applicable patent and exclusivity certifications.

The Orange Book analysis should cover:

• Listed patents for NDA 210991
• Patent expiration dates and pediatric extensions
• Whether any patent is eligible for Paragraph IV certification
• Whether method-of-use patents require a Section viii statement
• Whether the FDA has assigned 3-year new clinical investigation exclusivity
• Whether any exclusivity period has expired

A fixed-dose combination approved under a 505(b)(2) pathway can present a different patent and exclusivity profile from a conventional single-ingredient new chemical entity. The applicant’s clinical and formulation work may support regulatory exclusivity even when both active ingredients are individually generic.

When does Consensi lose exclusivity?

Consensi’s market protection is divided between regulatory exclusivity and patents.

The product received FDA approval in 2018. Any 3-year exclusivity associated with new clinical investigations would have run from approval and would not ordinarily remain a major barrier to current ANDA filing activity. Patent protection can last longer, particularly where composition or use patents were filed after the initial combination-development work.

The commercial entry date depends on:

• The latest enforceable patent expiration
• Whether an ANDA applicant files a Paragraph IV certification
• Whether the patent holder files infringement litigation within 45 days
• The timing of FDA tentative and final approval
• Any settlement or license terms
• Whether a first Paragraph IV applicant qualifies for 180-day exclusivity

No reliable launch date should be inferred from the original 2018 approval date. The relevant date is the earliest legally available ANDA launch date after accounting for Orange Book listings and litigation.

Which companies are challenging Consensi patents?

Consensi has not developed the level of public litigation visibility associated with major blockbuster products. Publicly available records should be reviewed for ANDA notices, Hatch-Waxman complaints, district-court docket activity, and Paragraph IV settlements.

Potential challengers are more likely to include large generic manufacturers with existing celecoxib and amlodipine manufacturing capabilities. Relevant candidate profiles include companies that already market:

• Generic celecoxib capsules
• Generic amlodipine tablets
• Fixed-dose cardiovascular combinations
• High-volume immediate-release tablets

The technical barrier is moderate. The legal barrier may be higher if broad combination claims remain enforceable. A company can reduce formulation risk through a non-infringing excipient system, but it cannot avoid a broad active-ingredient composition claim merely by changing the tablet matrix.

What generic entry risks exist for Consensi?

Generic entry risk is meaningful because both active ingredients are mature, widely manufactured products. The principal risks are commercial and legal rather than scientific.

Regulatory risk

A generic applicant must demonstrate bioequivalence to the reference product for both actives. The applicant may face dissolution sensitivity because celecoxib performance can vary with particle size, wetting, and formulation composition.

Manufacturing risk

The formulation has a low-dose/high-dose combination. Scale-up can generate:

• Amlodipine segregation
• Blend-uniformity failures
• Lubrication variability
• Celecoxib dissolution drift
• Tablet hardness changes
• Coating defects

Legal risk

A Paragraph IV challenge could trigger litigation and a 30-month stay of FDA approval, depending on the timing and scope of the patent listing.[4] A Section viii carve-out may be available for certain method-of-use claims, but it does not eliminate exposure to composition claims.

Commercial risk

The market may be limited because physicians can prescribe generic celecoxib and generic amlodipine separately at low cost. The fixed-dose product must demonstrate adherence, convenience, or payer value to justify a price premium.

How large is the commercial opportunity for Consensi?

The addressable market includes adults with osteoarthritis who also require antihypertensive treatment. The population is clinically relevant, but the product competes against separate generic prescriptions.

The opportunity is strongest in four segments:

Segment	Opportunity	Constraint
Adherence-focused patients	One tablet instead of two	Limited if patients require dose changes
Primary-care prescribing	Simplifies treatment for dual conditions	Physicians may prefer titratable components
Value-based care	Potential reduction in pill burden and prescription complexity	Payers may demand generic pricing
International markets	Combination products may have stronger convenience value	Country-specific registration and patent rules

Consensi has a structural limitation: amlodipine often requires titration, while celecoxib dosing may change based on pain severity, duration, cardiovascular risk, and renal or gastrointestinal considerations. A fixed-dose product is therefore most useful for patients already stable on both ingredients at compatible doses.

Publicly reported product-specific revenue has been limited compared with leading celecoxib and cardiovascular brands. The commercial case should be underwritten on targeted uptake, licensing economics, and manufacturing cost rather than blockbuster assumptions.

How does Consensi compare with separate celecoxib and amlodipine?

Factor	Consensi	Separate generic products
Pill burden	One tablet	Two dosage units
Dose flexibility	Limited to available fixed strengths	High
Formulation complexity	Higher	Lower per product
Generic competition	Combination-specific	Extensive
Prescribing convenience	Higher for stable patients	Higher when titration is needed
Payer economics	May require value justification	Usually lowest-cost option
Excipient differentiation	Possible but limited	Mature and standardized

Consensi has a convenience advantage but a dose-flexibility disadvantage. That trade-off restricts adoption to patients whose celecoxib and amlodipine requirements remain stable.

