Viewing data from:

FOCALIN XR

NDA

DEXMETHYLPHENIDATE HYDROCHLORIDE | N021802 | SANDOZ INC

8 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Alkermes Pharma Ireland Limited v. Intellipharmaceutics Corporation et al 1:2012cv00834 2 patentsANDA 78992dexmethylphenidate hydrochloride	D. Del.	2012-06-29	Terminated 2013-05-21	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions NCT00829712	Phase 1	Completed	Teva Pharmaceuticals USA	24	2004-06 → 2004-06
CTx-1301 Comparative Bioavailability Study NCT04138498	Phase 1/2	Completed	Cingulate Therapeutics	45	2019-12-06 → 2020-03-06
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder NCT00301236	Phase 3	Completed	Novartis	252	2006-02 → 2006-11
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions NCT00829673	Phase 1	Completed	Teva Pharmaceuticals USA	24	2004-06 → 2004-06
Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits NCT01399827	Phase 2	Completed	Massachusetts General Hospital	2	2012-02 → 2017-11
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR NCT00393042	Phase 3	Completed	Seattle Children's Hospital	77	2006-01 → 2009-02

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 19 NDCs

Highest NADAC/Unit

$5.43

per ea

Lowest NADAC/Unit

$4.70

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078060905FOCALIN XR 35 MG CAPSULE	$5.43	EA	Brand	$2.04	2025-10-22
66758024131FOCALIN XR 35 MG CAPSULE	$5.43	EA	Brand	$2.04	2026-01-14
66758024201FOCALIN XR 40 MG CAPSULE	$5.41	EA	Brand	$1.93	2026-06-17
66758024231FOCALIN XR 40 MG CAPSULE	$5.41	EA	Brand	$1.93	2026-06-17
66758023931FOCALIN XR 25 MG CAPSULE	$5.14	EA	Brand	$1.99	2026-06-17
00078060805FOCALIN XR 25 MG CAPSULE	$5.14	EA	Brand	$1.99	2026-06-17

Showing 6 of 19 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (14 FSS)

Lowest Price

$147.52

Highest Price

$417.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66758-0242-01FOCALIN XR 40MG CAP	$417.02	FSS	Sandoz, Inc.	08/14/2028
00078-0433-05FOCALIN XR 30MG CAP	$367.89	FSS	Sandoz, Inc.	08/14/2028
00078-0609-05FOCALIN XR 35MG CAP	$394.47	FSS	Sandoz, Inc.	08/14/2028
66758-0235-01FOCALIN XR 5MG CAP	$364.15	FSS	Sandoz, Inc.	08/14/2028
66758-0235-31FOCALIN XR 5MG CAP	$147.52	FSS	Sandoz, Inc.	08/14/2028
66758-0238-01FOCALIN XR 20MG CAP	$382.95	FSS	Sandoz, Inc.	08/14/2028

Showing 6 of 14 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Focalin XR (2024)

Total Spending

$1.1M

Total Claims

3,848

Beneficiaries

939

Avg Cost/Unit

$7.64

Spending Trend

$1.1M(2019)→$1.2M(2020)→$1.2M(2021)→$1.4M(2022)→$1.9M(2023)→$1.1M(2024)

YoY Change:-48.2%

5yr CAGR:-12.8%

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

API Supply Chain6 active DMFs

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

SIEGFRIED USA LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 132281998

LONZA INCDEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)

DMF 171172004

CURIA MISSOURI INCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 203852007

PURISYS LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 294112016

SPECGX LLCDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 306572016

ALKEM LABORATORIES LTDDEXMETHYLPHENIDATE HYDROCHLORIDE

DMF 329022018

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

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -45	View Letter (PDF)
Oct 16, 2023	SUPPL -38	View Letter (PDF)
Oct 16, 2023	SUPPL -41	View Letter (PDF)
Jun 29, 2021	SUPPL -39	View Letter (PDF)
Nov 20, 2019	SUPPL -36	View Letter (PDF)
Jan 18, 2019	SUPPL -29	View Letter (PDF)
Jan 18, 2019	SUPPL -19	View Letter (PDF)
Jan 10, 2017	SUPPL -33	View Letter (PDF)
Apr 20, 2015	SUPPL -28	View Letter (PDF)
Dec 13, 2013	SUPPL -26	View Letter (PDF)
Jun 12, 2013	SUPPL -25	View Letter (PDF)
May 4, 2012	SUPPL -24	View Letter (PDF)
Nov 22, 2010	SUPPL -21	View Letter (PDF)
May 7, 2010	SUPPL -17	View Letter (PDF)
Dec 11, 2009	SUPPL -14	View Letter (PDF)
Dec 11, 2009	SUPPL -16	View Letter (PDF)
Oct 22, 2008	SUPPL -12	View Letter (PDF)
May 1, 2007	SUPPL -9	View Letter (PDF)
Aug 4, 2006	SUPPL -7	View Letter (PDF)
Aug 4, 2006	SUPPL -3	View Letter (PDF)
Apr 13, 2006	SUPPL -1	View Letter (PDF)
Apr 13, 2006	SUPPL -5	View Letter (PDF)
Jun 7, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 26, 2005

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 26, 2005

#003 — 20MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 26, 2005

#004 — 15MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 1, 2006

#005 — 30MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Oct 23, 2009

#006 — 40MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 11, 2010

#007 — 35MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 21, 2011

#008 — 25MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 21, 2011