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Last Updated: April 23, 2025

JUNEL 1.5/30 Drug Patent Profile


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When do Junel 1.5/30 patents expire, and when can generic versions of Junel 1.5/30 launch?

Junel 1.5/30 is a drug marketed by Barr and is included in one NDA.

The generic ingredient in JUNEL 1.5/30 is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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Drug patent expirations by year for JUNEL 1.5/30
Drug Sales Revenue Trends for JUNEL 1.5/30

See drug sales revenues for JUNEL 1.5/30

Pharmacology for JUNEL 1.5/30
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for JUNEL 1.5/30

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Barr JUNEL 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 076381-001 May 30, 2003 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Junel 1.5/30

Introduction

Junel 1.5/30 is a combination oral contraceptive pill (OCP) that utilizes a blend of two hormones, progestin and estrogen, to prevent pregnancy. This medication is part of a broader market of hormonal contraceptives, which is influenced by various factors including regulatory environments, consumer preferences, and technological advancements.

Market Overview

The pharmaceutical market for hormonal contraceptives, including Junel 1.5/30, is characterized by several key trends and dynamics.

Regulatory Environment

The approval and regulation of pharmaceuticals like Junel 1.5/30 are stringent and involve multiple stages, including clinical trials and manufacturing compliance. For instance, the FDA ensures that such medications adhere to current Good Manufacturing Practices (GMPs) and address any deficiencies before approval[2].

Consumer Preferences and Health Trends

Consumers are increasingly looking for convenient, affordable, and effective healthcare solutions. Junel 1.5/30, being a combination birth control pill, fits into this demand by offering a reliable method of contraception along with other benefits such as treating acne, reducing the risk of ovarian cysts, and managing painful or heavy periods[1][5].

Technological and Pharmaceutical Trends

The pharmaceutical industry is shifting towards more personalized and preventive healthcare. While Junel 1.5/30 is not a precision medicine, the broader industry trends towards personalized treatments and early intervention could influence how such medications are marketed and prescribed in the future[3].

Financial Aspects

Pricing and Affordability

Junel 1.5/30 is relatively affordable, especially with insurance coverage. Patients can pay as little as $0 with insurance, plus a medical consultation fee, or around $25-$27 per pack without insurance. Generic equivalents further reduce the cost, making it accessible to a wider audience[1][5].

Revenue Streams

The revenue for Junel 1.5/30 comes from both insured and uninsured patients. The medication's affordability and the option for generic equivalents help in maintaining a steady customer base. Additionally, online prescription services and free delivery options enhance customer convenience, potentially increasing sales.

Cost Structure

The cost structure for Junel 1.5/30 includes manufacturing costs, regulatory compliance expenses, marketing, and distribution. The FDA's stringent regulations and the need for ongoing compliance can add to the operational costs. However, the economies of scale achieved through large production volumes help in managing these costs[2].

Competitive Landscape

Generic Equivalents

Junel 1.5/30 faces competition from its generic equivalents such as Blisovi 1.5/30, Larin 1.5/30, Aurovela 1.5/30, and Hailey 1.5/30. These generics have the same active ingredients and dosage, making them attractive alternatives for cost-conscious consumers[5].

Other Birth Control Options

The market for birth control is diverse, with options ranging from progestin-only pills (POPs), intrauterine devices (IUDs), implants, and condoms. Junel 1.5/30 must compete with these alternatives, particularly among women who may have specific health conditions or preferences that make other options more suitable[5].

Side Effects and Safety Profile

Common Side Effects

While generally safe, Junel 1.5/30 can cause minor side effects such as breast tenderness, headaches, nausea, and slightly elevated blood pressure or blood sugar levels. Positive side effects include reduced acne and fewer mood swings[5].

Serious Side Effects

Although rare, serious side effects such as heart disease, blood clotting, and vision problems can occur. These risks are a critical consideration in the financial trajectory, as they can impact patient adherence and the overall market reputation of the medication[5].

Interactions and Contraindications

Drug Interactions

Junel 1.5/30 can interact with various drugs, including HIV medications, anti-seizure drugs, antibiotics, and herbal supplements like St. John’s wort. These interactions can reduce the effectiveness of the medication and are a key factor in patient counseling and medical consultations[5].

Contraindications

Women with high blood pressure or those taking blood pressure medications are advised against using Junel 1.5/30. Instead, they are recommended alternative birth control methods such as progestin-only pills, IUDs, or implants[5].

Market Projections and Future Outlook

Industry Trends

The pharmaceutical industry is moving towards prevention, personalization, and prediction. While Junel 1.5/30 is not at the forefront of these trends, the industry's shift could influence how birth control medications are developed and marketed in the future. For instance, there might be a greater focus on personalized contraceptive options based on genetic and behavioral factors[3].

Economic Implications

The development and pricing of pharmaceuticals, including Junel 1.5/30, are influenced by economic factors such as the cost of research and development, market demand, and regulatory environments. The ability to target small patient populations with precision medicines can lead to higher prices and profits, although this is not directly applicable to Junel 1.5/30[4].

Key Takeaways

  • Affordability: Junel 1.5/30 is relatively affordable, especially with insurance coverage and generic equivalents.
  • Regulatory Compliance: Strict FDA regulations ensure the safety and efficacy of the medication.
  • Competitive Landscape: The medication competes with other birth control options and generic equivalents.
  • Side Effects and Safety: While generally safe, Junel 1.5/30 can have minor and rare serious side effects.
  • Interactions and Contraindications: The medication interacts with various drugs and is contraindicated for women with high blood pressure.
  • Future Outlook: The pharmaceutical industry's trends towards prevention, personalization, and prediction may influence future developments in birth control medications.

FAQs

Q: What are the active ingredients in Junel 1.5/30?

A: Junel 1.5/30 contains a combination of progestin and estrogen.

Q: How does Junel 1.5/30 prevent pregnancy?

A: It prevents ovulation, thickens cervical mucus to block sperm, and alters the uterine lining to prevent egg attachment[1].

Q: What are the common side effects of Junel 1.5/30?

A: Common side effects include breast tenderness, headaches, nausea, and slightly elevated blood pressure or blood sugar levels[5].

Q: Can women with high blood pressure take Junel 1.5/30?

A: No, women with high blood pressure or those taking blood pressure medications are advised against using Junel 1.5/30[5].

Q: Are there any generic equivalents for Junel 1.5/30?

A: Yes, generic equivalents include Blisovi 1.5/30, Larin 1.5/30, Aurovela 1.5/30, and Hailey 1.5/30[5].

Sources

  1. Nurx: Junel Fe 1.5/30 (Loestrin Fe) Birth Control Online.
  2. FDA: 022501Orig1s000 - accessdata.fda.gov.
  3. PwC: Pharma industry trends: PwC.
  4. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  5. Pandia Health: Buy Junel 1.5/30 Birth Control Pills Online With Free Delivery.

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