List of Excipients in Branded Drug NITROGLYCERIN

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Rouses Point Pharm	NITROGLYCERIN	nitroglycerin	43478-410	BUTANE
Rouses Point Pharm	NITROGLYCERIN	nitroglycerin	43478-410	CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE
Rouses Point Pharm	NITROGLYCERIN	nitroglycerin	43478-410	MENTHOL
Rouses Point Pharm	NITROGLYCERIN	nitroglycerin	43478-410	PEPPERMINT OIL
HF Acquisition Co LLC DBA Health First	NITROGLYCERIN	nitroglycerin	51662-1244	ALCOHOL

Generic Drugs Containing NITROGLYCERIN

Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	nitroglycerin	0378-9102	TITANIUM DIOXIDE
American Regent Inc	nitroglycerin	0517-4810	ALCOHOL
American Regent Inc	nitroglycerin	0517-4810	PROPYLENE GLYCOL
American Regent Inc	nitroglycerin	0517-4810	WATER
Cosette Pharmaceuticals Inc	nitroglycerin	0713-0564	LANOLIN

What are the Most Frequently-Used Excipients in NITROGLYCERIN?

# Of NDCs	Excipient
3	ALCOHOL
47	CALCIUM STEARATE
1	CELLULOSE, MICROCRYSTALLINE
7	CROSCARMELLOSE SODIUM
4	GLYCERYL BEHENATE/EICOSADIOATE

Last updated: August 14, 2026

ecutive summary: Nitroglycerin is a mature, multisource drug with limited opportunity for conventional active-ingredient patenting. The strongest commercial opportunities are excipient-enabled: improving chemical stability, dose uniformity, mucosal delivery, transdermal flux, container compatibility, and preservative-free parenteral presentation. Product differentiation is most attractive in sublingual tablets, metered sprays, topical rectal ointments, transdermal systems, and ready-to-use intravenous presentations. Generic competition is established, while biosimilar risk is irrelevant because nitroglycerin is a small-molecule drug.

Nitroglycerin Excipient Strategy, Formulation Patents, and Commercial Opportunities

What formulations are protected by nitroglycerin excipient strategy?

Nitroglycerin is formulated across five principal delivery systems:

Dosage form	Typical product	Primary excipient or platform priorities	Commercial position
Sublingual tablet	Nitrostat and generics	Rapid disintegration, low-dose uniformity, moisture control, taste and mouthfeel	Mature generic market
Lingual or sublingual spray	Nitrolingual and comparable products	Ethanol or cosolvent system, valve metering, spray plume, container closure	Differentiated delivery opportunity
Transdermal patch	Nitro-Dur and generics	Adhesive matrix, rate control, skin adhesion, backing-layer protection	Established but technically demanding
Topical rectal ointment	Rectiv 0.4%	Petrolatum or semisolid base, nitroglycerin distribution, dose measurement	Narrow specialty market
Intravenous solution	Tridil and generic nitroglycerin injection	Solubilization, adsorption control, tubing compatibility, dilution stability	Hospital and acute-care market

Nitroglycerin is highly potent, volatile, sensitive to formulation and packaging conditions, and susceptible to loss through adsorption or evaporation. The excipient system therefore affects product performance more directly than in many conventional oral solid drugs.

The commercial value lies in reproducible delivery at very low doses. A formulation that improves stability or dose accuracy can support regulatory differentiation even when the active ingredient is no longer patent-protected.

How does nitroglycerin chemistry affect excipient selection?

Nitroglycerin, also called glyceryl trinitrate, is an organic nitrate ester with limited aqueous compatibility and meaningful volatility. Key formulation risks include:

• Migration into plastics, tubing, elastomers, and adhesive components.
• Adsorption to infusion sets and containers.
• Degradation under heat, light, or unsuitable storage conditions.
• Dose variability from poor content uniformity.
• Skin irritation or inconsistent absorption in transdermal systems.
• Incomplete release from semisolid bases.
• Rapid loss of delivered dose after opening or improper storage.

Excipient selection must be evaluated together with primary packaging. A chemically compatible excipient can still produce a commercially weak product if the stopper, pouch, pump, tubing, or adhesive absorbs nitroglycerin.

For development purposes, the formulation should be treated as a drug-excipient-container system rather than as an active ingredient blended with conventional pharmaceutical excipients.

Which excipients are used in nitroglycerin sublingual tablets?

Nitrostat labeling identifies a conventional rapidly disintegrating tablet system containing lactose, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, and related processing excipients, depending on the marketed strength and presentation (Pfizer, 2023).