What licensing deals and partnerships could support Consensi?

The most practical licensing models are:

Regional commercialization licenses

A regional partner can obtain rights in markets where combination prescribing is common and where the licensee already sells cardiovascular or pain medicines. The agreement should allocate responsibility for local registration, pharmacovigilance, pricing, and patent enforcement.

Authorized-generic arrangements

An authorized generic can preserve channel access after patent expiry and reduce the impact of an independent ANDA launch. The model is commercially attractive if the product has established prescriber recognition or payer contracts.

Formulation sublicensing

A formulation partner could license a differentiated excipient system, such as a lower-surfactant formulation, improved dissolution profile, or enhanced stability package. This is most valuable if the formulation supports a separate patent or a material cost reduction.

Combination-product expansion

The platform could support additional strengths or related products, but each new strength must address dose flexibility, clinical positioning, and regulatory bridging. A higher-amlodipine or lower-celecoxib strength could improve titration utility, subject to development and approval requirements.

How strong is the Consensi patent estate?

The estate is strategically stronger than the excipient position because the active-ingredient combination is the core differentiator. Its practical strength depends on claim breadth, prosecution history, validity defenses, Orange Book listing status, and whether claims cover the marketed strengths.

Patent strength should be evaluated across five dimensions:

1. Breadth of the composition claims.
2. Coverage of both 5 mg and 10 mg amlodipine strengths.
3. Coverage of celecoxib dose ranges beyond 200 mg.
4. Vulnerability to obviousness and written-description challenges.
5. Availability of non-infringing fixed-dose alternatives.

A composition patent that covers a broad celecoxib-amlodipine combination can create meaningful entry risk. A patent limited to a narrow formulation or specific excipient ratio is easier to design around.

What manufacturing and IP barriers affect commercial entry?

Manufacturing barriers are manageable for experienced generic companies. Both active ingredients have established supply chains, and the tablet uses standard excipients. The highest technical burden is achieving consistent celecoxib dissolution and amlodipine content uniformity at commercial scale.

The more significant barrier may be regulatory and legal coordination. An entrant must align:

• Active pharmaceutical ingredient qualification
• Excipient vendor controls
• Process validation
• Dissolution method development
• Bioequivalence strategy
• Patent certification
• Labeling carve-outs
• Commercial launch timing

Geographic expansion also requires separate analysis. U.S. Orange Book patents do not automatically control Europe, Canada, Japan, or emerging markets. Patent term, combination-product approval standards, substitution rules, and reimbursement policy vary by country.

Key Takeaways

• Consensi is a fixed-dose tablet containing celecoxib 200 mg and amlodipine besylate 5 mg or 10 mg.
• The formulation uses conventional excipients, including microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, and magnesium stearate.
• The principal formulation challenge is celecoxib dissolution combined with low-dose amlodipine content uniformity.
• Excipient innovation can improve manufacturability and dissolution, but active-ingredient combination patents are likely more commercially important.
• Generic entry risk is moderate technically and potentially significant legally.
• The main commercial opportunity is targeted adherence improvement, regional licensing, and authorized-generic supply.
• Separate generic celecoxib and amlodipine remain strong competitors because they provide greater dose flexibility and lower cost.
• Consensi’s market opportunity is limited by the need for patients to remain stable on compatible doses of both medicines.

FAQs

Can a generic manufacturer avoid Consensi patents by changing the excipients?

Only if the relevant patent claims are limited to the original excipient system. A broad composition claim covering celecoxib and amlodipine would not be avoided merely by replacing croscarmellose sodium or sodium lauryl sulfate.

Is Consensi an extended-release product?

No. Consensi is an immediate-release fixed-dose tablet. The formulation objective is rapid, reproducible release of both active ingredients.

Could a co-crystal or amorphous celecoxib formulation compete with Consensi?

Yes. A different solid form or enabling formulation could improve dissolution or stability, but it would require separate pharmaceutical development, regulatory support, and patent analysis.

Does Consensi have biosimilar competition?

No. Consensi is a small-molecule combination product, not a biologic. Competition would arise through ANDAs, 505(b)(2) products, or non-U.S. generic pathways rather than biosimilar applications.

Is a low-cost two-pill regimen a substitute for Consensi?

Yes. Generic celecoxib and amlodipine can provide a lower-cost and more flexible alternative. Consensi’s value depends on whether one-tablet convenience improves adherence enough to justify its incremental cost.

References

1. U.S. Food and Drug Administration. (2018). Consensi (celecoxib and amlodipine besylate) tablets, prescribing information.
2. United States Patent and Trademark Office. (2013). U.S. Patent No. 8,501,951, pharmaceutical compositions comprising celecoxib and amlodipine.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application approvals, patent certifications, and 30-month stays under the Hatch-Waxman Amendments.
5. U.S. Food and Drug Administration. (2018). Approval letter for NDA 210991, Consensi.