CLINICAL TRIALS PROFILE FOR LOPURIN

All Clinical Trials for LOPURIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00899431 ↗	Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)	Terminated	Celgene Corporation	Phase 2	2009-05-06	The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.
NCT00899431 ↗	Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)	Terminated	M.D. Anderson Cancer Center	Phase 2	2009-05-06	The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.
NCT01685411 ↗	Busulfan and Cyclophosphamide Followed By ALLO BMT	Terminated	Masonic Cancer Center, University of Minnesota	N/A	2013-01-01	This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.
NCT03128879 ↗	Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Recruiting	AbbVie	Phase 2	2017-06-16	This phase II trial studies how well venetoclax and ibrutinib work in treating participants with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may work better in treating participants with chronic lymphocytic leukemia/small lymphocytic lymphoma.
NCT03128879 ↗	Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2017-06-16	This phase II trial studies how well venetoclax and ibrutinib work in treating participants with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may work better in treating participants with chronic lymphocytic leukemia/small lymphocytic lymphoma.
NCT03128879 ↗	Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Recruiting	M.D. Anderson Cancer Center	Phase 2	2017-06-16	This phase II trial studies how well venetoclax and ibrutinib work in treating participants with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may work better in treating participants with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Clinical Trial Conditions for LOPURIN

Condition Name

Condition Name for LOPURIN
Intervention	Trials
Chronic Lymphocytic Leukemia	2
Acute Lymphoblastic Leukemia	1
Acute Myeloid Leukemia	1
BTK Gene Mutation	1

Condition MeSH

Condition MeSH for LOPURIN
Intervention	Trials
Leukemia	3
Leukemia, Lymphoid	3
Leukemia, Lymphocytic, Chronic, B-Cell	2
Lymphoma	1

Clinical Trial Locations for LOPURIN

Trials by Country

Trials by Country for LOPURIN
Location	Trials
United States	3

Trials by US State

Trials by US State for LOPURIN
Location	Trials
Texas	2
Minnesota	1

Clinical Trial Progress for LOPURIN

Clinical Trial Phase

Clinical Trial Phase for LOPURIN
Clinical Trial Phase	Trials
Phase 2	2
N/A	1

Clinical Trial Status

Clinical Trial Status for LOPURIN
Clinical Trial Phase	Trials
Terminated	2
Recruiting	1

Clinical Trial Sponsors for LOPURIN

Sponsor Name

Sponsor Name for LOPURIN
Sponsor	Trials
M.D. Anderson Cancer Center	2
Celgene Corporation	1
Masonic Cancer Center, University of Minnesota	1

Sponsor Type

Sponsor Type for LOPURIN
Sponsor	Trials
Other	3
Industry	2
NIH	1

LOPURIN (Allopurinol) Clinical Trials Update, Market Analysis, and Exclusivity-to-Generic Projection

Last updated: July 24, 2026

LOPURIN is an allopurinol brand. No product-specific clinical-trial or regulatory exclusivity dossier can be compiled from the input provided. A market projection and trial update for “LOPURIN” specifically cannot be produced without a defined drug strength, dosage form, applicant/marketing authorization holder, and jurisdictional regulatory identifiers.

What is LOPURIN and what active ingredient does it use? Answer: LOPURIN is a brand of allopurinol (a xanthine oxidase inhibitor used to treat hyperuricemia and gout).

Which therapeutic uses matter for market sizing?

• Gout and hyperuricemia management
• Prevention of urate nephrolithiasis in eligible patients
• Tumor lysis syndrome prophylaxis in specific settings (where allopurinol is used)

What product attributes change commercial exposure?

• Strength and dosage form (tablet vs other)
• Line extensions (generic substitution rules vary by market)
• Local formulary status and procurement pricing

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What clinical trials exist for LOPURIN (allopurinol), and what’s the latest update?

Answer: A LOPURIN-branded clinical-trials update cannot be issued from the input provided because “LOPURIN” is typically a brand name mapped to a known active ingredient (allopurinol), and clinical-trial listings must be tied to a specific sponsor, NCT/ID, and formulation.

How to interpret “clinical trials” risk for a brand like LOPURIN

• If LOPURIN is not the innovator, most trial evidence is for allopurinol itself, not for a specific brand formulation.
• Market-relevant evidence is usually pharmacokinetic bioequivalence and safety experience rather than new efficacy trials.

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Is LOPURIN FDA-approved and what is its regulatory status (Orange Book)?

Answer: A jurisdiction-specific FDA Orange Book status cannot be produced from the input provided.

What matters for exclusivity analysis

• Whether the listing is under an innovator NDA vs an ANDA
• Patent term and any pediatric exclusivity
• Method-of-use coverage (if any)
• Whether any patents are only “listed” but not enforceable against generics (depends on Orange Book structure and litigation)

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How many patents protect allopurinol brands like LOPURIN, and what are the key patent types?

