Ready-to-Use Bioequivalence Study Protocols for High-Value Generics Approaching Patent Expiry (2026–2030)
Below is a curated catalogue of high-value reference listed products (RLDs) approaching patent expiry between 2026 and 2030, together with ready-to-use bioequivalence (BE) study protocols designed to support future generic development.
The bioequivalence study protocols are aligned with current regulatory guidance (FDA & EMA) and are intended to support timeline optimisation ahead of loss of exclusivity. Each product in the catalogue is selected based on patent landscape timing, commercial relevance, and practical considerations for bioequivalence study execution.
Browse the catalogue below to explore upcoming generic development opportunities.
What’s Included?
Every bioequivalence study protocol is a complete, submission-ready document
Study Design
The BE protocols provide submission-ready study designs aligned with FDA and EMA guidance detailing a complete study approach, including objectives, endpoints, washout periods, blood sampling schedules, participant confinement, dosing procedures and other important considerations customised for each molecule to ensure regulatory compliance and successful study execution. In addition, participant safety, dietary/activity restrictions and other study management measures are included to address all key aspects of the study.
Inc/Exc Criteria
The BE protocols include detailed guidelines for participant selection and safety management. Each protocol defines participant eligibility criteria. Exclusion criteria cover medical conditions, infectious disease screening, drug allergies or hypersensitivity, recent medication use, and any condition affecting study participation. The protocols include screen failure, withdrawal, continuous safety monitoring, adverse event management, and ethical compliance measures meeting FDA and EMA requirements.
Statistical Procedures
The BE protocols outline regulatory-compliant statistical approaches in accordance with FDA and EMA bioequivalence guidance. Pharmacokinetic evaluations include key parameters such as peak concentration (Cmax), area under the concentration–time curve (AUC0–t and AUC0–∞), time to peak concentration (Tmax), and elimination half-life (t½). The protocols include sample size determination to ensure adequate statistical power, along with requirements for sample handling and storage and compliance with bioanalytical method standards.
Featured Molecules
Explore our library of ready-to-use bioequivalence study protocols for generics approaching patent expiry
Brivaracetam is an anti-seizure medication, used to treat partial-onset seizures in people with Epilepsy. It works by binding to a protein in the brain that affects the release of certain chemicals called neurotransmitters, which helps calm overactive nerve signals that cause seizures.
Ivabradine Hydrochloride is a heart medication used to treat chronic heart failure and stable angina. It works by selectively slowing down the heart rate without affecting blood pressure or how strongly the heart contracts, allowing the heart to pump more efficiently.
Emtricitabine/Tenofovir is a combination antiviral medication, used to treat and prevent HIV-1 infection. It works by blocking HIV’s reverse transcriptase enzyme, preventing the virus from copying its genetic material into human cells.
Sacubitril/Valsartan is a combination heart failure medication, used to reduce the risk of hospitalization and death in people with heart failure. It works in two ways: one component increases beneficial peptides that relax blood vessels, while the other blocks hormones that strain the heart.
Lurasidone Hydrochloride is an antipsychotic medication, used to treat schizophrenia and bipolar depression. It works by balancing dopamine and serotonin levels in the brain, which helps regulate mood, behaviors, and thoughts.
Lenvatinib Mesylate is a targeted cancer therapy, used to treat advanced thyroid, kidney, liver, and endometrial cancers. It works by blocking multiple proteins that promote tumor growth and blood vessel formation, helping to slow or stop cancer spread.
Tapentadol Hydrochloride is a pain medication used to manage moderate to severe acute and chronic pain. It works through dual action, that is, binding to opioid receptors for pain relief and increasing norepinephrine levels in the brain to enhance pain control.
Fostamatinib Disodium is an immune system medication that is used to treat chronic immune thrombocytopenia (ITP) when other treatments fail. It works by blocking an enzyme in immune cells that causes antibody production and platelet destruction, helping to increase platelet counts.
Tofacitinib Citrate is an immune system medication used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and other inflammatory conditions. It works by blocking specific enzymes that trigger inflammation, reducing immune system overactivity and joint damage.
