OFORTA Drug Patent Profile

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

Oforta is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in OFORTA is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oforta

A generic version of OFORTA was approved as fludarabine phosphate by HIKMA on August 28^th, 2003.

Summary for OFORTA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	19
Patent Applications:	1,552
DailyMed Link:	OFORTA at DailyMed

Recent Clinical Trials for OFORTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
California Institute for Regenerative Medicine (CIRM)	Phase 1
Hideho Okada, MD, PhD	Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1

See all OFORTA clinical trials

US Patents and Regulatory Information for OFORTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008		DISCN	No	No

Expired US Patents for OFORTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008	7,148,207
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008	7,547,776

International Patents for OFORTA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2248624
Japan	2009040797	METHOD FOR PRODUCTION OF FLUDARABINE-PHOSPHATE LITHIUM, SODIUM, POTASSIUM, CALCIUM AND MAGNESIUM SALTS, PURIFICATION METHOD FOR PRODUCING FLUDARABINE PHOSPHATE AND FLUDARABINE PHOSPHATE HAVING PURITY OF AT LEAST 99.5%
South Korea	20050085937
Jordan	2363	تركيبه نقيه من الفلودار تعطى عن طريق الفم وينطلق منها المركب الفعال بشكل فوري (ORAL FLUDARA PURE FORMULATION WITH IMMEDIATE RELEASE OF THE ACTIVE COMPOUND)
European Patent Office	1455760	FORMULATION POUR ADMINISTRATION PAR VOIE ORALE, A LIBERATION RAPIDE DU PRINCIPE ACTIF, CONTENANT DU FLUDARA EXTRA-PUR (ULTRAPURE ORAL FLUDARA FORMULATION WITH A FAST RELEASING ACTIVE SUBSTANCE)

OFORTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Orphan and Specialty Drugs: The Case of Oforta

Introduction

Orphan drugs, including those like Oforta, are designed to treat rare diseases that affect a small percentage of the population. Despite their niche market, these drugs have significant financial and market implications. This article will delve into the market dynamics and financial trajectory of orphan drugs, using Oforta as a case study.

What are Orphan Drugs?

Orphan drugs are medications developed to treat rare diseases, defined as conditions affecting fewer than 200,000 people in the United States. These drugs often receive special designations and incentives from regulatory bodies like the FDA to encourage their development[2].

Oforta: An Example of an Orphan Drug

Oforta, also known as oral fludarabine, is an example of an orphan drug that was approved for specific indications but faced challenges in the market. Initially approved for certain hematological malignancies, Oforta was later voluntarily withdrawn from the market due to dwindling sales, although injectable fludarabine remained available for previously approved indications[4].

Market Dynamics of Orphan Drugs

Regulatory Incentives

Orphan drugs benefit from significant regulatory incentives, including a 50% tax credit on research and development (R&D) and access to federal grants. These incentives can substantially reduce the financial burden on companies developing these drugs[2].

Market Exclusivity

One of the most lucrative aspects of orphan drugs is the seven-year market exclusivity granted by the FDA. This exclusivity period can be extended by securing additional orphan designations for the same drug, a strategy employed by companies like AbbVie with Humira[2].

Financial Rewards

Companies often see a significant increase in stock prices upon receiving orphan drug designation. For instance, shares in publicly traded companies can rise by as much as 30% following such announcements. The 50% R&D tax credit also provides substantial financial benefits, as seen with BioMarin, which received $32.6 million in tax credits in 2012[2].

Financial Trajectory of Orphan Drugs

Development Costs and Funding

Developing orphan drugs is costly, and companies often rely on frequent capital raises to fund ongoing operations and clinical trials. This is evident in the case of small-cap biotech companies like Bio-Path Holdings, which recently announced a $4.0 million private placement to support its operations[5].

Revenue and Sales

Despite the small patient population, orphan drugs can generate significant revenue. For example, Humira, which has multiple orphan designations, generates billions of dollars in annual sales, with a portion of this revenue attributed to its orphan uses[2].

Medicaid and Public Spending

Orphan drugs, especially those approved via accelerated pathways, can account for a disproportionate share of public healthcare expenditures. For instance, drugs approved through accelerated approval pathways represent less than 0.4% of prescriptions but up to 9% of Medicaid drug spending[4].

Case Study: Oforta's Market and Financial Journey

Approval and Initial Success

Oforta was initially approved for specific hematological malignancies, benefiting from the regulatory incentives and market exclusivity associated with orphan drugs.

Challenges and Withdrawal

Despite these advantages, Oforta faced significant challenges in the market, leading to its voluntary withdrawal due to dwindling sales. This highlights the risks and uncertainties associated with the development and commercialization of orphan drugs[4].

Financial Implications

The withdrawal of Oforta from the market had financial implications for the company, including potential losses and the need to redirect resources. This underscores the importance of continuous market assessment and strategic planning in the orphan drug sector.

Key Trends in the Orphan Drug Market

Increasing Demand and Expansion

The demand for orphan drugs is increasing, driven by advances in research and development, as well as growing healthcare expenditure. The Latin American biosimilars market, for example, is expected to grow significantly, reflecting broader trends in the biologics market[3].

Creative Strategies for Market Extension

Companies are employing creative strategies to extend the market life of their drugs. This includes seeking multiple orphan designations and approvals, as seen with Humira, to maximize market exclusivity periods[2].

Regulatory and Policy Considerations

There are ongoing discussions about the need for policy interventions to manage the costs associated with orphan drugs. Proposals include increasing Medicaid rebates for drugs approved via accelerated pathways until postapproval confirmatory trials are completed[4].

Conclusion

The market dynamics and financial trajectory of orphan drugs like Oforta are complex and influenced by a variety of factors, including regulatory incentives, market exclusivity, and public healthcare expenditures. While these drugs offer significant financial rewards, they also come with substantial risks and challenges.

Key Takeaways

• Regulatory Incentives: Orphan drugs benefit from significant regulatory incentives, including tax credits and market exclusivity.
• Financial Rewards: Companies can see substantial financial benefits, including increased stock prices and tax credits.
• Market Challenges: Despite incentives, orphan drugs can face market challenges, as seen with Oforta's withdrawal.
• Public Spending: Orphan drugs can account for a disproportionate share of public healthcare expenditures.
• Creative Strategies: Companies use creative strategies to extend market life and maximize exclusivity periods.

FAQs

Q: What are the key regulatory incentives for orphan drugs? A: Key incentives include a 50% tax credit on R&D and seven-year market exclusivity.

Q: How do companies benefit financially from orphan drug designations? A: Companies often see increased stock prices and receive substantial tax credits.

Q: What happened to Oforta in the market? A: Oforta was voluntarily withdrawn from the market due to dwindling sales.

Q: How do orphan drugs impact public healthcare expenditures? A: Orphan drugs can account for a significant portion of public healthcare spending, particularly in Medicaid programs.

Q: What strategies do companies use to extend the market life of orphan drugs? A: Companies seek multiple orphan designations and approvals to maximize market exclusivity periods.

Sources

1. International Narcotics Control Board. Extent of licit trade and latest trends in trafficking in precursors.
2. KFF Health News. Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies.
3. Cambridge University Press. The Pharmaceutical Market for Biological Products in Latin America.
4. JAMA Health Forum. The Perils of Increasing Medicaid Rebates for Drugs With Accelerated Approval.
5. Stock Titan. Bio-Path Holdings Announces $4.0 Million Private Placement Priced at $0.87 per Share.