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THIOGUANINE

NDA

THIOGUANINE | N012429 | WAYLIS THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Buchanan Ingersoll & Rooney PC FDA-2025-P-0919 · 5 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition under 21 C.F.R. § 10.30 regarding TABLOID (thioguanine) 40 mg tablets, NDA 012429, requesting that the FDA maintain and strictly apply the product-specific guidance requirements to any ANDA for thioguanine tablets, particularly ensuring in v	505(q)	2025-03-25	Open	Buchanan Ingersoll & Rooney PC
Citizen Petition from Buchanan Ingersoll & Rooney PC FDA-2025-P-0393 · 5 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition on February 3, 2025, requesting that the FDA maintain and strictly apply the current product-specific guidance for thioguanine tablets to all pending and future ANDAs for thioguanine, ensuring in vivo bioequivalence studies are required prio	505(q)	2025-02-05	Withdrawn	Buchanan Ingersoll & Rooney PC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

78 trials from ClinicalTrials.gov — 4 recruiting, 6 active, 53 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma NCT02112916	Phase 3	Active	National Cancer Institute (NCI)	847	2014-10-04 → 2026-09-16
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma NCT03117751	Phase 2/3	Active	St. Jude Children's Research Hospital	790	2017-03-29 → 2028-09-30
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome NCT02521493	Phase 3	Active	Children's Oncology Group	280	2015-12-23 → 2026-06-30
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia NCT02101853	Phase 3	Active	National Cancer Institute (NCI)	669	2014-12-17 → 2026-09-16
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia NCT03914625	Phase 3	Active	National Cancer Institute (NCI)	6,720	2019-07-03 → 2027-09-30
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia NCT03571321	Phase 1	Recruiting	University of Chicago	15	2019-05-28 → 2027-09-05
International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma NCT04043494	Phase 3	Recruiting	University Hospital Muenster	683	2019-08-23 → 2030-04-22
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy NCT03959085	Phase 3	Recruiting	Children's Oncology Group	5,951	2019-10-31 → 2032-03-31
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia NCT03150693	Phase 3	Recruiting	Alliance for Clinical Trials in Oncology	303	2017-09-20 → 2027-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Tabloid (2024)

Total Spending

$839K

Total Claims

Beneficiaries

Avg Cost/Unit

$504.64

Spending Trend

$230K(2022)→$300K(2023)→$839K(2024)

YoY Change:+18.2%

5yr CAGR:+18.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jul 10, 2024	SUPPL -29	View Letter (PDF)
May 24, 2018	SUPPL -28	View Letter (PDF)
Nov 16, 2004	SUPPL -22	View Letter (PDF)
Dec 24, 2003	SUPPL -21	View Letter (PDF)
Jul 6, 2003	SUPPL -19	View Letter (PDF)
May 8, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.