The functional roles are:

Excipient function	Candidate materials	Formulation objective
Diluent	Lactose, microcrystalline cellulose	Supports tablet weight and content uniformity
Binder	Povidone	Maintains mechanical strength at low drug loading
Superdisintegrant	Croscarmellose sodium or crospovidone	Accelerates sublingual breakup
Lubricant	Magnesium stearate	Supports compression and ejection
Glidant	Colloidal silicon dioxide	Improves powder flow
Moisture control	Low-moisture grades, protective packaging	Limits degradation and physical instability

What is the main excipient challenge in sublingual tablets?

The central challenge is balancing tablet strength with rapid disintegration. Excessive compression, over-lubrication, or hydrophobic excipient loading can slow tablet breakup and reduce the intended sublingual delivery profile.

A commercially useful development program would focus on:

1. Narrowing assay variability at the microgram-to-low-milligram dose level.
2. Reducing sensitivity to humidity.
3. Improving disintegration without excessive friability.
4. Controlling mouthfeel and residual tablet particles.
5. Developing unit-dose packaging that limits moisture ingress.

Direct-compression platforms are attractive because they reduce processing steps. Wet granulation can improve content uniformity but may increase exposure to water and process heat. A dry-granulated or engineered-particle approach can create differentiation if it improves uniformity without slowing release.

What excipients and technologies are used in nitroglycerin sprays?

Sublingual and lingual sprays use a liquid formulation combined with a metered pump and container-closure system. Nitrolingual products use an alcohol-containing formulation, with inactive ingredients and device specifications established in the approved labeling (Pohl-Boskamp, 2023).

The key formulation variables are:

• Solvent or cosolvent composition.
• Nitroglycerin concentration.
• Pump metering volume.
• Spray plume geometry.
• Valve and actuator compatibility.
• Evaporation rate.
• Priming and repriming behavior.
• Container orientation and residual volume.
• Ethanol exposure and patient tolerability.

Where are the commercial opportunities in spray formulations?

Sprays offer more defensible product differentiation than standard sublingual tablets because the delivery device and formulation operate as an integrated system. Potential opportunities include:

• More consistent dose delivery after storage.
• Lower residual volume in the container.
• Improved performance at different temperatures.
• Reduced ethanol content where clinically and technically feasible.
• Better plume deposition under the tongue.
• Unit-dose or tamper-evident packaging.
• Combination of dose counter, lockout, or adherence monitoring.
• Improved compatibility with travel and emergency-use packaging.

A new spray would likely require substantial device and human-factors work. The commercial case is strongest where the product can improve usability, reduce dosing errors, or address supply limitations rather than merely replicate an existing spray.

What excipients are used in nitroglycerin transdermal patches?

Transdermal nitroglycerin systems generally use a drug-in-adhesive or reservoir-based architecture. Typical components can include pressure-sensitive adhesives, polymers, plasticizers, release liners, backing films, and permeation-control materials. Exact compositions vary by manufacturer and may be proprietary.

The principal excipient and material classes include:

Component	Possible materials	Technical role
Adhesive	Acrylic or rubber-based pressure-sensitive adhesive	Maintains skin contact and can control release
Polymer matrix	Polyisobutylene or related polymers	Holds nitroglycerin and regulates diffusion
Plasticizer	Mineral oil or compatible plasticizer	Adjusts flexibility and drug mobility
Backing layer	Polyester or multilayer film	Protects the formulation from evaporation and contamination
Release liner	Silicone-coated film	Protects the adhesive before use
Permeation modifier	Selected fatty materials or solvents	Adjusts skin flux, subject to safety and stability limits

How can excipient strategy improve transdermal nitroglycerin?

The strongest technical targets are:

• Consistent delivery across skin types.
• Reduced cold-flow and edge lifting.
• Better adhesion during sweating or movement.
• Lower residual drug after removal.
• Reduced skin irritation.
• Improved storage stability.
• Lower manufacturing variability in drug loading.
• More reliable delivery after prolonged wear.

Transdermal products also require attention to dose dumping, crystallization, adhesive aging, and nitroglycerin migration into the backing or liner. A patch with superior adhesion but declining drug release over its labeled wear period is not commercially competitive.

A new patch could pursue a 505(b)(2) strategy if it presents a meaningful change in delivery system, dose, wear time, or clinical use. The regulatory pathway would depend on the proposed product and the extent of reliance on an established reference.

What excipients are used in nitroglycerin ointments?

