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METHYLIN

NDA

METHYLPHENIDATE HYDROCHLORIDE | N021419 | SPECGX LLC

2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

286 trials from ClinicalTrials.gov — 5 recruiting, 5 active, 208 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer NCT03772834	Phase 2/3	Active	M.D. Anderson Cancer Center	200	2019-03-25 → 2026-11-30
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness NCT03814356	Phase 1	Active	Massachusetts General Hospital	10	2020-08-24 → 2026-06-30
A Study of Cancer Related Fatigue in Patients With Metastatic Cancer Receiving Anti-PD1 Immunotherapy NCT03525873	Phase 3	Active	M.D. Anderson Cancer Center	212	2018-08-02 → 2026-12-31
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer NCT01628029	Phase 2	Active	M.D. Anderson Cancer Center	68	2014-01-15 → 2028-12-31
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy NCT01410942	Phase 2	Active	M.D. Anderson Cancer Center	175	2012-02-08 → 2026-09-30
Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children NCT03425669	N/A	Recruiting	Lund University	70	2019-05-01 → 2027-05-31
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk NCT03781765	Phase 4	Recruiting	Icahn School of Medicine at Mount Sinai	44	2019-06-04 → 2025-09-25
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD NCT03781752	Phase 4	Recruiting	Icahn School of Medicine at Mount Sinai	500	2018-03-04 → 2025-08
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome NCT00768820	Phase 4	Recruiting	The Chaim Sheba Medical Center	400	2001-05 → 2027-08
Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder NCT02951754	Phase 4	Recruiting	Hospital de Clinicas de Porto Alegre	600	2002-02 → 2032-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.2317

per ml

Lowest NADAC/Unit

$0.1618

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59630075550METHYLIN 10 MG/5 ML SOLUTION	$0.2317	ML	Brand	$0.1106	2026-01-01
59630075050METHYLIN 5 MG/5 ML SOLUTION	$0.1618	ML	Brand	$0.0792	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$51.06

Highest Price

$101.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59630-0755-50METHYLIN 10MG/5ML ORAL SOLN	$101.46	FSS	Shionogi Inc.	08/31/2028
59630-0755-50METHYLIN 10MG/5ML ORAL SOLN	$73.08	Big4	Shionogi Inc.	08/31/2028
59630-0750-50METHYLIN 5MG/5ML ORAL SOLN	$71.02	FSS	Shionogi Inc.	08/31/2028
59630-0750-50METHYLIN 5MG/5ML ORAL SOLN	$51.06	Big4	Shionogi Inc.	08/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Methylin (2024)

Total Spending

$3K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$0.16

Spending Trend

$4K(2019)→$2K(2021)→$3K(2022)→$4K(2023)→$3K(2024)

YoY Change:-6.2%

5yr CAGR:-7.2%

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

API Supply Chain12 active DMFs6 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 101371993

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 127691997

CHATTEM CHEMICALS INCMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 163312002

CAMBREX CHARLES CITY INCMETHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL)

DMF 166102003

CURIA MISSOURI INCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 190632005

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 195472006

NORAMCO LLCMETHYLPHENIDATE HYDROCHLORIDE

DMF 222442008

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP (NP)

DMF 257762013

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS I)

DMF 305102016

JANSSEN RESEARCH AND DEVELOPMENT LLCMETHYLPHENIDATE HYDROCHLORIDE DRUG SUBSTANCE (PROCESS II)

DMF 305462021

ALKEM LABORATORIES LTDMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 306822016

SIEGFRIED USA LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 342742019

UCB INCInactiveMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 116351995

SIEGFRIED USA LLCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 129891998

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 154852001

IPCA LABORATORIES LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 206212007

MACFARLAN SMITH LTDInactiveMETHYLPHENIDATE HYDROCHLORIDE

DMF 305792016

CODY LABORATORIES INCInactiveMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 335092019

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Oct 16, 2023	SUPPL -23	View Letter (PDF)
Jul 20, 2021	SUPPL -10	View Letter (PDF)
Jun 29, 2021	SUPPL -20	View Letter (PDF)
Jan 13, 2017	SUPPL -14	View Letter (PDF)
Apr 20, 2015	SUPPL -9	View Letter (PDF)
Dec 24, 2013	SUPPL -7	View Letter (PDF)
Jun 18, 2013	SUPPL -6	View Letter (PDF)
Oct 20, 2010	SUPPL -4	View Letter (PDF)
Jun 14, 2007	SUPPL -1	View Letter (PDF)
Aug 14, 2006	SUPPL -3	View Letter (PDF)
Dec 19, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG/5ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 19, 2002

No patent or exclusivity listings for this strength.

#002 — 10MG/5ML

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Dec 19, 2002