Viewing data from:

CONCERTA

NDA

METHYLPHENIDATE HYDROCHLORIDE | N021121 | JANSSEN PHARMACEUTICALS INC

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Alza Corporation et al v. Amneal Pharmaceuticals of New York, LLC et al 1:2016cv00914 2 patentsANDA 207515methylphenidate hydrochloride	D. Del.	2016-10-07	Terminated 2017-07-27	—
MYLAN PHARMACEUTICALS INC. v. JANSSEN PHARMACEUTICALS, INC. 2:2015cv02990 2 patentsANDA 20-6726methylphenidate hydrochloride extended-release	E.D. Pa.	2015-05-29	Terminated 2015-10-16	—
ALZA CORPORATION et al v. SANDOZ INC. 1:2014cv03838 2 patentsANDA 205714methylphenidate hydrochloride	D.N.J.	2014-06-16	Terminated 2014-09-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Concerta (2023)

Total Spending

$14.7M

Total Claims

26,513

Beneficiaries

6,062

Avg Cost/Unit

$14.16

Spending Trend

$5.4M(2019)→$5.0M(2020)→$5.3M(2021)→$6.6M(2022)→$14.7M(2023)

YoY Change:+5.6%

5yr CAGR:+9.1%

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

20 letters from Drugs@FDA

Date	Submission	Document
Apr 13, 2026	SUPPL -54	View Letter (PDF)
Sep 25, 2025	SUPPL -53	View Letter (PDF)
Oct 16, 2023	SUPPL -49	View Letter (PDF)
Jun 29, 2021	SUPPL -44	View Letter (PDF)
Jan 11, 2017	SUPPL -38	View Letter (PDF)
Apr 21, 2015	SUPPL -35	View Letter (PDF)
Dec 16, 2013	SUPPL -32	View Letter (PDF)
Jun 14, 2013	SUPPL -31	View Letter (PDF)
May 7, 2013	SUPPL -29	View Letter (PDF)
Nov 30, 2010	SUPPL -27	View Letter (PDF)
Nov 30, 2010	SUPPL -26	View Letter (PDF)
Jan 25, 2010	SUPPL -22	View Letter (PDF)
Jul 1, 2008	SUPPL -17	View Letter (PDF)
Jul 1, 2008	SUPPL -15	View Letter (PDF)
May 9, 2007	SUPPL -14	View Letter (PDF)
Sep 18, 2006	SUPPL -12	View Letter (PDF)
Sep 18, 2006	SUPPL -9	View Letter (PDF)
Oct 29, 2004	SUPPL -8	View Letter (PDF)
Apr 1, 2002	SUPPL -4	View Letter (PDF)
Aug 1, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 18MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 1, 2000

No patent or exclusivity listings for this strength.

#002 — 36MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 1, 2000

#003 — 54MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 8, 2000

#004 — 27MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 1, 2002