NITROLINGUAL PUMPSPRAY Drug Patent Profile

Which patents cover Nitrolingual Pumpspray, and what generic alternatives are available?

Nitrolingual Pumpspray is a drug marketed by Pohl Boskamp and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in seven countries.

The generic ingredient in NITROLINGUAL PUMPSPRAY is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitrolingual Pumpspray

A generic version of NITROLINGUAL PUMPSPRAY was approved as nitroglycerin by AM REGENT on May 24^th, 1988.

Summary for NITROLINGUAL PUMPSPRAY

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,254
Drug Prices:	Drug price information for NITROLINGUAL PUMPSPRAY
DailyMed Link:	NITROLINGUAL PUMPSPRAY at DailyMed

See drug prices for NITROLINGUAL PUMPSPRAY

See drug sales revenues for NITROLINGUAL PUMPSPRAY

Pharmacology for NITROLINGUAL PUMPSPRAY

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for NITROLINGUAL PUMPSPRAY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NITROLINGUAL PUMPSPRAY	Sublingual Spray	nitroglycerin	400 mcg/spray, 4.9 g and 12 g bottles	018705	1	2012-04-17

US Patents and Regulatory Information for NITROLINGUAL PUMPSPRAY

NITROLINGUAL PUMPSPRAY is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	7,872,049		Y

Expired US Patents for NITROLINGUAL PUMPSPRAY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	5,186,925

International Patents for NITROLINGUAL PUMPSPRAY

See the table below for patents covering NITROLINGUAL PUMPSPRAY around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	125703
Canada	2037487	VAPORISATEUR DE NITROGLYCERINE (NITROGLYCERIN PUMP SPRAY)
Germany	4007705
Germany	59106106
Denmark	0448961
European Patent Office	0448961	Aérosol de nitroglycérine. (Nitroglycerine pumpspray.)

Last updated: June 21, 2026

NITROLINGUAL PUMPSPRAY market dynamics and financial trajectory: sales outlook, pricing pressure, and exclusivity-driven risk

NITROLINGUAL PUMPSPRAY (nitroglycerin) is a legacy, nonprescription-free, branded nitrate product that competes in a crowded acute angina and emergency antianginal market dominated by generics and therapeutics with broader formulary penetration. The commercial trajectory is governed more by generic substitution and payer policy than by patent exclusivity. In practice, market risk comes from ongoing channel inventory dynamics, wholesale pricing compression, and the long-run shift toward cheaper generic nitroglycerin formulations and alternative rapid-onset agents.

What is NITROLINGUAL PUMPSPRAY and what sales drivers matter?

Product profile. NITROLINGUAL PUMPSPRAY is a nitroglycerin (glyceryl trinitrate) delivery system intended for acute relief of angina. Nitrates remain one of the most established antianginal classes, but commercial headroom depends on (1) brand survival in specific geographies and channels and (2) how quickly equivalent generic nitroglycerin products replace branded units.

Key market drivers that shape revenue:

• Generic substitution velocity. Nitroglycerin products are widely off-patent and typically face fast payer and pharmacy switching where therapeutically equivalent generics exist.
• Formulary position. Even with entrenched clinical use, branded nitrate products lose value when payers steer to low-cost generics.
• Channel mix. Revenue volatility often correlates with pharmacy and wholesaler purchasing cycles rather than demand elasticity in angina.
• Delivery preference. Spray devices can retain share if pharmacists and clinicians perceive them as easier to use versus tablets, but this is rarely enough to offset pricing pressure over multi-year horizons.
• Safety-related volume shifts. Headache incidence and patient adherence influence repeat purchase patterns, but are usually not enough to prevent conversion to cheaper supply once generics are dominant.

How does exclusivity (patents and market exclusivity) affect the NITROLINGUAL PUMPSPRAY financial trajectory?

Core commercial reality: nitroglycerin spray products are not structured like biologics or oncology drugs where exclusivity can materially extend brand life. For NITROLINGUAL PUMPSPRAY specifically, the commercial trajectory is typically dominated by off-patent generic competition and by whether any device, formulation, or packaging innovations remain protected in particular regions.

Because the prompt does not provide jurisdiction-specific IP status, listed patents, or FDA/EMA regulatory history for NITROLINGUAL PUMPSPRAY, the only actionable conclusion is structural: branded unit economics for legacy nitroglycerin sprays tend to compress as generic equivalents consolidate purchasing power.

Do any patents materially extend NITROLINGUAL PUMPSPRAY revenue?

For nitrates, revenue extension usually requires one of the following, any of which must be documented in the relevant jurisdiction:

• A device- or pump-specific improvement patent
• A specific formulation concentration or excipient system
• A packaging or dosing regimens patent
• A method-of-use claim that meaningfully narrows substitutability

Absent a documented patent list for NITROLINGUAL PUMPSPRAY in the prompt, revenue extension should be treated as non-dominant versus generic substitution and payer contracting.

When does NITROLINGUAL PUMPSPRAY lose exclusivity and what does that do to pricing?

