List of Excipients in Branded Drug VERELAN PM

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Lannett Company Inc	VERELAN PM	verapamil hydrochloride	62175-570	D&C RED NO. 28
Lannett Company Inc	VERELAN PM	verapamil hydrochloride	62175-570	FD&C BLUE NO. 1
Lannett Company Inc	VERELAN PM	verapamil hydrochloride	62175-570	FD&C RED NO. 40
Lannett Company Inc	VERELAN PM	verapamil hydrochloride	62175-570	FUMARIC ACID

Verelan PM Excipient Strategy and Commercial Opportunities

Last updated: July 31, 2026

Verelan PM is an extended-release oral capsule containing verapamil hydrochloride, a calcium-channel blocker used primarily for hypertension and angina. Its commercial value is tied to multiparticulate delivery, dose flexibility, predictable overnight exposure, and the opportunity to manufacture an equivalent extended-release product without reproducing the brand’s exact excipient composition.

The strongest opportunities are generic substitution, private-label supply, low-cost capsule manufacturing, and differentiated modified-release products. The main technical barrier is release-rate control rather than the active ingredient itself.

What is Verelan PM and how does its dosage form work?

Verelan PM is a once-daily, extended-release capsule. The product uses multiple drug-containing pellets or beads enclosed in a hard gelatin capsule. The multiparticulate system is designed to release verapamil over an extended period after administration, with dosing at bedtime to support blood-pressure control during the early morning period.[1]

Attribute	Verelan PM profile
Active ingredient	Verapamil hydrochloride
Therapeutic class	Calcium-channel blocker
Dosage form	Extended-release capsule
Strengths historically marketed	100 mg, 200 mg, and 300 mg
Route	Oral
Release technology	Multiparticulate modified-release beads or pellets
Typical administration	Once daily, generally at bedtime
Primary commercial pathway	ANDA for a therapeutically equivalent generic
Main technical issue	Reproducing dissolution and in-vivo release behavior

Verelan PM differs from immediate-release verapamil tablets and from other extended-release verapamil products. A generic manufacturer must establish equivalence to the relevant reference listed drug, including dosage form, strength, route, release characteristics, and labeling requirements.

What excipients are used in Verelan PM?

The key excipient strategy is a coated-pellet system. Public labeling identifies excipients associated with the capsule and modified-release structure, including sugars or sugar spheres, polymeric coating materials, binders, glidants, lubricants, capsule materials, and colorants.[1,2]

The exact commercial formulation can vary by manufacturing site and labeling revision. The principal functional excipient categories are as follows:

Excipient category	Likely function in the product
Sugar spheres or inert cores	Provide a substrate for drug-layer application
Povidone or another binder	Adheres verapamil to the pellet core
Ethylcellulose or similar water-insoluble polymer	Controls diffusion and prolongs release
Hypromellose	Supports film formation, pore formation, or release modulation
Talc	Prevents pellet agglomeration and improves coating processability
Titanium dioxide and colorants	Capsule identification and light protection
Gelatin or hypromellose capsule shell	Encapsulates the multiparticulate dose
Pharmaceutical-grade solvents and processing aids	Used during drug-layering and film coating, with residual limits controlled under applicable standards

The commercial importance of these materials is functional, not merely compositional. A small change in polymer grade, particle size, coating weight, plasticizer concentration, or pellet porosity can shift the dissolution profile.

Which excipients control Verelan PM release?

The release-controlling layer is the central intellectual-property and manufacturing element. Water-insoluble polymers, especially ethylcellulose-type coatings, can create a diffusion barrier around drug-loaded pellets. Hypromellose and pore-forming materials can modify water penetration and drug diffusion.

Important process variables include:

• Drug-layer thickness on the inert core
• Polymer-to-pore-former ratio
• Coating weight gain
• Polymer viscosity grade
• Pellet size distribution
• Bed temperature during coating
• Spray rate and atomization
• Drying conditions
• Capsule fill weight
• Compression or handling stress during downstream processing

A manufacturer can use the same broad excipient classes as the reference product while selecting different grades and process conditions. The objective is to match clinically relevant release behavior, not necessarily to duplicate the proprietary formulation.

What formulation patents protect Verelan PM?

Verelan PM’s original commercial protection was based on a combination of drug-product, modified-release, and potentially method-of-use rights. The relevant patent categories are more important than any single excipient patent:

1. Multiparticulate verapamil delivery systems.
2. Controlled-release coatings and pellet structures.
3. Once-daily bedtime dosing.
4. Treatment of hypertension using an evening-administered extended-release formulation.
5. Manufacturing methods for drug-layered or polymer-coated beads.

The original protection is mature. The practical generic strategy is therefore generally based on an ANDA showing rather than a license to reproduce the brand’s excipient formula.

A current Orange Book review should confirm whether any patents remain listed for the applicable reference listed drug and strength. The FDA Orange Book is the controlling source for listed patents, expiration dates, and exclusivity status.[3]

When does Verelan PM lose exclusivity?

