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DESOXYN

NDA

METHAMPHETAMINE HYDROCHLORIDE | N005378 | AJENAT PHARMACEUTICALS LLC

4 strengths0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
tTIS Targeted of the Striatum as an Intervention for MUD Patients NCT07479771	N/A	Active	Shanghai Mental Health Center	53	2026-03-26 → 2026-06-30
Methamphetamine Isomer Pharmacology in Humans NCT06746831	Phase 1	Not Yet Recruiting	University of Wisconsin, Madison	17	2026-07 → 2028-03
Cerebellum-Prefrontal Paired-Pulse Stimulation for Methamphetamine Use Disorder NCT06457230	N/A	Recruiting	Shanghai Mental Health Center	90	2024-12-24 → 2026-09

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHATTEM CHEMICALS INCMETHAMPHETAMINE HYDROCHLORIDE USP

DMF 161762002

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 5MG

RLDAA

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 10MG

0 patents0 exclusivities▾

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

#004 — 5MG

0 patents0 exclusivities▾

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

#005 — 15MG

0 patents0 exclusivities▾

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