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METHYLPHENIDATE

ANDA

METHYLPHENIDATE | A206497 | MYLAN TECHNOLOGIES INC A VIATRIS CO

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DAYTRANA(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Exhibit E A Comparison of Once Daily Extended-Release Methylphenidate Formula... FDA-2005-P-0120	Other	2012-04-12	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Methylphenidate (2023)

Total Spending

$371K

Total Claims

858

Beneficiaries

229

Avg Cost/Unit

$12.64

Spending Trend

$109K(2022)→$371K(2023)

YoY Change:-4.3%

5yr CAGR:-4.3%

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

API Supply Chain9 active DMFs1 inactive

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

SPECGX LLCMETHYLPHENIDATE BASE

DMF 131321998

CHATTEM CHEMICALS INCMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 163312002

CHATTEM CHEMICALS INCMETHYLPHENIDATE BASE

DMF 176682004

VERANOVA LPMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 195472006

VERANOVA LPMETHYLPHENIDATE FREE BASE

DMF 229392009

TRIS PHARMA INCMETHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)

DMF 238702010

TRIS PHARMA INCMETHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)

DMF 259092012

NORAMCO LLCMETHYLPHENIDATE HCL USP

DMF 272082013

AMPAC FINE CHEMICALS LLCMETHYLPHENIDATE HCI

DMF 301162016

UCB INCInactiveMETHYLPHENIDATE HYDROCHLORIDE, USP

DMF 116351995

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 9, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG/9HR (1.1MG/HR)

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Mar 14, 2022

No patent or exclusivity listings for this strength.

#002 — 15MG/9HR (1.6MG/HR)

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Mar 14, 2022

#003 — 20MG/9HR (2.2MG/HR)

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Mar 14, 2022

#004 — 30MG/9HR (3.3MG/HR)

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Mar 14, 2022