BIDIL Drug Patent Profile

When do Bidil patents expire, 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
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
Drug Prices:	Drug price information for BIDIL
What excipients (inactive ingredients) are in BIDIL?	BIDIL excipients list
DailyMed Link:	BIDIL at DailyMed

See drug prices for BIDIL

Pharmacology for BIDIL

Drug Class	Arteriolar Vasodilator Nitrate Vasodilator
Physiological Effect	Arteriolar Vasodilation Vasodilation

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

Expired US Patents for BIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005

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	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)
World Intellectual Property Organization (WIPO)	0117528
Canada	2383974
Australia	7365900

BIDIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of BiDil

Introduction to BiDil

BiDil, a combination drug consisting of hydralazine hydrochloride and isosorbide dinitrate, was approved by the FDA in 2005 as the first race-based medication, specifically for the treatment of heart failure in self-identified black patients. This approval was a landmark event, but it also sparked intense debate and scrutiny.

Development and Initial Approval

BiDil was initially patented by cardiologists Jay Cohn and Peter Carson in 1989 for treating congestive heart failure. However, the FDA rejected the new drug application in 1997 due to insufficient clinical trial data. The turning point came when NitroMed, the company holding the intellectual property rights, re-examined the clinical trial data along racial lines and conducted the African American Heart Failure Trial (A-HeFT). This trial, which enrolled 1,050 self-identified African American patients, showed a 43% decrease in mortality and a 39% reduction in the risk of first hospitalization against placebo, leading to FDA approval in 2005[1][2][4].

Market Expectations and Initial Sales

The approval of BiDil was met with significant market expectations. Wall Street analysts predicted annual sales of up to $1 billion by 2010, given the estimated market of 750,000 black Americans with heart disease. However, the actual sales fell far short of these projections. According to NitroMed's 10K reports, sales from BiDil were $12.1 million in 2006, $15.3 million in 2007, and $14.9 million in 2008[1].

Financial Performance and Challenges

Despite the initial hype, BiDil's financial performance was disappointing. The drug failed to achieve commercial success, and NitroMed faced significant financial challenges. The company's stock prices fluctuated dramatically, ranging from a low of $0.15 to a high of $14.90 per share between January 2006 and March 2009. The unwillingness of third-party payers to provide reimbursement and a reduction in sales force and promotional efforts further exacerbated the financial woes[1][2].

Change in Ownership and Marketing Strategies

In April 2009, NitroMed was acquired by Deerfield Management for $36 million, and the company delisted from NASDAQ. Deerfield Capital later sold the rights to BiDil to Arbor Pharmaceuticals in late 2011. Arbor Pharmaceuticals attempted to revitalize BiDil's market presence by launching a consumer-focused marketing campaign, including a partnership with former basketball player Shaquille O’Neal as the spokesperson in 2019. This move was aimed at targeting African American patients directly, rather than just healthcare providers[2].

Skepticism and Criticism

The development and marketing of BiDil were not without criticism. Many physicians and geneticists were skeptical about the race-based indication, arguing that it reinforced outdated racial categories and ignored other significant factors such as social, economic, and environmental influences on health. The trial's design and the exclusion of a broad patient population were also points of contention[2][3].

Economic Incentives and Stakeholder Interests

The development of BiDil was heavily influenced by economic incentives and stakeholder interests. The pharmaceutical industry's role in shaping the research and marketing of BiDil was criticized for prioritizing profit over medical knowledge. The need for funding and the potential for financial gain significantly impacted the design and trajectory of the research[2][4].

Impact on Healthcare and Pharmaceutical Industry

BiDil's story highlights the complex interplay between science, economics, and social politics in the pharmaceutical industry. While it represented a step towards personalized medicine, it also raised questions about the use of racial categories in medical research and the ethical implications of targeting specific racial groups. The drug's commercial failure serves as a cautionary tale about the challenges of translating scientific breakthroughs into market success[1][2][3].

Current Status and Future Prospects

As of the latest updates, BiDil remains on the market, albeit with minimal active marketing. The partnership with Shaquille O’Neal and the shift towards consumer-focused marketing are attempts to revive the drug's market presence. However, the broader debate about race-based medicine and the need for evidence-based expansion of drug labels to include other racial groups continues[2].

Key Takeaways

• Market Expectations vs. Reality: BiDil's sales significantly underperformed initial market expectations.
• Financial Challenges: The drug's commercial failure led to financial struggles for NitroMed and changes in ownership.
• Criticism and Skepticism: The race-based indication of BiDil was criticized for reinforcing outdated racial categories and ignoring other health factors.
• Economic Incentives: The development of BiDil was heavily influenced by economic incentives and stakeholder interests.
• Impact on Healthcare: BiDil's story highlights the complexities of personalized medicine and the ethical considerations of targeting specific racial groups.

FAQs

Q: What is BiDil, and how was it approved? A: BiDil is a combination drug of hydralazine hydrochloride and isosorbide dinitrate, approved by the FDA in 2005 specifically for treating heart failure in self-identified black patients after the A-HeFT trial showed significant mortality and hospitalization reductions.

Q: Why did BiDil fail to achieve commercial success? A: BiDil's commercial failure was due to several factors, including poor sales, unwillingness of third-party payers to provide reimbursement, and a reduction in sales force and promotional efforts.

Q: How did the ownership of BiDil change over time? A: NitroMed, the initial owner, was acquired by Deerfield Management in 2009, and later the rights to BiDil were sold to Arbor Pharmaceuticals in 2011.

Q: What were the criticisms surrounding BiDil? A: Critics argued that BiDil reinforced outdated racial categories, ignored social and economic health factors, and was driven more by economic incentives than medical necessity.

Q: What is the current marketing strategy for BiDil? A: Arbor Pharmaceuticals has shifted towards a consumer-focused marketing campaign, including a partnership with Shaquille O’Neal to target African American patients directly.

Sources

1. The Lancet: "The short life of a race drug" - January 14, 2012.
2. Diggit Magazine: "BiDil and race-based medicine: perspectives and stakeholders" - March 22, 2021.
3. Health Equity: "Cardiologists' Perspectives on Race-Based Drug Labels and Prescribing" - May 22, 2019.
4. USC Gould School of Law: "From Disparity to Difference: How Race-Specific Medicines May Reinforce Racial Categories in Health Care" - 2005.