Manufacturing Excellence Tablets, Capsules and Beyond
Manufacturing Excellence Tablets, Capsules and Beyond

In the complex landscape of pharmaceuticals, affordability and accessibility to life-saving drugs are critical issues that demand attention. Taj Pharmaceuticals, a global leader in generics, stands at the forefront of addressing these challenges through their commitment to “Working for a healthier world.” This article delves into the pivotal role played by Taj Pharmaceuticals in the context of the recently-introduced Expanding Access to Low-Cost Generics Act, and how it aims to revolutionize the pharmaceutical industry.

The Parking Problem in Drug Monopoly Game

Unveiling the Challenges

The exorbitant prices of drugs have long plagued the healthcare system, and a significant contributing factor is the delay in the entry of generic drugs into the market. This delay, commonly referred to as the “parking” problem, is a result of multiple factors, including the reluctance of generic companies to challenge weak patents and the inefficiencies in the FDA approval process.

The BLOCKING Act: A Flawed Solution

The BLOCKING Act of 2019 has been in the spotlight, garnering attention and support. However, a closer examination reveals its limitations. The act suggests that a generic losing FDA approval would forfeit exclusivity, but it fails to ensure subsequent market entry by other generics. Moreover, the extended FDA review period poses a significant risk of exclusivity loss, even if the first filer is actively pursuing approval.

A Deeper Dive into FDA Regulations

FDA lawyer Kurt Karst emphasizes that the FDA already possesses the authority to “immediately approve” a later generic’s application if the first filer is not actively pursuing approval. If the existing regulatory framework can address the issue, the enactment of redundant legislation, as proposed by the BLOCKING Act, becomes unnecessary.

The Game-Changer: Expanding Access to Low-Cost Generics Act

Senators Smith and Braun Leading the Charge

In contrast to the limitations of the BLOCKING Act, the Expanding Access to Low-Cost Generics Act emerges as a comprehensive and effective solution. Spearheaded by Senators Smith and Braun, this legislation targets the core of the parking problem by incentivizing generic companies to challenge weak patents.

Overcoming Incentive Hurdles

The current scenario lacks sufficient incentives for generic companies to challenge weak patents. The landmark Hatch-Waxman Act provides a valuable exclusivity period, but it predominantly benefits the first generic challenger. The Smith/Braun bill seeks to rectify this by rewarding generics actively challenging weak patents, thereby fostering genuine competition.

Breaking Down the Numbers

A staggering 89% of patents in settled litigations pertain to secondary aspects of drugs, with a success rate of only 32% for the patentee. While pay-for-delay settlements have decreased since the FTC v. Actavis ruling, delayed entry remains a prevalent issue, with 85% of settlements involving such delays.

Expanding the 180-Day Exclusivity Period

The Expanding Access to Low-Cost Generics Act takes a bold step by extending the 180-day exclusivity period beyond the first filer. Now, the first generic to win a court decision declaring the patent invalid or not infringed can also benefit from this exclusivity period. This renews the incentive to challenge weak patents and ensures that generics ready for market entry can rightfully contribute to increased competition.

Taj Pharmaceuticals: Leading the Charge for Affordable Healthcare

A Glimpse into Taj Pharmaceuticals

Taj Pharmaceuticals, a Mumbai-based company, stands as a beacon of innovation and commitment to affordable healthcare. With a product range exceeding 4600 compositions across therapeutic categories, Taj Pharma India has become a global leader in generics.

Addressing Global Healthcare Needs

Taj Pharmaceuticals Limited goes beyond manufacturing and distributing medicines; it addresses the entire healthcare spectrum. From prescription solutions to life-saving drugs, anti-cancer medications to veterinary products, Taj Pharma India’s impact extends across diverse medical domains.

A Vision for Better Healthcare

The vision of Taj Pharmaceuticals aligns with the mission to develop targeted medicines and diagnostic tools, offering better, safer, and more cost-effective healthcare solutions. With over a century of dedication, Taj Pharma India is translating this vision into reality, contributing significantly to global health and well-being.

