JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy III GENERIC PRODUCT DEVELOPMENT Previous Question Paper (February-2022 - R17)
Answer any five questions
All questions carry equal marks
Main
Write about Hatch – Waxman Act and its amendments.
Answer
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act of 1984, is a landmark U.S. federal law that established the modern framework for the generic drug industry. It balanced the need for affordable generic medications with the necessity of incentivizing pharmaceutical innovation.
Key provisions of the Act include:
- Abbreviated New Drug Application (ANDA): It allowed generic manufacturers to obtain FDA approval by demonstrating bioequivalence to an existing brand-name drug, without repeating costly and time-consuming clinical trials.
- Patent Term Restoration: It allowed brand-name manufacturers to extend their patent life for up to five years to compensate for time lost during the clinical trial and regulatory approval process.
- Data Exclusivity: It granted periods of market exclusivity to brand-name drugs, during which generic versions could not be approved, regardless of patent status.
- Paragraph IV Certification: It created a mechanism for generic companies to challenge invalid or unenforceable patents, often leading to litigation. The first successful challenger is awarded 180 days of generic market exclusivity.
- Bolar Amendment: It provided a safe harbor for generic companies to conduct necessary testing and research on patented drugs before the patent expires, ensuring a generic product is ready for market immediately upon patent expiration.
Significant amendments and related legislation include:
- Medicare Prescription Drug, Improvement, and Modernization Act (2003): This act addressed the abuse of the 30-month stay provision, limiting brand-name companies to only one 30-month stay per ANDA to prevent indefinite delays of generic entry.
- Biologics Price Competition and Innovation Act (2009): Part of the Affordable Care Act, this created an abbreviated approval pathway for biosimilars, extending the principles of Hatch-Waxman to biological products.
- FDA Reauthorization Act (FDARA) of 2017: This included provisions to prioritize the review of generic drug applications for products with little or no competition, further accelerating the availability of affordable alternatives.
Discuss the generic product development in U.S.
Answer
Generic product development in the U.S. is governed by the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984), which established the modern framework for the approval of generic drugs. The process is centered on the submission of an Abbreviated New Drug Application (ANDA) to the FDA.
Key aspects of the development process include:
- Bioequivalence Studies: Unlike innovator drugs that require extensive clinical trials, generic manufacturers must demonstrate that their product is bioequivalent to the Reference Listed Drug (RLD). This involves proving that the rate and extent of absorption of the generic drug do not show a significant difference from the innovator product.
- Chemistry, Manufacturing, and Controls (CMC): Developers must provide detailed information on the drug substance, drug product, manufacturing process, and stability data to ensure the generic product meets the same quality, purity, and potency standards as the innovator.
- Labeling Requirements: The generic product labeling must be the same as the RLD, except for differences related to the manufacturer, dosage form, or strength.
- Regulatory Review: The FDA reviews the ANDA to ensure the drug is safe and effective. Upon approval, the drug is listed in the Orange Book, which identifies drug products approved on the basis of safety and effectiveness.
- Exclusivity and Incentives: The U.S. system provides incentives such as the 180-day generic drug exclusivity for the first applicant to successfully challenge a patent, encouraging early entry into the market to lower healthcare costs.
Write about Patent certifications of generic product.
Answer
Sign in to view the complete answer paper.
Explain the generic Drug product development steps.
Answer
Sign in to view the complete answer paper.
Explain about Formula optimization and process optimization of generic drug product.
Answer
Sign in to view the complete answer paper.
Write about testing of in-process samples of a generic drug product.
Answer
Sign in to view the complete answer paper.
Write about Analytical method validation planning and protocol execution of a generic product.
Answer
Sign in to view the complete answer paper.
Write about various parameters of an analytical method validation.
Answer
Sign in to view the complete answer paper.
Write about Accelerated stability studies of a generic Drug product.
Answer
Sign in to view the complete answer paper.
Explain about shelf life development of a generic drug product.
Answer
Sign in to view the complete answer paper.
Explain in-vivo tests to ensure bioequivalence of test product.
Answer
Sign in to view the complete answer paper.