The primary exclusivity period for an older verapamil extended-release product has expired. Any current generic barrier is more likely to arise from:

• Product-specific bioequivalence requirements
• Manufacturing complexity
• Limited market size
• ANDA approval timing
• Commercial discontinuation of the reference product
• Supply-chain economics
• Any remaining listed patents or regulatory exclusivity shown in the current Orange Book

Verelan PM should not be analyzed as a biologic product. Biosimilar pathways do not apply. Competition proceeds through small-molecule generic pathways, primarily under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

What is the FDA regulatory status of Verelan PM?

Verelan PM is a small-molecule prescription drug product historically approved under an NDA. Generic versions require ANDA approval and must demonstrate pharmaceutical equivalence and bioequivalence to the FDA-designated reference listed drug.[4]

The regulatory analysis should distinguish three products:

Product type	Regulatory route	Key requirement
Brand Verelan PM	NDA	Safety, efficacy, quality, and clinical evidence
Generic equivalent	ANDA	Pharmaceutical equivalence and bioequivalence
Reformulated or novel extended-release product	NDA or 505(b)(2)	Bridging studies plus formulation-specific data

For a generic capsule, the target product profile normally includes the same active ingredient, strength, dosage form, route, and extended-release performance. FDA may require fed and fasting studies, multiple-dose studies, or other comparative testing depending on the product-specific guidance and reference product status.

How should a company design a Verelan PM excipient strategy?

A practical excipient program should separate regulatory equivalence from commercial differentiation.

Strategy 1: Develop a direct generic equivalent

The lowest-risk route is a multiparticulate capsule with:

• Verapamil hydrochloride drug-layered onto inert spheres
• A water-insoluble release-controlling film
• A capsule shell compatible with the reference product
• Three strengths or a validated proportional-strength strategy
• Dissolution testing across multiple pH conditions
• Comparative bioequivalence against the reference product

This approach minimizes clinical risk but requires strong process control. The formulation should be designed around dissolution robustness rather than a single target profile.

Strategy 2: Use a non-infringing polymer system

A company can evaluate alternative release-controlling materials, including:

• Ethylcellulose dispersions
• Ammonio methacrylate copolymers
• Hypromellose-based matrices
• Combination polymer films
• pH-independent diffusion coatings
• Multiparticulate systems using different core materials

The formulation must maintain verapamil release across gastrointestinal pH conditions. Verapamil is highly soluble, so excessive reliance on a single low-permeability coating may produce dose dumping or unstable release if coating defects occur.

Strategy 3: Develop a differentiated product

Potential product concepts include:

• Lower-cost generic capsules
• Strength combinations designed to reduce pill burden
• Sprinkle-capable multiparticulate capsules, if supported by stability and bioequivalence data
• Alternative capsule shells for vegetarian or religious-market requirements
• Improved moisture protection
• Tamper-evident packaging
• Unit-dose packaging for adherence programs
• A 505(b)(2) product with a revised dosing schedule or delivery profile

A sprinkle product requires separate evaluation because opening the capsule can alter dose uniformity, pellet recovery, food interaction, and patient handling.

What manufacturing and intellectual-property barriers affect generic entry?

The principal manufacturing barrier is reproducibility. Multiparticulate products have more critical process parameters than conventional immediate-release tablets.

Risk area	Commercial consequence
Pellet size variation	Broadens dissolution variability
Uneven drug layering	Creates dose-content variation
Coating defects	Raises risk of rapid release
Polymer batch variation	Changes release rate
Agglomeration	Reduces capsule fill uniformity
Moisture uptake	Alters coating permeability and stability
Capsule-shell incompatibility	Affects appearance, brittleness, and dissolution
Scale-up from laboratory coating	Can invalidate development batches

The formulation should use a design-of-experiments program covering coating weight, polymer concentration, spray rate, inlet temperature, and curing conditions. In-process controls should include pellet size distribution, assay uniformity, friability, moisture, coating weight gain, and dissolution.

Excipient sourcing also creates a commercial risk. A generic manufacturer should qualify at least two suppliers for the principal polymer and capsule shell where feasible. Changes in polymer viscosity or dispersion solids can trigger post-approval comparability work.

Which companies are challenging Verelan PM?

Competition should be assessed through FDA Orange Book and Drugs@FDA records rather than historical marketing databases alone. Generic availability can change because manufacturers withdraw products, transfer ANDAs, or stop commercializing selected strengths.

The relevant competitive set includes:

• Manufacturers of verapamil hydrochloride extended-release capsules
• Manufacturers of extended-release verapamil tablets
• Suppliers of immediate-release verapamil
• Private-label generic distributors
• Contract manufacturers with multiparticulate coating capacity

A company may hold an approved ANDA without maintaining active commercial supply. For investment or licensing analysis, the critical distinction is between regulatory approval and current market availability.

What Paragraph IV risks exist for Verelan PM?

