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Last Updated: December 22, 2024

GANTANOL-DS Drug Patent Profile


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Which patents cover Gantanol-ds, and when can generic versions of Gantanol-ds launch?

Gantanol-ds is a drug marketed by Roche and is included in one NDA.

The generic ingredient in GANTANOL-DS is sulfamethoxazole. There are twenty-seven drug master file entries for this compound. Additional details are available on the sulfamethoxazole profile page.

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Summary for GANTANOL-DS
Drug patent expirations by year for GANTANOL-DS

US Patents and Regulatory Information for GANTANOL-DS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche GANTANOL-DS sulfamethoxazole TABLET;ORAL 012715-003 Approved Prior to Jan 1, 1982 DISCN 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

GANTANOL-DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GANTANOL-DS

Introduction to GANTANOL-DS

GANTANOL-DS, containing the active ingredient sulfamethoxazole, is an antibacterial sulfonamide used to treat various infections such as urinary tract infections, meningitis, ear infections, and eye infections. To understand its market dynamics and financial trajectory, we need to delve into several key aspects.

Clinical Use and Pharmacology

GANTANOL-DS is clinically used for its antibacterial properties. Sulfamethoxazole is rapidly absorbed after oral administration and exists in the blood in various forms, with the free form being the therapeutically active component[4].

Market Position of Antibacterials

The market for antibacterial drugs is significant but faces challenges such as antibiotic resistance and the rise of generic alternatives. Unlike biologics, which are seeing significant growth and competition from biosimilars, small molecule drugs like GANTANOL-DS are more susceptible to generic competition[1].

Generic Competition

About 40% of the small molecule market sales are accessible to generics, with generic efficiency remaining high at around 97%. This indicates that once a small molecule drug like GANTANOL-DS loses its patent protection, it is likely to face substantial competition from generic versions, which can significantly reduce its market share and revenue[1].

Pricing Dynamics

The pricing of GANTANOL-DS, like other generic or off-patent drugs, is generally lower compared to branded or innovative drugs. The list price and net price after discounts and rebates are crucial factors. However, for generic drugs, the pricing is often driven by competition and regulatory pressures, leading to lower profit margins[3].

Market Size and Growth

The antibacterial market, while substantial, is not growing at the same rate as other segments like biologics or newer therapeutic areas such as obesity treatments. The market for antibacterials is relatively stable but can be affected by factors like antibiotic stewardship programs and the emergence of resistant bacterial strains.

Financial Trajectory

Given the generic nature of GANTANOL-DS, its financial trajectory is likely to be influenced by the following factors:

Revenue Decline Post-Patent Expiry

Once the patent for GANTANOL-DS expires, the drug is likely to face significant competition from generic versions, leading to a decline in revenue.

Pricing Pressure

Generic competition typically leads to pricing pressure, reducing the net price the drug can command in the market.

Volume Sales

While the price per unit may decrease, volume sales can remain stable or even increase if the drug is widely prescribed and used. However, this is often offset by the lower pricing.

Cost-Effectiveness

GANTANOL-DS, being a generic drug, is generally cost-effective compared to newer, branded antibiotics. This can help maintain its market share to some extent.

Comparative Market Analysis

To put the financial trajectory of GANTANOL-DS into perspective, let's compare it with other drug markets:

  • Biologics Market: Biologics represent a growing share of the pharmaceutical market, with 42% of the total medicines market in 2018, up from 30% in 2014. This segment is less relevant to GANTANOL-DS but highlights the shift towards more innovative and high-value therapies[1].
  • Obesity Treatments: The market for obesity treatments, such as GLP-1s, is estimated to be a multi-billion dollar opportunity, with potential sales ranging from $100 billion to $150 billion annually in the U.S. alone. This contrasts sharply with the more stable but less growth-oriented antibacterial market[3].

Industry Expert Insights

Industry experts often highlight the challenges faced by generic drugs in maintaining revenue in the face of intense competition. For example, the high generic efficiency in the small molecule market means that once a drug goes off-patent, it quickly loses market share to generic alternatives[1].

Illustrative Statistics

  • By year-end 2019, about 40% of the small molecule market sales were accessible to generics, with generic efficiency at 97%[1].
  • The top 10 biologics, which are in a different market segment, each have cumulative sales of more than $40 billion since launch, indicating the high value but different dynamics of biologic drugs[1].

Impact of Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of drugs like GANTANOL-DS. Regulatory changes, such as those related to antibiotic use and resistance, can impact prescribing patterns and market demand.

Consumer and Prescriber Behavior

Consumer and prescriber behavior also influence the market dynamics. For instance, the increasing awareness of antibiotic resistance can lead to more judicious use of antibacterial drugs, affecting sales volumes.

Key Takeaways

  • Generic Competition: GANTANOL-DS faces significant competition from generic versions, leading to potential revenue decline.
  • Pricing Pressure: The drug is subject to pricing pressure due to generic competition.
  • Stable Volume Sales: Despite lower prices, volume sales can remain stable due to widespread use.
  • Cost-Effectiveness: The drug's cost-effectiveness helps maintain market share.
  • Regulatory and Consumer Factors: Regulatory changes and consumer/prescriber behavior can impact market dynamics.

FAQs

Q: What is GANTANOL-DS used for?

A: GANTANOL-DS is used to treat various infections such as urinary tract infections, meningitis, ear infections, and eye infections.

Q: How does generic competition affect GANTANOL-DS?

A: Generic competition significantly reduces the market share and revenue of GANTANOL-DS once it loses patent protection.

Q: What is the impact of pricing dynamics on GANTANOL-DS?

A: The pricing of GANTANOL-DS is driven by competition and regulatory pressures, leading to lower profit margins.

Q: How does the antibacterial market compare to other pharmaceutical markets?

A: The antibacterial market is relatively stable but less growth-oriented compared to markets like biologics or obesity treatments.

Q: What role does the regulatory environment play in the financial trajectory of GANTANOL-DS?

A: The regulatory environment, including policies on antibiotic use and resistance, can significantly impact the market demand and sales of GANTANOL-DS.

Cited Sources

  1. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC
  2. The Far Out Story of Vortex I - Nestucca Spit Press (Not relevant to the topic)
  3. A Multi-Billion-Dollar Drug Market - Baron Funds
  4. Gantanol (Sulfamethoxazole): Side Effects, Uses, Dosage - RxList

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