Viewing data from:

RELEXXII

NDA

METHYLPHENIDATE HYDROCHLORIDE | N216117 | OSMOTICA PHARMACEUTICAL US LLC

7 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Feb. 3, 2037

Feb. 3, 2037

Feb. 3, 2037

Feb. 3, 2037

Feb. 3, 2037

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

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
Sep 25, 2025	SUPPL -3	View Letter (PDF)
Oct 16, 2023	SUPPL -1	View Letter (PDF)
Jun 24, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 18MG

RLD

5 patents0 exclusivities▴