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Last Updated: December 23, 2024

CAMILA Drug Patent Profile


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

Camila is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in CAMILA is norethindrone. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Camila

A generic version of CAMILA was approved as norethindrone by GLENMARK PHARMS LTD on July 22nd, 2010.

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SponsorPhase
University of California, San DiegoPhase 4

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Pharmacology for CAMILA
Drug ClassProgestin

US Patents and Regulatory Information for CAMILA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa CAMILA norethindrone TABLET;ORAL-28 076177-001 Oct 21, 2002 AB1 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

CAMILA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Camila

Introduction

Camila, a synthetic progestational hormone, is a widely used oral contraceptive medication. To understand its market dynamics and financial trajectory, it is essential to delve into various aspects including its usage, market status, competition, and financial implications.

Drug Overview

Camila is a progestin-only contraceptive pill, containing 0.35 mg of norethindrone USP. It is available in a 28-day oral regimen and is prescribed to prevent pregnancy. The drug is manufactured by several companies, including Barr, Novast Labs, Lupin, Famy Care, and Glenmark Generics[4].

Market Status

Camila is a prescription-only medication, which means it requires a doctor's prescription to be dispensed. This status can influence its market dynamics, as it may limit accessibility compared to over-the-counter (OTC) medications. However, the recent approval of the first OTC birth control pill, Opill, by the FDA in July 2023, may set a precedent for future changes in the regulatory landscape for contraceptive medications[5].

Market Competition

The contraceptive market is highly competitive, with numerous brands and types of contraceptives available. Camila competes with other progestin-only pills such as Errin and Nor-QD, which have similar formulations and uses. The competition is further intensified by the presence of combination oral contraceptives and other forms of birth control like intrauterine devices (IUDs) and implants.

Financial Implications

Revenue Generation

Camila generates revenue through prescription sales. The pricing of Camila can vary depending on the manufacturer, insurance coverage, and geographic location. However, as a prescription medication, it generally falls within the affordable range for many users, especially those with health insurance.

Cost Structure

The cost structure for Camila includes production costs, marketing expenses, and distribution fees. Since it is a well-established medication, the production costs are likely optimized, allowing for a stable profit margin for the manufacturers.

Market Trends

The demand for contraceptive medications is steady and often driven by demographic factors such as population growth and reproductive health needs. However, market trends can be influenced by regulatory changes, public health initiatives, and consumer preferences. For instance, the approval of OTC birth control pills could potentially shift some market share away from prescription-only medications like Camila.

Consumer Demand

Consumer demand for Camila is driven by its effectiveness as a contraceptive and its relatively low side effect profile compared to other hormonal contraceptives. The convenience of a once-daily oral regimen also contributes to its popularity.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Camila. As mentioned, the FDA's approval of the first OTC birth control pill could lead to increased competition and potentially alter the prescription-only status of similar medications in the future. However, for now, Camila remains a prescription-only medication, which can affect its accessibility and market reach.

Financial Performance

The financial performance of Camila is tied to the overall sales volume and pricing strategies of its manufacturers. While specific financial data for Camila is not publicly available, it is part of a larger contraceptive market that is significant in terms of revenue.

Revenue Projections

Given the stable demand for contraceptive medications, revenue projections for Camila are likely to remain steady. However, any changes in the regulatory environment or the introduction of new OTC options could impact future revenue.

Impact of Public Health Initiatives

Public health initiatives aimed at increasing access to contraceptive services can positively impact the market for Camila. For example, proposals to expand coverage of contraception under private health insurance can increase the number of women accessing prescription contraceptives like Camila[2].

Conclusion

Camila operates within a competitive and regulated market, driven by steady consumer demand and influenced by regulatory and public health initiatives. Here are the key takeaways:

  • Market Competition: Camila competes with other progestin-only and combination oral contraceptives.
  • Regulatory Environment: The prescription-only status of Camila could be influenced by future regulatory changes.
  • Financial Performance: Revenue is stable but could be affected by changes in the market and regulatory landscape.
  • Consumer Demand: Driven by effectiveness and convenience.
  • Public Health Initiatives: Can increase access and demand for prescription contraceptives.

FAQs

What is Camila used for?

Camila is used as an oral contraceptive to prevent pregnancy. It contains 0.35 mg of norethindrone USP and is taken once daily in a 28-day regimen.

Is Camila available over the counter?

No, Camila is currently available only by prescription.

How does Camila compare to other contraceptive medications?

Camila is a progestin-only pill, which distinguishes it from combination oral contraceptives. It competes with other progestin-only pills like Errin and Nor-QD.

What are the potential impacts of the FDA's approval of OTC birth control pills on Camila?

The approval of OTC birth control pills could potentially shift some market share away from prescription-only medications like Camila, although this impact is speculative at this point.

How do public health initiatives affect the market for Camila?

Public health initiatives aimed at increasing access to contraceptive services can increase the number of women accessing prescription contraceptives like Camila, thereby potentially boosting sales.

Sources

  1. Pharmacompass - Camila | Drug Information, Uses, Side Effects, Chemistry[4].
  2. PR Newswire - Federal Contraception Proposal to Expand Access and Affordable Coverage Paves a Stronger Path for Mayne Pharma's Growth in Women's Health[2].
  3. Britannica - Should Birth Control Pills Be Available Over the Counter (OTC)?[5].

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