Drug Mechanism and Overview of Percocet

Oxycodone binds to mu-opioid receptors in the central nervous system, providing potent analgesic effects. Acetaminophen inhibits prostaglandin synthesis, alleviating pain signal transmission. This combination is a key treatment option prescribed for moderate to severe acute pain. The original drug is Percocet from Endo Pharmaceuticals, and Granules' product is a bioequivalent generic. It offers a pharmacological advantage by providing excellent pain relief while reducing the total dose of opioid components compared to single opioid formulations.

FDA Approval History and Production Structure

The product received ANDA number 211708 from the FDA and was finally approved on October 31, 2019. As a generic application, the review was completed quickly without convening a separate FDA Advisory Committee (AdComm). Granules India Ltd (NSE: GRANULES), a global generic manufacturing company based in India, and its U.S. subsidiary, Granules Pharmaceuticals, directly oversee the entire manufacturing and distribution process. It vertically integrates from raw material production to packaging in facilities that meet U.S. cGMP standards, minimizing supply chain instability risks.

U.S. Market Size and Demand Trends

The U.S. market for oxycodone-acetaminophen combination drugs is a large market, valued at approximately $1.8 billion (approximately 2.5 trillion Korean Won) in 2023. With annual prescription volume exceeding 7.3 million to 12.5 million, it boasts unparalleled demand in the field of post-operative pain management. Recently, due to strengthened regulations on opioid abuse, the total prescription volume has been gradually decreasing by about 5% annually. However, due to the absolute demand from pain patients, it maintains a solid volume. The moderate increase in surgical procedures due to the aging population is playing a role in preventing a sharp decline in the market.

Competitive Landscape and Differentiation Strategy

The market is competitive, with global generic companies such as Teva Pharmaceuticals (Ticker: TEVA) and Mallinckrodt Pharmaceuticals (Ticker: MNK), and the original manufacturer, Endo International (Ticker: ENDP). Granules Pharmaceuticals' entry into the market will intensify multi-party competition, leading to lower generic drug prices and reducing the financial burden on patients. In particular, Granules leverages its strength in directly manufacturing active pharmaceutical ingredients (APIs) to secure superior cost competitiveness and maximize negotiating power when listing on pharmacy benefit manager (PBM) formularies.

Strict Opioid Regulations and Risk Management

However, due to its opioid component, this product is classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA) and is subject to strict manufacturing and distribution quotas. The manufacturer must comply with Risk Evaluation and Mitigation Strategy (REMS) protocols during product distribution, making the manufacturer's compliance management capabilities a key competitive factor. Therefore, Granules continues to strengthen its quality control system and maintain supply contracts with major PBMs to respond to fluctuations in raw material supply and legal risks.