For legacy nitroglycerin brands, “loss of exclusivity” typically translates into:

• Wholesale price erosion after branded supply is replaced in tenders or pharmacy contracts
• Retail reimbursement compression where pharmacy benefit managers (PBMs) and national formularies switch to least-cost alternatives
• Margin decline as branded products are forced into discounting to maintain shelf presence

Because no exclusivity timeline, listing, or jurisdictional patent terms are provided in the prompt, a dated “lose exclusivity” schedule cannot be stated without risking inaccuracy.

What generic entry risks exist for NITROLINGUAL PUMPSPRAY?

Primary generic risks are straightforward:

• Direct nitroglycerin spray generics (same route and comparable dosing)
• Therapeutic substitutability by nitroglycerin tablets/sublingual forms or other rapid-acting antianginals used under payer protocols
• Device-level substitution if the pump mechanism is not protected, generic manufacturers can often match user experience with different engineering

Commercial risk profile: Generic entry tends to produce a stepped decline in branded share rather than a gradual slide, especially in channels where purchasing is governed by formulary tier and contracting.

How likely is biosimilar risk for NITROLINGUAL PUMPSPRAY?

Nil. Nitroglycerin is a small-molecule, so “biosimilar risk” is not applicable.

What does the Orange Book status look like for NITROLINGUAL PUMPSPRAY?

The prompt does not include FDA application numbers, NDCs, or Orange Book listings. Without those, no specific Orange Book status can be provided.

Which companies dominate the nitroglycerin spray market and how does that compare with NITROLINGUAL PUMPSPRAY?

The prompt does not provide competing product identifiers (NDC, MAH, label strength) or geographic scope. Without those inputs, a company-by-company comparison would be speculative.

How does NITROLINGUAL PUMPSPRAY pricing and reimbursement typically behave in the antianginal market?

Typical pattern for off-patent legacy small-molecule antianginals:

• List price is decoupled from net price. Discounts to wholesalers and PBMs drive net revenue more than MSRP.
• Reimbursement is channel-specific. Cash pay and insurance payers behave differently, but net impact is usually negative over time as generics are preferred.
• Contracting drives turbulence. Revenue swings may reflect contract renewal timing, not changes in clinical demand.

What matters for finance:

• Net sales decline or flatlining often comes from unit share loss rather than demand destruction.
• Gross margin tends to compress after tier shifts or contracting pressure.

What litigation and settlement risks could affect NITROLINGUAL PUMPSPRAY financials?

The prompt contains no Paragraph IV filings, ANDA litigation, or settlement references. For nitroglycerin sprays, litigation is not a universal driver the way it is for high-value patented drugs, but without docket-level data for this specific product, no case count, forum, or timing can be stated.

What regulatory pathway risks exist for NITROLINGUAL PUMPSPRAY?

Without the prompt’s jurisdiction and listing identifiers, no pathway risks can be tied to NITROLINGUAL PUMPSPRAY. Generally, small-molecule spray products face routine generic competition and post-approval CMC scrutiny, but specific regulatory events cannot be asserted.

How does NITROLINGUAL PUMPSPRAY demand evolve over a 3–5 year horizon?

Demand tends to be relatively inelastic for acute angina relief. The financial trajectory is therefore typically determined by:

• Market share and net pricing
• Formulary access
• Channel inventory corrections
• Promotion intensity at the pharmacy level

For a legacy branded nitrate spray, a realistic base-case commercial pattern is:

• Units: gradual decline as generics and alternative formulations gain preference.
• Net sales: decline faster than units if the brand is pressured into price concessions.
• EBITDA: margin deterioration unless cost structure and procurement offset revenue erosion.

Quantified financial trajectory: what range should investors model?

No financial numbers (revenue history, margin, segment reporting, or pricing data) are provided in the prompt. Under the constraints, no numeric forecast can be produced without fabricating figures.

Key takeaways

• NITROLINGUAL PUMPSPRAY sits in a mature, off-patent therapeutic class where generic substitution and payer contracting are the dominant drivers of revenue.
• The brand’s financial trajectory is most likely governed by net price compression and share shift, not by innovation-driven exclusivity.
• Biosimilar risk does not apply (small-molecule nitrate).
• Actionable forward-looking risk is channel and contracting pressure, which typically creates stepwise branded share loss when generics become the low-cost default.

FAQs

1. Is NITROLINGUAL PUMPSPRAY affected more by unit share loss or net price compression?
   Generally, both move against the brand; the relative impact depends on formulary tiering and contracting terms.

2. Do pharmacists switch nitrate sprays to generics quickly once available?
   Switching accelerates when products are positioned as therapeutically equivalent and financially lower cost under pharmacy benefit structures.

3. What alternative antianginal products can substitute for nitroglycerin spray use?
   Rapid-onset nitroglycerin dosage forms (tablets/sublingual), and other acute antianginal approaches used per clinician and payer protocols.

4. Does manufacturing or device complexity create barriers for generic sprays?
   Pump/device engineering can matter, but generic entry is usually feasible unless specific device/formulation claims remain protected in a given jurisdiction.

5. What is the biggest financial risk for legacy nitrate brands over the next five years?
   Net pricing deterioration tied to payer and pharmacy contracting and increased generic penetration.

References

1. No sources were provided in the prompt, and none were cited.