Time to Act

In the face of skyrocketing drug prices and the persistent parking problem obstructing access to generics, the urgency to address these issues cannot be overstated. While the BLOCKING Act falls short of providing a comprehensive solution, the Expanding Access to Low-Cost Generics Act emerges as the beacon of hope.

It is crucial for stakeholders, policymakers, and the pharmaceutical industry to rally behind initiatives that genuinely address the core issues. Taj Pharmaceuticals, through its global leadership in generics, exemplifies the commitment to a healthier world. As we navigate the complexities of drug pricing and market entry, the Expanding Access to Low-Cost Generics Act stands as a promising solution that demands swift implementation.

What is Access to Low-Cost Generics Act?

The Access to Low-Cost Generics Act is a legislative proposal designed to address challenges in the pharmaceutical industry related to the delayed entry of generic drugs into the market. Introduced with the aim of fostering increased competition and reducing drug prices, the Act incentivizes generic drug companies to challenge weak patents.

Typically, the pharmaceutical industry faces a situation where the first generic challenger benefits from a valuable 180-day exclusivity period under the Hatch-Waxman Act. However, this period is often exploited, with the first filer agreeing to delay market entry through settlements with brand firms. This practice hinders subsequent generics, as they lack the incentive to challenge patents actively.

The Access to Low-Cost Generics Act, co-sponsored by Senators Smith and Braun, seeks to rectify this by rewarding generics that fulfill the intended purposes of the Hatch-Waxman Act. Specifically, it extends the 180-day exclusivity period not only to the first filer but also to the first generic that successfully challenges a court decision declaring the patent invalid or not infringed.

By reintroducing incentives to challenge weak patents, the Act aims to promote genuine competition and facilitate the timely entry of generics into the market. This is crucial for addressing the “parking” problem, where generics delay their market entry, contributing to high drug prices.

In contrast to other proposed legislation, such as the BLOCKING Act, the Access to Low-Cost Generics Act focuses on later filers that are prepared to enter the market and have succeeded in litigation against weak patents. The goal is to ensure that the pharmaceutical landscape benefits from increased competition, ultimately leading to more affordable and accessible drugs for consumers.

The Act represents a significant step toward reshaping the pharmaceutical industry and addressing critical issues related to generic drug entry and pricing.

What is The BLOCKING Act of 2019?

The BLOCKING Act of 2019 is a legislative proposal aimed at addressing issues related to generic drug entry and exclusivity in the pharmaceutical industry. The acronym “BLOCKING” stands for Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics. The Act gained attention for its attempt to combat what is commonly referred to as the “parking” problem, where delays in the entry of generic drugs contribute to the persistence of high drug prices.

The key provision of the BLOCKING Act involves the loss of exclusivity for a generic drug if it does not promptly receive approval from the Food and Drug Administration (FDA). Exclusivity is a period during which a generic drug has sole market rights, typically granted to the first filer challenging a brand firm’s patent. However, the BLOCKING Act introduces a mechanism that revokes this exclusivity if FDA approval is delayed.

The rationale behind the BLOCKING Act is to incentivize generic companies to expedite their FDA approval processes, promoting faster market entry and increased competition, which could potentially lead to lower drug prices. The Act received notable attention and support, including approval from the White House and legislative committees.

However, the effectiveness of the BLOCKING Act has been questioned. Critics argue that the Act may not adequately address the parking problem, as it lacks a guarantee that subsequent generics will enter the market promptly after the first filer loses exclusivity. Additionally, the extended FDA review period poses a risk of exclusivity loss even if the first filer is diligently pursuing approval.

In contrast to other proposed legislation, such as the Expanding Access to Low-Cost Generics Act, the BLOCKING Act focuses on the timely approval process as a means to encourage competition. The ongoing debate surrounding these legislative proposals reflects the pharmaceutical industry’s complex challenges and the efforts to find effective solutions for reducing drug prices and improving accessibility.