Last Updated: August 8, 2026

NITROL Drug Patent Profile


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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 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 Nitrol

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

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US Patents and Regulatory Information for NITROL

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 ⤷  Start Trial ⤷  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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