Answer: A complete “how many patents protect LOPURIN” answer cannot be produced without the specific Orange Book entry and patent numbers tied to the marketing authorization for LOPURIN.

Patent estate categories that typically drive generic timelines

• Drug substance patents (xanthine oxidase inhibition scaffold or synthesis)
• Drug product/formulation patents (coatings, excipients, dissolution profile)
• Method-of-use patents (gout dosing strategies, patient subgroups, tumor lysis protocols)
• Manufacturing process patents (granulation, sterilization where relevant)

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When does LOPURIN lose exclusivity and what is the generic entry risk?

Answer: A credible exclusivity timeline cannot be established from the input provided.

Generic entry dynamics for older small-molecule brands

• For widely used molecules like allopurinol, exclusivity is usually far beyond current operational relevance, and competition is driven by ANDA economics, pricing, and supply chain rather than patent term.
• For a brand-new formulation (different strength or delivery), the operative risk becomes bioequivalence and any formulation patents that still have term.

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What Paragraph IV challenges could affect LOPURIN or allopurinol brands?

Answer: A Paragraph IV impact assessment cannot be issued without the specific FDA Orange Book listing and any filed challenges tied to that reference product.

Why Paragraph IV matters

• It accelerates FDA timelines and triggers litigation stay events.
• Settlement agreements can shift market entry timing and prescribing behavior via launch-to-launch bargaining.

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What patent litigation affects LOPURIN (allopurinol), and what settlements are in force?

Answer: Litigation timelines cannot be generated from the input provided because they require patent numbers, party names, and docket outcomes tied to the relevant reference product.

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What is the market size for allopurinol and where does LOPURIN fit competitively?

Answer: A LOPURIN-branded market position cannot be quantified from the input provided. A market analysis for “LOPURIN” requires country and product-level identifiers (NDC/MA number, strength, pack size, marketing authorization holder) and a dataset of brand sales by geography.

Competitive landscape for allopurinol (brand vs generic)

• Allopurinol is typically available as multiple generics across major markets.
• Brand share is usually constrained by substitution and procurement rules.
• Pricing tends toward a low-cost equilibrium where supply and contract tendering dominate.

What drives LOPURIN-specific outcomes

• Presence in formularies and switching rules
• Tendering outcomes for hospitals
• Shelf inventory and distribution agreements

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Revenue projection for LOPURIN: what scenarios exist and what is the base-case?

Answer: Revenue projection cannot be produced for “LOPURIN” without LOPURIN-specific baseline sales, geography, and product configuration.

Projection model structure for a brand like LOPURIN (what inputs are required conceptually)

• Current net sales by country and dosage strength
• Expected generic penetration rates and tender cycles
• Price erosion curve by geography
• Substitution constraints (payer, formulary tiering)
• Supply risks (manufacturing capacity, recalls)

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How does LOPURIN compare with other urate-lowering therapies (febuxostat, probenecid, pegloticase)?

Answer: LOPURIN (allopurinol) is generally first-line due to long clinical use, oral dosing, and cost advantages. The competitive threat from non-allopurinol options depends on patient tolerability and contraindications.

Where non-allopurinol therapies typically win

• Febuxostat for patients who cannot tolerate allopurinol or do not reach urate goals
• Probenecid in selected underexcretors depending on renal function and availability
• Pegloticase for refractory chronic gout where biologic logistics are feasible

Market implication for LOPURIN

• If allopurinol use is constrained by tolerability policies, febuxostat may take share.
• If pricing pressure increases, brand share declines while total molecule volume may remain stable.

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What formulation and manufacturing/IP barriers could delay generic competition for LOPURIN?

Answer: LOPURIN-specific barriers cannot be established from the input provided.

Barriers that can matter in small-molecule tablets

• Proprietary excipient system with documented performance
• Manufacturing scale-up complexity and impurity control
• Any still-active formulation patents
• Stability or dissolution profile requirements tied to approval

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Key Takeaways

• LOPURIN is an allopurinol brand, but the provided input does not contain the identifiers needed to produce a LOPURIN-specific clinical trials update, Orange Book status, patent landscape, or exclusivity-to-generic projection.
• A market analysis and revenue forecast for “LOPURIN” requires geography, strength/dosage form, marketing authorization holder, and reference listing identifiers.
• For business planning, allopurinol competition is typically driven by generic availability and pricing rather than novel clinical differentiation, unless a specific LOPURIN formulation or regional authorization has active IP or procurement advantages.

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FAQs

1. How do allopurinol brands lose formulary position in major markets?
2. What is the typical patient-tolerability pathway from allopurinol to febuxostat?
3. Do bioequivalence requirements eliminate clinical differentiation between LOPURIN and generics?
4. How do hospital tender cycles affect allopurinol brand sales versus generic substitution?
5. What patent types most often survive into late-stage competition for tablet drugs like allopurinol?

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References

No sources were provided in the input, and no jurisdictional/regulatory identifiers were included for LOPURIN.