CLINICAL TRIALS PROFILE FOR PEGINTRON

All Clinical Trials for PEGINTRON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018031 ↗	Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Clinical Trial Conditions for PEGINTRON

Condition Name

Condition Name for PEGINTRON
Intervention	Trials
Hepatitis C, Chronic	49
Hepatitis C	28
Chronic Hepatitis C	8

Condition MeSH

Condition MeSH for PEGINTRON
Intervention	Trials
Hepatitis	82
Hepatitis C	81
Hepatitis A	76

Clinical Trial Locations for PEGINTRON

Trials by Country

Trials by Country for PEGINTRON
Location	Trials
United States	89
Japan	7
Netherlands	6
Germany	5
France	5

Trials by US State

Trials by US State for PEGINTRON
Location	Trials
Maryland	8
Pennsylvania	7
New York	6
Georgia	5
California	5

Clinical Trial Progress for PEGINTRON

Clinical Trial Phase

Clinical Trial Phase for PEGINTRON
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	29
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PEGINTRON
Clinical Trial Phase	Trials
Completed	79
Terminated	10
Unknown status	8

Clinical Trial Sponsors for PEGINTRON

Sponsor Name

Sponsor Name for PEGINTRON
Sponsor	Trials
Merck Sharp & Dohme Corp.	64
Schering-Plough	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for PEGINTRON
Sponsor	Trials
Industry	89
Other	60
NIH	8

Last updated: May 20, 2026

PegIntron (peginterferon alfa-2b): clinical trials update, market analysis, and exclusivity-driven generic and biosimilar outlook

PegIntron (peginterferon alfa-2b) is an older immunotherapy in chronic hepatitis indications. Its US commercial profile has been structurally eroded by direct-acting antivirals (DAAs) for hepatitis C and by shifting treatment standards across hepatitis B. Patent and regulatory exclusivity have largely run out, so the key business question is not near-term “new launches,” but inventory of remaining branded usage, residue demand, and the extent of any lingering formulation or method-of-use protections in specific jurisdictions.

---

What is PegIntron (peginterferon alfa-2b) and what indications drive remaining demand?

PegIntron is pegylated interferon alfa-2b. Pegylation extends half-life and supports weekly dosing in older regimens. In practice, commercial use has narrowed because hepatitis C is predominantly treated with DAAs that offer higher cure rates and fewer adverse events.

What clinical role does PegIntron still have in hepatitis?

• Hepatitis C (HCV): Former standard of care in combination regimens, now mostly displaced by DAAs.
• Hepatitis B (HBV): Interferon-based therapies remain a minority approach versus nucleos(t)ide analogs, depending on patient selection and region. PegIntron can still be relevant in certain clinical pathways, but market demand is limited versus newer HBV strategies.

What are the main peginterferon competitors that affect PegIntron’s market?

• Pegylated interferon alfa products historically competed within interferon classes.
• DAAs for HCV have been the dominant competitive displacement force.
• In HBV, long-term oral antivirals have reduced reliance on interferon.

---

What is the latest clinical-trials status for PegIntron?

No credible “latest active trials” summary can be produced from the information provided. Clinical-trial updates require a current registry pull (ClinicalTrials.gov / EU CTR / WHO ICTRP), including status, dates, and protocol identifiers, which is not available here.

---

When does PegIntron lose exclusivity in the US (Orange Book status)?

A complete exclusivity assessment needs the FDA Orange Book listing(s), including:

• Listed drug application (NDA) numbers
• Patent numbers tied to each OTC/strength/form
• Expiration dates for each patent
• Exclusivity codes (e.g., 5-year, 3-year) and relevant data-protection expirations

That Orange Book dataset is not provided, so a complete, accurate “when exclusivity ends” timeline cannot be produced.

---

Which patents protect PegIntron in key jurisdictions (US, EP, JP, CN), and what is the expiration schedule?

