BIDIL Drug Patent Profile

Which patents cover Bidil, and when can generic versions of Bidil launch?

Bidil is a drug marketed by Azurity and is included in one NDA.

The generic ingredient in BIDIL is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

Summary for BIDIL

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	AB	RX	Yes	Yes

International Patents for BIDIL

See the table below for patents covering BIDIL around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1212053
Canada	2383974
Canada	1308659	METHODE DE REDUCTION DE LA MORTALITE ASSOCIEE A L'INSUFFISANCE CARDIAQUE CONGESTIVE FAISANT APPEL A L'HYDRALAZINE ET AU DINITRATE D'ISOSOBIDE (METHOD OF REDUCING MORTALITY ASSOCIATED WITH CONGESTIVE HEART FAILURE USING HYDRALAZINE AND ISOSORBIDE DINITRATE)

Last updated: February 10, 2026

mmary
BIDIL (hydralazine and isosorbide dinitrate) is marketed for heart failure treatment, primarily targeting African-American populations. Its commercial potential faces challenges from generics, limited patient base, and evolving treatment guidelines. The drug’s current financial viability depends on patent protections, market access, and reimbursement policies.

Drug Overview

• Generic Name: Hydralazine and Isosorbide Dinitrate
• Brand Name: BIDIL
• Approved Indication: Treatment of symptomatic heart failure in African-American patients intolerant of ACE inhibitors or ARBs
• Approval Date: 2005 by FDA
• Market Size: Estimated heart failure population in U.S. exceeds 6 million, with African-American subset representing approximately 25-30% (roughly 1.5-1.8 million).

Patent and Market Exclusivity

• Patent protection for BIDIL expired in 2019.
• Orphan drug designation granted in 2005 offers a 7-year market exclusivity period, but this was not extended beyond the initial period.
• Accompanying regulatory protections do not extend patent life; generic versions now available.

Market Dynamics

• Market Penetration: Limited to specific patient segments; broader heart failure market predominantly uses ACE inhibitors, ARBs, beta-blockers, and newer agents.
• Reimbursement Landscape: Reimbursement hinges on formulary inclusion; in the U.S., BIDIL remains on some formularies primarily due to its niche indication.
• Generics Impact: Competition from generic hydralazine and isosorbide dinitrate reduces margins.

Financial and Investment Considerations

• Sales Trends: U.S. sales peaked shortly after 2005 approval, with estimates around $50 million annually. Recent figures suggest a decline due to generic competition and shifting guidelines.
• Revenue Drivers: Limited to the African-American heart failure population segment. Market share in this niche remains between 5-10%.
• Licensing and Partnership Opportunities: Possible for rights acquisition or licensing to expand into underserved markets or develop combination therapies.

Competitive Landscape

• Main competitors include standard heart failure therapies (e.g., sacubitril/valsartan), which are broadly indicated and have larger market penetration.
• BIDIL's niche status limits expansion opportunities.
• Emerging therapies targeting heart failure with preserved ejection fraction (HFpEF) may further curtail BIDIL’s relevance.

Regulatory Environment

• The 2005 FDA approval leveraged the drug’s efficacy in African-American patients, but recent updates to heart failure guidelines emphasize comprehensive management, diminishing reliance on race-specific therapies.
• No recent regulatory incentives or extensions beyond initial orphan designation.

Future Outlook

• Market demand is limited by the drug’s narrow indication and the availability of newer, more effective therapies.
• Patent expiration has reduced exclusivity, increasing generic competition.
• A strategic focus on niche markets, combination therapy development, or restrictive licensing might sustain marginal revenue or open new therapeutic areas.

Key Investment Risks

• Increasing competition from generics and newer drugs.
• Declining relevance due to evolving clinical guidelines.
• Regulatory and reimbursement challenges in expanding indication use.
• Limited patient population constraining sales volume.

Key Takeaways

• BIDIL has limited growth potential due to patent expiration, generic competition, and narrow indications.
• Revenue largely depends on the continued reimbursement and formulary status within a small patient niche.
• Long-term value creation is uncertain without expansion beyond current indications or development of combination therapies.
• Investors should monitor evolving heart failure guidelines and competition dynamics, especially emerging therapies for broader populations.

FAQs

1. Does BIDIL currently hold any patent protections?
   No, its patent expired in 2019, increasing the likelihood of generic competition.

2. What is the main market for BIDIL?
   The drug mainly targets African-American patients with heart failure who cannot tolerate ACE inhibitors or ARBs.

3. How has the therapeutic landscape affected BIDIL?
   Newer heart failure drugs with broader indications and better outcomes have reduced BIDIL’s market share.

4. Is there potential for geographic expansion?
   Potential exists if licensing deals target underserved markets, but regulatory approval in new regions may pose barriers.

5. What is the outlook for BIDIL’s revenue?
   Revenue is declining, and future growth prospects are limited without significant strategic repositioning or new indications.

Sources
[1] U.S. Food and Drug Administration (FDA) drug database.
[2] MarketResearch.com, Heart Failure Market Analysis, 2022.
[3] IQVIA sales and reimbursement data, 2021-2022.