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Last Updated: December 22, 2024

KELNOR Drug Patent Profile


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

Kelnor is a drug marketed by Barr and is included in one NDA.

The generic ingredient in KELNOR is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.

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US Patents and Regulatory Information for KELNOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr KELNOR ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 076785-001 May 23, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

KELNOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KELNOR

Introduction

Kelnor, a combined oral contraceptive, is manufactured by Teva Pharmaceuticals USA, Inc. and is available in two main formulations: Kelnor 1/50 and Kelnor 1/35. This article delves into the market dynamics and financial trajectory of Kelnor, including its pricing, competition, and the broader economic factors influencing its market position.

Therapeutic Category and Indications

Kelnor is classified under the contraceptives drug category and is indicated for the prevention of pregnancy in women who elect to use oral contraceptives. It is also used for treating conditions such as abnormal uterine bleeding and endometriosis[5].

Pricing and Cost

The pricing of Kelnor varies depending on the formulation and the pharmacy. For Kelnor 1/35, the cost is around $67 for a supply of 168 tablets, although generic versions can be significantly cheaper, starting from $38.18 for 84 tablets[2].

Generic Competition

The availability of generic versions of Kelnor significantly impacts its pricing. Generic competition drives prices down, making the medication more accessible to a wider population. However, the presence of generic alternatives also reduces the revenue generated by the branded product[2].

Market Competition

Kelnor operates in a competitive market with numerous other oral contraceptives available. The market is characterized by both brand-brand competition and generic competition. Once a patent expires, generic entry typically reduces prices and market share for the branded product[3].

Brand Equivalents

Kelnor has brand equivalents such as Demulen, which further increases competition in the market. This competition can lead to pricing pressures and reduced market share for Kelnor[4].

Contraindications and Risk Factors

Kelnor is contraindicated in females with certain conditions, including thrombophlebitis, thromboembolic disorders, and current or past breast cancer. These contraindications can limit its market by excluding certain patient populations[1][5].

Impact on Pricing and Sales

The presence of contraindications and risk factors can affect the pricing and sales of Kelnor. Patients with these conditions may opt for alternative treatments, reducing the demand for Kelnor. Additionally, the need for careful patient selection and monitoring can increase the overall cost of treatment, potentially impacting the financial trajectory of the drug.

Economic Factors Influencing Market Dynamics

Several economic factors influence the market dynamics of Kelnor:

Research and Development Costs

The development of pharmaceutical products, including oral contraceptives like Kelnor, involves significant research and development costs. These costs are factored into the pricing of the drug to ensure profitability for the manufacturer[3].

Patent Protection and Generic Entry

Patent protection allows pharmaceutical companies to recoup their investment in research and development by maintaining higher prices during the patent period. Once the patent expires, generic competition typically enters the market, driving prices down and reducing the revenue for the branded product[3].

Government Policies and Incentives

Government policies and incentives play a crucial role in the pharmaceutical market. Policies that support generic competition and regulate drug pricing can significantly impact the financial trajectory of branded drugs like Kelnor[3].

Patient Assistance Programs

While there are no specific patient assistance programs (PAPs) available for Kelnor, patients can benefit from discount cards and other cost-saving initiatives. These programs can help make the medication more affordable, thereby influencing its market dynamics[2].

Financial Trajectory

The financial trajectory of Kelnor is influenced by several factors:

Revenue Generation

The revenue generated by Kelnor is dependent on its market share, pricing, and the volume of sales. With the availability of generic versions and brand equivalents, the revenue from Kelnor is likely to be impacted by increased competition.

Cost Structure

The cost structure includes the costs of production, marketing, and distribution. These costs are factored into the pricing of the drug and can affect its profitability.

Future Outlook

As the pharmaceutical market continues to evolve, the financial trajectory of Kelnor will be shaped by factors such as changes in government policies, advancements in technology, and shifts in consumer preferences. The increasing focus on precision medicines and the development of new therapeutic alternatives may also influence the market position of Kelnor[3].

Key Takeaways

  • Pricing and Competition: Kelnor faces significant competition from generic versions and brand equivalents, which affects its pricing and market share.
  • Contraindications and Risk Factors: The presence of contraindications limits the patient population for Kelnor, impacting its sales and revenue.
  • Economic Factors: Research and development costs, patent protection, and government policies are crucial in determining the financial trajectory of Kelnor.
  • Patient Assistance Programs: While specific PAPs are not available for Kelnor, discount cards and other initiatives can make the medication more affordable.

FAQs

What are the main indications for Kelnor?

Kelnor is primarily indicated for the prevention of pregnancy in women who elect to use oral contraceptives. It is also used for treating conditions such as abnormal uterine bleeding and endometriosis[5].

How does generic competition affect Kelnor's pricing?

Generic competition significantly reduces the pricing of Kelnor, making it more affordable but also reducing the revenue generated by the branded product[2].

What are the contraindications for Kelnor?

Kelnor is contraindicated in females with conditions such as thrombophlebitis, thromboembolic disorders, and current or past breast cancer[1][5].

How do government policies influence the market dynamics of Kelnor?

Government policies that support generic competition and regulate drug pricing can significantly impact the financial trajectory of Kelnor by affecting its pricing and market share[3].

Are there any patient assistance programs available for Kelnor?

There are no specific patient assistance programs available for Kelnor, but patients can benefit from discount cards and other cost-saving initiatives[2].

Sources

  1. DailyMed: KELNOR 1/50 - ethynodiol diacetate and ethinyl estradiol.
  2. Drugs.com: Kelnor 1/35 Prices, Coupons, Copay Cards & Patient Assistance.
  3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. Teva USA: KelnorĀ® 1/50 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP).
  5. DailyMed: Kelnor 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets).

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