YUTOPAR Drug Patent Profile

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

Yutopar is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in YUTOPAR is ritodrine hydrochloride. There are five drug master file entries for this compound. Additional details are available on the ritodrine hydrochloride profile page.

Summary for YUTOPAR

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	2
DailyMed Link:	YUTOPAR at DailyMed

Recent Clinical Trials for YUTOPAR

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

Sponsor	Phase
Cairo University	Phase 4

See all YUTOPAR clinical trials

US Patents and Regulatory Information for YUTOPAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-002	Sep 27, 1984		DISCN	No	No
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for YUTOPAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-001	Approved Prior to Jan 1, 1982	3,410,944
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-002	Sep 27, 1984	3,410,944
Astrazeneca	YUTOPAR	ritodrine hydrochloride	TABLET;ORAL	018555-001	Approved Prior to Jan 1, 1982	3,410,944

International Patents for YUTOPAR

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

Country	Patent Number	Title	Estimated Expiration
Brazil	6567446
France	4404
Austria	264502

YUTOPAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Yutopar (Ritodrine)

Introduction

Yutopar, known generically as ritodrine, is a tocolytic drug that was widely used to treat and prevent premature labor. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its history, usage, and the factors that influenced its market presence.

Medical Uses and Mechanism of Action

Ritodrine acts as a selective β2-adrenergic receptor agonist, which helps in relaxing the uterine muscles and thereby preventing premature labor. It was available in both oral and parenteral (intravenous) forms, making it versatile for different clinical settings[1][4].

Approval and Market Entry

Ritodrine was first approved for medical use in the United States in 1984. It was marketed under various brand names, including Yutopar, Pre-Par, and Utopar. The drug was initially seen as a significant advancement in the management of preterm labor[1][4].

Market Presence and Usage

During its peak, ritodrine was a key player in the tocolytic market. It was prescribed to women at risk of preterm labor to delay birth and allow for the administration of corticosteroids to enhance fetal lung maturity. The drug's effectiveness and the critical need for tocolytics made it a staple in obstetric care[1][4].

Financial Trajectory

Initial Success

Upon its approval and market entry, ritodrine generated significant revenue due to its unique position as a treatment for premature labor. Pharmaceutical companies such as Bristol Labs Division of Bristol Myers Squibb benefited from its sales, with the drug being marketed both as tablets and injectable solutions[4].

Market Growth and Competition

The market for tocolytics saw growth in the late 1980s and early 1990s, driven by the increasing awareness and management of preterm labor. However, ritodrine faced competition from other tocolytic agents, such as magnesium sulfate and nifedipine, which also gained popularity during this period.

Decline and Withdrawal

Despite its initial success, ritodrine's market presence began to decline due to several factors. One major reason was the emergence of alternative treatments that were either more effective or had fewer side effects. Additionally, concerns about ritodrine's safety profile, including potential contraindications such as type 2 diabetes, high blood pressure, and migraines, further reduced its usage[1][4].

By 2001, ritodrine had been removed from the US market, as indicated by the FDA Orange Book. This withdrawal marked the end of its commercial availability in the United States[1].

Impact on Patients and Healthcare System

The removal of ritodrine from the market had significant implications for patients and the healthcare system. Patients who had been managed with ritodrine had to be transitioned to other tocolytic agents, which could involve adjusting treatment plans and monitoring for different side effects.

Home Infusion Therapy

Although ritodrine was not typically part of home infusion therapy (HDIT), the broader trend of HDIT, which involves administering drugs at home, was growing during the time ritodrine was on the market. This trend highlighted the shift towards more patient-centric and cost-effective healthcare solutions, even if ritodrine itself was not part of this shift[3].

Contraindications and Safety Concerns

Ritodrine had several contraindications, including type 2 diabetes, high blood pressure, and migraines. These safety concerns, along with the drug's side effect profile, contributed to its declining use and eventual withdrawal from the market[1][4].

Pharmacoeconomics

The pharmacoeconomic aspects of ritodrine involved its cost-effectiveness as a treatment for premature labor. While it was initially seen as a valuable treatment, the emergence of alternative therapies and concerns about its safety led to a reevaluation of its cost-benefit profile. The drug's removal from the market was likely influenced by these pharmacoeconomic considerations[4].

Manufacturers and Pricing

Ritodrine was manufactured by several companies, including Bristol Labs Division of Bristol Myers Squibb. Pricing data for the drug is not readily available, but its commercial success during its market presence suggests it was priced competitively within the tocolytic market[4].

Conclusion

Yutopar (ritodrine) had a significant impact on the management of premature labor during its time on the market. However, its market trajectory was marked by initial success followed by decline and eventual withdrawal due to safety concerns and the emergence of alternative treatments.

Key Takeaways

• Approval and Market Entry: Ritodrine was approved in 1984 and marketed under several brand names.
• Medical Uses: It was used to treat and prevent premature labor by acting as a selective β2-adrenergic receptor agonist.
• Market Presence: The drug was a key player in the tocolytic market but faced competition from other agents.
• Decline and Withdrawal: Ritodrine was removed from the US market by 2001 due to safety concerns and the emergence of alternative treatments.
• Impact on Patients and Healthcare: Its removal required patients to be transitioned to other treatments, highlighting the need for continuous monitoring and adaptation in healthcare.

FAQs

What was the primary use of Yutopar (ritodrine)?

Yutopar (ritodrine) was primarily used to treat and prevent premature labor by relaxing the uterine muscles.

Why was Yutopar removed from the US market?

Yutopar was removed from the US market due to safety concerns, including potential contraindications such as type 2 diabetes, high blood pressure, and migraines, as well as the emergence of alternative treatments.

What are the common contraindications of ritodrine?

Common contraindications of ritodrine include type 2 diabetes, high blood pressure, and migraines.

How did ritodrine work?

Ritodrine worked by acting as a selective β2-adrenergic receptor agonist, which helps in relaxing the uterine muscles and thereby preventing premature labor.

What were the available forms of ritodrine?

Ritodrine was available in both oral tablets and parenteral (intravenous) forms.

Who were the primary manufacturers of ritodrine?

Ritodrine was manufactured by companies such as Bristol Labs Division of Bristol Myers Squibb.

Sources

1. Wikipedia: Ritodrine
2. Adena Health System: Chg Master for Jean - Adena Health System
3. Princeton University: Home Drug Infusion Therapy Under Medicare
4. DrugBank Online: Ritodrine: Uses, Interactions, Mechanism of Action
5. BMJ Open: Investigating the effect of verapamil on preservation of beta-cell function in type 1 diabetes (Note: This source was not directly cited in the article but is listed for completeness)