A patent-coverage build requires:

• Patent family identification for peginterferon alfa-2b under specific brand or assignee estates
• Claim-scope mapping (composition vs formulation vs method-of-use)
• Jurisdictional priority and grant/term computation

No patent dataset is supplied, so an expiration schedule by jurisdiction cannot be generated without risking inaccuracies.

---

How strong is the PegIntron patent estate for formulations, dosing regimens, and method-of-use?

A strength assessment requires the issued-claim corpus and litigation or opposition history (where applicable), plus FDA listed-patent linkage if the strategy turns on Orange Book enforcement.

No such patent-lifecycle information is available in the prompt, so an “estate strength” profile would be speculative.

---

What Paragraph IV challenges are on record for PegIntron, and what settlements affect generic entry?

Paragraph IV requires:

• ANDA filing records
• FDA acceptance letters
• Court dockets and complaint filings
• Settlement dates and terms (if publicly disclosed)

No ANDA or litigation dataset is provided, so no accurate challenge/settlement landscape can be stated.

---

What is the market size trajectory for PegIntron, and how does it trend versus DAAs for HCV?

A quantified market projection needs:

• Historical US/EU sales series by year
• Country-level SKU rationalization (strength, pack size)
• Pricing changes post-generic entry
• Treatment-standards shift data (guideline timelines)

None of these data inputs are provided. Without them, any numeric projection would be fabricated.

---

How does PegIntron pricing evolve, and what drives gross-to-net changes?

Peginterferon pricing behavior depends on:

• Branded-to-generic transition timing per market
• PBM contracting and rebate structures
• Patient mix shifts (interferon-use narrowing)
• Coverage policies and utilization controls

No pricing or rebate history is included, so the drivers cannot be mapped to observed numbers.

---

What generic entry risks exist for PegIntron, and which manufacturing/IP barriers block near-term competition?

Generic entry risk analysis needs:

• Available ANDA approvals or tentative approvals for the same strengths and dosage forms
• Bioequivalence requirements and whether peginterferon is considered “complex” for formulation generic feasibility
• Any process patents on manufacturing, freeze-drying, or vial filling

No Orange Book or ANDA approval history is provided, so the generic-entry risk cannot be evaluated.

---

How does PegIntron compare with other peginterferons (brand and generic) on efficacy, tolerability, and dosing?

A defensible comparison needs:

• Head-to-head or meta-analytic efficacy data by indication
• Tolerability profiles and discontinuation rates
• Dosing schedules across countries and label changes
• Current positioning in guidelines

Those comparative datasets are not included, so a factual comparison cannot be produced.

---

Where is PegIntron still used commercially, and what is the geographic split in sales?

Geographic split requires sales-by-country data and procurement signals (e.g., tenders, government supply programs). No regional sales distribution data is included.

---

What FDA regulatory milestones matter for PegIntron (label changes, safety communications, REMS or postmarketing actions)?

A regulatory milestone table requires:

• FDA label history
• Safety communications (e.g., boxed warning updates, monitoring requirements)
• Postmarketing requirements
• Any REMS status

No FDA action history is provided.

---

Key Takeaways

• PegIntron demand is structurally constrained by the displacement of hepatitis C by DAAs and by selective HBV use patterns.
• A current clinical-trials update, Orange Book exclusivity timeline, patent-expiration schedule, Paragraph IV/generic entry landscape, and numeric market projections cannot be produced from the information given.
• Any business decision that depends on dates, patent counts, or litigation posture requires registry and Orange Book/patent docket inputs that are not present in the prompt.

---

FAQs

1. Is PegIntron still guideline-recommended for hepatitis C in 2026?
2. What dosage strengths and formulations of PegIntron have remaining listings in major markets?
3. Are there any active PegIntron bioequivalence or generic approval actions in the FDA pipeline?
4. Do method-of-use patents for interferon-based regimens affect generic labeling for PegIntron?
5. What safety updates or monitoring requirements most influence payer coverage for peginterferon therapies?

---

References (APA)

1. (No sources were provided in the prompt, and no external registry data was included.)