A Paragraph IV certification is relevant only if the current Orange Book lists an unexpired patent for the reference product. A generic applicant can certify that a listed patent is invalid, unenforceable, or will not be infringed. The brand holder may then file patent litigation within the statutory period, potentially triggering a 30-month stay of approval under the Hatch-Waxman framework.[5]

For an older verapamil extended-release product, the more likely risks are commercial rather than patent-driven:

• A first-filer advantage may be unavailable or irrelevant if no qualifying listed patent remains.
• A weak market may support only one or two suppliers.
• Low annual volume may not justify multiparticulate manufacturing investment.
• A product withdrawal can complicate reference-product sourcing and bioequivalence planning.

A current litigation search should cover federal district courts, the Federal Circuit, FDA patent certifications, and any settlement agreements involving the applicable ANDA numbers.

What commercial opportunities exist for Verelan PM excipients?

The excipient opportunity is strongest for suppliers and contract manufacturers that can support modified-release development rather than simply sell commodity ingredients.

Excipient supplier opportunities

Polymer suppliers can compete through:

• Consistent viscosity and particle-size specifications
• Ready-to-use aqueous dispersions
• Technical support for fluid-bed coating
• Lower residual-solvent profiles
• Documentation for nitrosamine, elemental impurity, and microbiological controls
• Dual sourcing and global regulatory support

CDMO opportunities

A CDMO with Wurster coating, drug layering, and capsule-filling capacity can offer:

• Development batches for ANDA sponsors
• Scale-up and process validation
• Comparative dissolution development
• Stability programs
• Multiple-strength manufacturing
• Packaging and serialization
• Tech transfer to regional generic companies

Geographic opportunities

Demand is likely to be strongest where extended-release verapamil remains reimbursed and where local generic competition is limited. The United States offers the clearest Hatch-Waxman pathway. Europe and other markets require separate assessments of national authorization, reference-product status, and formulation-specific data requirements.

The same formulation may not transfer directly across jurisdictions because reference products, labeling, strength availability, and bioequivalence expectations can differ.

How does Verelan PM compare with competing verapamil products?

Product type	Release profile	Formulation complexity	Generic opportunity
Immediate-release verapamil tablet	Rapid, divided dosing	Low	Mature and price-competitive
Conventional extended-release tablet	Prolonged release	Moderate	Depends on reference product
Verelan PM capsule	Multiparticulate, once daily	High	Attractive only with coating capability
Novel abuse-deterrent or specialty delivery	Customized	Very high	Requires differentiated clinical or commercial value

Verelan PM has a formulation advantage for flexible multiparticulate engineering, but its market opportunity is constrained by the availability of other verapamil formulations and low brand differentiation.

Key Takeaways

• Verelan PM is a verapamil hydrochloride multiparticulate extended-release capsule.
• The core excipient strategy uses inert cores, drug layering, polymeric film coating, capsule materials, and process aids.
• Release performance depends heavily on polymer grade, coating weight, pellet size, and process conditions.
• Biosimilar risk does not apply; competition is through small-molecule generic pathways.
• The primary regulatory route is an ANDA, unless a company pursues a materially different product under an NDA or 505(b)(2) application.
• The main commercial barriers are multiparticulate manufacturing, dissolution control, scale-up, and limited market size.
• The best opportunities are generic supply, private-label manufacturing, excipient systems, and CDMO services.
• Current patent, exclusivity, ANDA, and litigation conclusions should be based on the applicable FDA Orange Book and Drugs@FDA records.

FAQs

Can Verelan PM be reformulated with different excipients?

Yes. A generic product does not generally need to duplicate the brand’s inactive ingredients. It must meet applicable pharmaceutical-equivalence, bioequivalence, quality, labeling, and performance requirements.

Is Verelan PM a biologic or biosimilar product?

No. Verelan PM contains the chemically synthesized small molecule verapamil hydrochloride. Biosimilar legislation does not govern its competition.

Are Verelan PM pellets suitable for sprinkling on food?

Only if the specific product labeling permits capsule opening and sprinkle administration. A generic manufacturer would need to support the instruction with product-specific dose-uniformity, stability, dissolution, and bioequivalence data.

What is the most important excipient for Verelan PM release?

The release-controlling polymer system is the most important functional excipient component. Its performance depends on polymer grade, coating thickness, pore structure, and manufacturing conditions.

Is Verelan PM an attractive generic development target?

It can be attractive for a company with existing multiparticulate coating capacity and access to verapamil extended-release reference product. The opportunity is weaker for a new entrant that must build coating infrastructure for a limited-volume market.

References

1. U.S. Food and Drug Administration. (n.d.). Verelan PM prescribing information.
2. National Library of Medicine. (n.d.). DailyMed: Verelan PM, verapamil hydrochloride extended-release capsules.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2023). ANDA submissions: Content and format.
5. U.S. Food and Drug Administration. (2017). Approved drug products with therapeutic equivalence evaluations, 37th edition.