Rectiv 0.4% is a topical rectal nitroglycerin ointment. The labeled inactive base includes white petrolatum and lanolin (U.S. Food and Drug Administration, 2011).

The ointment base must provide:

• Uniform nitroglycerin distribution.
• Consistent dose withdrawal from the tube.
• Controlled spreading on the application site.
• Adequate drug release from the semisolid base.
• Stability during storage and repeated opening.
• Acceptable skin and mucosal tolerability.

What are the formulation opportunities for nitroglycerin ointment?

Potential improvements include:

• A metered-dose applicator that reduces dosing variability.
• A lower-allergen or lanolin-free base.
• Better dose retention on the application site.
• Reduced mess and leakage.
• Unit-dose packaging.
• Improved content uniformity over the product shelf life.
• A cream, gel, or emulsion system with comparable clinical performance.
• Packaging that minimizes patient contact with nitroglycerin.

A metered applicator may create more defensible device and method-of-use claims than a reformulated ointment alone. The product would need to demonstrate reliable dose delivery through the full labeled use period.

How should excipients be selected for intravenous nitroglycerin?

Intravenous nitroglycerin requires special control of container and administration-set interactions. Commercial injections have used dextrose-containing solutions and cosolvent systems, including propylene glycol and alcohol in legacy presentations, according to product labeling (U.S. Food and Drug Administration, 2022a).

Key development issues include:

• Adsorption to polyvinyl chloride tubing.
• Compatibility with non-PVC administration sets.
• Dilution stability.
• Low extractables and leachables.
• Sterility assurance.
• Container closure integrity.
• Dose recovery during the first minutes of infusion.
• Compatibility with hospital pumps and connectors.

What is the opportunity for ready-to-use nitroglycerin injection?

A ready-to-use, preservative-free, non-PVC-compatible presentation could reduce pharmacy preparation and administration errors. Commercial formats could include:

• Prefilled syringes.
• Small-volume bags.
• Standardized diluted infusion bags.
• Dual-chamber or point-of-care systems.
• Barcode-enabled hospital packaging.

The business case depends on hospital purchasing, shortage resilience, nursing workflow, and compatibility data. A formulation that eliminates compounding steps can compete even in a generic market if it reduces total administration cost.

What patents protect nitroglycerin products?

Nitroglycerin as an active ingredient is an old, public-domain compound. The principal patent opportunities are therefore formulation, device, packaging, manufacturing, and method-of-use claims.

Claim category	Commercial relevance	Patent strength
Nitroglycerin composition of matter	Minimal for modern products	Effectively unavailable
Sublingual tablet composition	Moderate if tied to measurable performance	Usually narrow
Spray formulation and metering device	Moderate to strong when integrated	Potentially useful
Transdermal adhesive matrix	Moderate	Depends on non-obvious material combination
Ointment base and applicator	Moderate	Stronger when dose metering is demonstrated
IV container and tubing compatibility	Moderate	Useful for product and device protection
Manufacturing process	Moderate	Valuable if it solves uniformity or stability problems
Method of use	Limited to specific clinical use	Vulnerable to generic carve-outs

The most commercially relevant patent estate would combine formulation claims with device, packaging, and process claims. A single excipient substitution generally provides weak protection unless it produces an unexpected stability, delivery, or clinical result.

When does nitroglycerin lose exclusivity?

Nitroglycerin has no meaningful new-molecule exclusivity remaining. The active ingredient has been used clinically for decades, and multiple generic dosage forms are marketed.

Exclusivity category	Current commercial relevance
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not central to standard nitroglycerin products
Pediatric exclusivity	Product-specific and not a current platform for the active ingredient
Formulation patents	Product-specific; generally the main remaining patent pathway
Method-of-use patents	Narrow and subject to labeling-based carve-outs
Device patents	Relevant to sprays, patches, and applicators
Regulatory exclusivity for a new 505(b)(2) product	Possible if statutory requirements are met

Exact Orange Book patent status is product-specific because listings differ among Nitrostat, topical ointment, spray, patch, and injectable products. FDA’s Orange Book remains the controlling source for current listed patents and regulatory exclusivity (U.S. Food and Drug Administration, 2024).

What is the Orange Book status of nitroglycerin?

Nitroglycerin products are generally multisource products with established generic competition. Orange Book analysis should be performed by reference product and dosage form rather than by active ingredient alone.

