Viewing data from:

RITALIN

NDA

METHYLPHENIDATE HYDROCHLORIDE | N010187 | SANDOZ INC

3 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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue NCT06905587	Phase 3	Recruiting	Odense University Hospital	50	2025-09-02 → 2029-12
Brain Dopaminergic Signaling in Opioid Use Disorders NCT03190954	Early Phase 1	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	153	2017-08-17 → 2025-10-27

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

Medicare Part D Spending

CMS annual spending data for Ritalin (2023)

Total Spending

$756K

Total Claims

5,923

Beneficiaries

1,216

Avg Cost/Unit

$1.28

Spending Trend

$926K(2019)→$951K(2020)→$940K(2021)→$914K(2022)→$756K(2023)

YoY Change:+6.7%

5yr CAGR:+2.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs5 inactive

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

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 101371993

SPECGX LLCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 127691997

CAMBREX CHARLES CITY INCMETHYLPHENIDATE HYDROCHLORIDE (RITALIN HCL)

DMF 166102003

CURIA MISSOURI INCMETHYLPHENIDATE HYDROCHLORIDE USP

DMF 190632005

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

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

19 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2025	SUPPL -94	View Letter (PDF)
Oct 16, 2023	SUPPL -96	View Letter (PDF)
Oct 16, 2023	SUPPL -92	View Letter (PDF)
Jun 29, 2021	SUPPL -93	View Letter (PDF)
Nov 20, 2019	SUPPL -91	View Letter (PDF)
Jan 18, 2019	SUPPL -71	View Letter (PDF)
Jan 18, 2019	SUPPL -82	View Letter (PDF)
Jan 13, 2017	SUPPL -87	View Letter (PDF)
Apr 21, 2015	SUPPL -80	View Letter (PDF)
Dec 16, 2013	SUPPL -77	View Letter (PDF)
Jun 11, 2013	SUPPL -74	View Letter (PDF)
Dec 15, 2010	SUPPL -73	View Letter (PDF)
Nov 18, 2010	SUPPL -72	View Letter (PDF)
May 1, 2007	SUPPL -69	View Letter (PDF)
Aug 11, 2006	SUPPL -66	View Letter (PDF)
Aug 11, 2006	SUPPL -67	View Letter (PDF)
May 27, 2004	SUPPL -58	View Letter (PDF)
May 27, 2004	SUPPL -57	View Letter (PDF)
Jan 11, 2002	SUPPL -60	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 5MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#006 — 10MG

RLDAB

0 patents0 exclusivities▾

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

#010 — 20MG

RLDAB

0 patents0 exclusivities▾

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