Viewing data from:

RITALIN LA

NDA

METHYLPHENIDATE HYDROCHLORIDE | N021284 | SANDOZ INC

5 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ritalin La (2023)

Total Spending

$1.2M

Total Claims

1,958

Beneficiaries

372

Avg Cost/Unit

$11.94

Spending Trend

$1.3M(2019)→$1.2M(2020)→$1.1M(2021)→$1.0M(2022)→$1.2M(2023)

YoY Change:+11.8%

5yr CAGR:+4.3%

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

21 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -50	View Letter (PDF)
Oct 16, 2023	SUPPL -42	View Letter (PDF)
Oct 16, 2023	SUPPL -46	View Letter (PDF)
Jun 29, 2021	SUPPL -43	View Letter (PDF)
Nov 20, 2019	SUPPL -41	View Letter (PDF)
Jan 18, 2019	SUPPL -29	View Letter (PDF)
Jan 18, 2019	SUPPL -16	View Letter (PDF)
Jan 13, 2017	SUPPL -34	View Letter (PDF)
Apr 21, 2015	SUPPL -27	View Letter (PDF)
Nov 10, 2014	SUPPL -25	View Letter (PDF)
Dec 16, 2013	SUPPL -23	View Letter (PDF)
Jun 11, 2013	SUPPL -19	View Letter (PDF)
May 7, 2013	SUPPL -20	View Letter (PDF)
Dec 15, 2010	SUPPL -18	View Letter (PDF)
Nov 18, 2010	SUPPL -17	View Letter (PDF)
Apr 29, 2010	SUPPL -10	View Letter (PDF)
May 1, 2007	SUPPL -11	View Letter (PDF)
Aug 11, 2006	SUPPL -8	View Letter (PDF)
Aug 11, 2006	SUPPL -6	View Letter (PDF)
Apr 20, 2004	SUPPL -4	View Letter (PDF)
Jun 5, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 20MG

RLDAB1

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jun 5, 2002

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jun 5, 2002

#003 — 40MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jun 5, 2002

#004 — 10MG

RLDAB1

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 10, 2004

#005 — 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 27, 2014