Important distinctions include:

• A sublingual tablet may have a different reference product from a spray.
• A transdermal system may require therapeutic-equivalence analysis distinct from an oral tablet.
• A topical rectal ointment may not have the same generic substitution pathway as a conventional tablet.
• An injectable product may face container, concentration, and presentation differences.
• Device components can affect approval even when the active ingredient is identical.

For commercial diligence, the relevant questions are whether an approved generic exists, whether the product is therapeutically equivalent, whether any listed patent remains enforceable, and whether a proposed product can use an ANDA, 505(b)(2), or another pathway.

Which companies are challenging nitroglycerin products?

Nitroglycerin has a broad generic supplier base across tablets, patches, ointments, sprays, and injections. Generic manufacturers and contract manufacturers have competed primarily on supply reliability, hospital contracts, manufacturing cost, and dosage-form availability.

There is no biosimilar pathway for nitroglycerin because it is a chemically defined small molecule. Competition is therefore driven by:

• ANDA approvals.
• Therapeutic-equivalence ratings.
• Device equivalence for sprays and patches.
• Manufacturing capacity.
• Hospital and wholesaler contracting.
• Product shortages.
• Packaging and supply-chain performance.

A challenger seeking premium pricing would need to offer a distinct delivery system or measurable operational benefit. A conventional tablet copy faces low barriers to substitution and limited pricing power.

What patent litigation and Paragraph IV risks affect nitroglycerin?

Paragraph IV risk is generally limited for older nitroglycerin products because the active ingredient and many conventional dosage forms have long commercial histories. Risk can re-emerge when a branded product relies on:

• A recently issued formulation patent.
• A metered spray device.
• A novel adhesive matrix.
• A specific applicator.
• A new dosage regimen.
• A newly approved 505(b)(2) product.

A generic applicant could challenge listed patents by asserting invalidity, non-infringement, or unenforceability. For method-of-use patents, a section viii statement or labeling carve-out may reduce exposure if the protected indication can be omitted from the proposed label.

Potential settlement structures would include delayed launch, license rights, supply arrangements, or agreements tied to a specific indication. Because nitroglycerin markets are mature and often low-margin, litigation economics may favor narrow product-specific settlements rather than broad patent campaigns.

How strong is the nitroglycerin patent estate?

The overall patent estate is weak for the active ingredient and conventional formulations, but it can be moderate for integrated delivery platforms.

Stronger protection

• Spray plus actuator plus metering architecture.
• Adhesive matrix with defined flux and stability properties.
• Applicator delivering a reproducible rectal dose.
• Container system that prevents adsorption or evaporation.
• Manufacturing process producing unusually tight content uniformity.
• Ready-to-use injection with documented compatibility advantages.

Weaker protection

• Routine substitution of one filler for another.
• Conventional lactose-based tablet compositions.
• Broad claims covering nitroglycerin with standard excipient classes.
• Undifferentiated topical bases.
• Method claims that merely restate established clinical use.

Patent value depends on claim scope, demonstrated performance, freedom to operate, and the ability of a competitor to design around the formulation.

What licensing deals could create value in nitroglycerin?

Licensing opportunities are more likely to involve platform technologies than the nitroglycerin molecule. Attractive assets include:

• Metered sublingual delivery devices.
• Low-dose content-uniformity technologies.
• Transdermal adhesive systems.
• Drug-compatible polymer films.
• Non-PVC infusion materials.
• Low-permeability packaging.
• Digital dose counters and adherence systems.
• Hospital-ready prefilled or premixed presentations.

A license should secure rights to formulation, device, packaging, and manufacturing know-how together. Licensing only the active ingredient or a generic excipient platform would provide limited differentiation.

What generic launch scenarios exist for nitroglycerin?

Launch scenario	Likely market effect	Strategic implication
Conventional sublingual tablet	Rapid substitution and price pressure	Compete on supply and cost
Generic topical ointment	Moderate substitution friction	Improve applicator and dose control
Generic patch	Device and adhesion barriers	Invest in equivalence and human factors
Generic spray	Higher technical complexity	Protect device and plume performance
Ready-to-use injection	Hospital procurement opportunity	Quantify workflow and error reduction
Reformulated 505(b)(2) product	Potential premium pricing	Build clinical and device differentiation

The most attractive launch strategy is usually a differentiated presentation rather than another conventional tablet. Hospital injections and patient-facing sprays offer clearer value propositions than commodity oral solids.

What FDA regulatory status applies to nitroglycerin products?

FDA-approved nitroglycerin products include sublingual tablets, topical ointments, transdermal systems, sprays, and intravenous injections. The regulatory route depends on the dosage form and the proposed level of similarity to an approved reference product.

