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Last Updated: December 22, 2024

LIBRAX Drug Patent Profile


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Summary for LIBRAX
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US Patents and Regulatory Information for LIBRAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch LIBRAX chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 012750-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  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

LIBRAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Librax

Introduction to Librax

Librax, a combination of chlordiazepoxide hydrochloride and clidinium bromide, is a medication used to treat stomach ulcers, irritable bowel syndrome, and inflammation of the colon. It belongs to the anticholinergics/antispasmodics drug class and is known for its dual action as a benzodiazepine and an anticholinergic/spasmolytic[5].

Market Size and Sales

The Librax market, including both the brand and generic versions, has shown significant revenue. According to IQVIA Health data, the U.S. sales for Librax and its generic equivalents totaled approximately $105.9 million for the twelve months ending in July 2021[1][4].

Generic Market Entry

Dr. Reddy's Laboratories recently launched a generic version of Librax in the U.S. market. This generic version, Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg, is approved by the U.S. Food and Drug Administration (USFDA) and is available in bottle count sizes of 100 capsules. This entry into the market is expected to increase competition and potentially reduce prices for consumers[1][4].

Pricing and Cost

The cost of Librax can be substantial. For cash-paying customers, a supply of 100 Librax capsules (5 mg-2.5 mg) can cost around $5,216. However, generic versions are significantly cheaper, with prices starting from around $81.05 for 20 capsules[2].

Patient Assistance and Discounts

To make the medication more affordable, various patient assistance programs and discount cards are available. For example, the Drugs.com Discount Card can save patients up to 80% or more off the cost of prescription medicines, including Librax and its generic versions[2].

Therapeutic Uses and Demand

Librax is used to treat several gastrointestinal conditions, including stomach ulcers, irritable bowel syndrome, and enterocolitis. The demand for this medication is driven by the prevalence of these conditions and the need for effective treatments. The therapeutic benefits of Librax, combined with its availability in both brand and generic forms, contribute to its steady market demand[5].

Competition and Market Dynamics

The entry of generic versions into the market introduces competition that can affect the pricing and market share of the brand name Librax. Generic drugs often capture a significant portion of the market due to their lower prices, which can lead to a reduction in sales for the brand name product. However, the brand name may retain some market share due to brand loyalty and the perception of higher quality[1][4].

Financial Impact on Pharmaceutical Companies

For pharmaceutical companies like Dr. Reddy's Laboratories, the launch of a generic version of Librax can be financially beneficial. Generic drugs typically have higher profit margins due to lower development and marketing costs compared to brand name drugs. The $105.9 million annual sales figure for Librax and its generics indicates a substantial market that generic manufacturers can tap into[1][4].

Risks and Challenges

Dependence and Abuse

Librax contains chlordiazepoxide hydrochloride, a benzodiazepine, which carries risks of physical dependence, abuse, and addiction. These risks can impact the long-term use and prescription rates of the drug. Healthcare providers must carefully manage the dosage and duration of treatment to mitigate these risks[5].

Regulatory Environment

Pharmaceutical companies must navigate a complex regulatory environment. The approval process for generic drugs, for instance, involves rigorous testing to ensure therapeutic equivalence to the brand name drug. Compliance with FDA regulations is crucial for maintaining market presence and avoiding legal and financial repercussions[1].

Future Outlook

The market for Librax and its generics is expected to remain stable due to the ongoing demand for treatments of gastrointestinal conditions. However, the market dynamics can shift with changes in regulatory policies, the introduction of new treatments, and fluctuations in healthcare spending.

Generic Market Growth

The generic market is likely to continue growing as more patients opt for cost-effective alternatives. Companies like Dr. Reddy's Laboratories are well-positioned to capitalize on this trend by offering high-quality generic versions of popular medications[1][4].

Brand Loyalty and Marketing

Despite the competition from generics, brand name Librax may retain some market share through effective marketing and brand loyalty strategies. Pharmaceutical companies often invest in direct-to-consumer advertising and other promotional activities to maintain their brand's visibility and appeal[3].

Key Takeaways

  • Market Size: The U.S. market for Librax and its generics generated approximately $105.9 million in sales over the twelve months ending in July 2021.
  • Generic Competition: The entry of generic versions, such as Dr. Reddy's Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, increases competition and reduces prices.
  • Pricing: Generic versions are significantly cheaper than the brand name Librax.
  • Therapeutic Uses: Librax is used to treat stomach ulcers, irritable bowel syndrome, and enterocolitis.
  • Risks and Challenges: Includes risks of physical dependence, abuse, and addiction due to its benzodiazepine component.
  • Future Outlook: The market is expected to remain stable with potential growth in the generic segment.

FAQs

Q: What is Librax used for?

A: Librax is used to treat stomach ulcers, irritable bowel syndrome, and inflammation of the colon.

Q: How much does Librax cost?

A: The cost of Librax can be around $5,216 for a supply of 100 capsules for cash-paying customers, but generic versions are significantly cheaper.

Q: Are there generic versions of Librax available?

A: Yes, generic versions of Librax, such as Dr. Reddy's Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, are available in the U.S. market.

Q: What are the risks associated with Librax?

A: Librax carries risks of physical dependence, abuse, and addiction due to its benzodiazepine component.

Q: How does the generic market affect the brand name Librax?

A: The generic market can reduce the market share and sales of the brand name Librax due to lower prices and increased competition.

Sources

  1. Dr. Reddy's Laboratories Announces Launch of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP in the US Market. Pharmacy Times.
  2. Librax Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.
  3. 2022 ANNUAL REPORT - Bausch Health Companies Inc.. Bausch Health.
  4. Dr Reddy’s launches generic stomach ulcer drug in US market. Express Pharma.
  5. Librax (Chlordiazepoxide and Clidinium): Side Effects, Uses, Dosage, Interactions, Patient Information. RxList.

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