NITROL Drug Patent Profile

Name: NITROL Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Nitrol, and what generic alternatives are available?

Nitrol is a drug marketed by Rorer and Pohl Boskamp and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in NITROL is nitroglycerin. There is one drug master file entry for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nitrol

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

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Summary for NITROL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	69
Patent Applications:	695
Drug Prices:	Drug price information for NITROL
DailyMed Link:	NITROL at DailyMed

Drug patent expirations by year for NITROL

US Patents and Regulatory Information for NITROL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rorer	NITROL	nitroglycerin	INJECTABLE;INJECTION	018774-001	Jan 19, 1983		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pohl Boskamp	NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705-001	Oct 31, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	7,872,049	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: June 12, 2026

NITROL (Nitroglycerin) Market Dynamics and Financial Trajectory: Revenue, Access, Competition, and Exclusivity Timeline

Executive summary: NITROL (nitroglycerin) remains a legacy, largely generics-driven cardiovascular product category where pricing power depends on formulary access, channel mix (retail vs institutional), and the small-share differentiation that survives after launch. Financial trajectory is typically characterized by early-cycle brand peaks (if any), then sustained share erosion once labeled generics and repack products establish shelf presence. For a data-backed market view, revenue and financial trajectory must be tied to the exact NDA/ANDA listing, dosage form (e.g., sublingual tablets vs topical/transdermal), and strength because NITROL is used as a proprietary trade name across multiple nitroglycerin presentations in different markets.

No actionable market and financial trajectory can be produced from the identifier “NITROL” alone.

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Summary for NITROL

NITROL (Nitroglycerin) Market Dynamics and Financial Trajectory: Revenue, Access, Competition, and Exclusivity Timeline

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