• Conventional tablets may qualify for an ANDA.
• A product with a materially different formulation, device, route, or clinical use may require a 505(b)(2) application.
• Transdermal systems require extensive performance, adhesion, and dose-delivery characterization.
• Sprays require device and human-factors assessment.
• Injectable products require sterility, container compatibility, and administration-set studies.
• Topical products require product-specific performance and, where applicable, comparative clinical evidence.

FDA labeling and DailyMed provide the controlling composition, dosage, administration, and storage information for each marketed presentation (U.S. Food and Drug Administration, 2022b; National Library of Medicine, 2024).

What is the best commercial excipient strategy for nitroglycerin?

The strongest strategy is to select excipients around a specific business problem:

Business problem	Excipient or platform response	Potential value
Sublingual dose variability	Engineered powder blend and rapid-disintegration system	Better quality and substitution performance
Moisture sensitivity	Low-moisture excipients and high-barrier unit packaging	Longer stability and lower waste
Spray dose inconsistency	Optimized solvent, pump, and actuator	Improved dose reliability
Patch detachment	Adhesive and backing-layer redesign	Better adherence and patient acceptance
Ointment dosing errors	Metered applicator and controlled semisolid base	Differentiation and safer use
IV adsorption	Non-PVC container and administration system	More predictable delivered dose
Hospital preparation burden	Ready-to-use diluted product	Workflow and procurement advantage

The preferred commercial path is a combination product with a defensible device or packaging element, supported by formulation performance data. Excipients alone rarely create durable market exclusivity in a mature nitroglycerin market.

Key takeaways

• Nitroglycerin has no meaningful new-molecule exclusivity remaining.
• Conventional sublingual tablets are difficult to differentiate and face established generic competition.
• Spray, transdermal, ointment, and ready-to-use injectable products offer better commercial opportunities.
• The principal formulation risks are volatility, adsorption, migration, moisture sensitivity, and dose variability.
• Packaging and administration hardware are as important as excipient selection.
• The strongest patent claims cover integrated formulation-device-container systems.
• A 505(b)(2) strategy may support differentiated dosage forms, but the product must show a meaningful advantage or rely on an appropriate regulatory basis.
• Biosimilar risk does not apply.
• Premium pricing is most plausible for metered delivery, improved adherence, hospital workflow reduction, or shortage-resistant supply.

FAQs

Can nitroglycerin be reformulated as a sustained-release oral product?

Yes, but the commercial and regulatory case is difficult. Sustained-release delivery must address nitrate tolerance, dose control, and the established clinical role of rapid rescue therapy. A sustained-release product would likely require a distinct clinical rationale and could not rely solely on an excipient change.

Which nitroglycerin dosage form has the highest formulation barrier?

Transdermal patches and metered sprays generally have higher technical barriers than sublingual tablets. Their performance depends on device, material compatibility, dose delivery, and stability over the labeled use period.

Is ethanol necessary in nitroglycerin sublingual spray?

Ethanol can function as a solvent and support rapid evaporation and delivery, but the necessity of ethanol depends on the target concentration, solvent system, pump, and stability profile. Removing or reducing ethanol would require reformulation and comparative performance evidence.

Can a nitroglycerin patch obtain new patent protection?

Yes. Protection may be available for a novel adhesive matrix, multilayer structure, controlled-release profile, packaging system, or manufacturing process. The claims must satisfy novelty and non-obviousness requirements and should be supported by comparative performance data.

What is the most promising nitroglycerin product opportunity?

A metered, patient-friendly spray or a ready-to-use hospital injection has the clearest potential for differentiation. Both can address dosing reliability and workflow problems that a conventional generic tablet does not solve.

References

1. National Library of Medicine. (2024). DailyMed: Nitroglycerin product labeling. U.S. National Library of Medicine.

2. Pfizer Inc. (2023). Nitrostat (nitroglycerin) sublingual tablets prescribing information. U.S. Food and Drug Administration labeling archive.

3. Pohl-Boskamp GmbH & Co. KG. (2023). Nitrolingual Pumpspray prescribing information. U.S. Food and Drug Administration labeling archive.

4. U.S. Food and Drug Administration. (2011). Rectiv (nitroglycerin) ointment prescribing information. Drugs@FDA.

5. U.S. Food and Drug Administration. (2022a). Nitroglycerin injection prescribing information. Drugs@FDA.

6. U.S. Food and Drug Administration. (2022b). Nitro-Dur transdermal therapeutic system prescribing information. Drugs@FDA.

7. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.