Rivaroxaban is a blood thinner medication, used to prevent and treat blood clots and reduce stroke risk in people with atrial fibrillation. It works by directly blocking a key clotting protein called factor Xa, preventing blood clot formation without affecting platelets.
Why These Protocols
Developed Using Standard BE Scientific Frameworks
Built around established BE principles — dose selection, PK endpoints, sampling windows, and analytical considerations aligned with current scientific expectations.
Written and Reviewed by BE Practitioners
Drafted by medical writers experienced in pharmacokinetics and reviewed by specialists who routinely design and assess BE studies across multiple therapeutic areas.
Includes All Fundamental Components for BE Study Design
Provides complete study design, rationale, PK plan, sample collection schedule, statistical methodology, and safety framework — ready for immediate operational use.
Why Bioequivalence Studies Are Needed?
Bioequivalence studies are required by regulatory agencies such as the FDA and EMA to support the approval of generic medicines through abbreviated regulatory pathways. Bioequivalence studies provide the scientific foundation for generic drug approval by demonstrating that test formulations achieve comparable systemic exposure to reference products. This approach addresses critical needs: ensuring therapeutic interchangeability and patient safety by controlling formulation-dependent variability, streamlining regulatory review through pharmacokinetic parameters (AUC, Cmax), and reducing development costs by 70-90%, thereby expanding access to affordable medications while maintaining rigorous quality standards aligned with FDA and EMA guidance.
How to Select Molecules: Market Factors in Generic Development
Selecting molecules for bioequivalence studies involves balancing scientific feasibility with commercial opportunity:
- Patent and exclusivity timing: Molecules with clearer patent landscapes and imminent expiration dates are typically more attractive than those with complex overlapping protections.
- Market potential: The commercial value of a molecule depends on its current sales performance, the size of the patient population it serves, and whether demand is stable or growing within its therapeutic category.
- Competitive landscape: Understanding how many other generic manufacturers are likely to enter the market helps assess profitability. Markets with fewer expected competitors generally offer better financial prospects.
- Technical feasibility: Some formulations are inherently more complex to develop than others. Simpler dosage forms with well-established bioequivalence pathways reduce development time and costs compared to specialized formulations.
- Regulatory considerations: Molecules with clear regulatory guidelines and predictable approval requirements present lower development risks than those requiring novel or complex study designs.
Our protocols support this process by providing regulatory-compliant study designs that streamline development timelines for commercially promising molecules.
How to Conduct Bioequivalence Studies
Conducting bioequivalence studies requires adherence to standardized regulatory protocols established by agencies like the FDA and EMA. These studies typically employ crossover designs in healthy volunteers to compare pharmacokinetic profiles between test and reference products.
Study Design
The standard approach uses a randomized, two-period crossover design with adequate washout periods between doses. Studies are conducted under fasting conditions as baseline, with fed-state assessments added when food effects are clinically relevant. Sample sizes are determined based on expected variability to ensure adequate statistical power for regulatory conclusions.
Products and Participants
The reference product is the approved innovator formulation from the target market, while the test product represents commercial-scale generic manufacturing. Studies generally enroll healthy adult volunteers meeting specific demographic and physiological criteria, with standardized conditions maintained throughout to minimize variability.
Pharmacokinetic Assessment
Blood sampling schedules capture complete concentration-time profiles, with key parameters measuring both the extent and rate of drug absorption. Validated bioanalytical methods quantify drug concentrations, focusing on parent compound or clinically relevant forms.
Statistical Evaluation
Bioequivalence is established when the confidence interval for the ratio of geometric means between test and reference products falls within predefined acceptance criteria. These criteria may be adjusted based on drug-specific characteristics such as variability or therapeutic index.
Our protocols incorporate these methodological principles to deliver comprehensive, submission-ready study designs aligned with current regulatory guidance for efficient bioequivalence assessment.
Home > Clinical Study Design> Bioequivalence Study Protocols> Ready-to-Use Bioequivalence Protocols for High-Value Generics