Generic for Jornay PM: Methylphenidate

Yes. The generic name for Jornay PM is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3. Generics match 3 of the 5 Jornay PM products the Orange Book lists.

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Jornay PM products in the Orange Book

Jornay PM products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, extended release, oral	100MG	Marketed (Rx)	None	0	None
capsule, extended release, oral	20MG	Marketed (Rx)	None	6	AB1, AB2, AB3
capsule, extended release, oral	40MG	Marketed (Rx)	None	5	AB1, AB2, AB3
capsule, extended release, oral	60MG	Marketed (Rx)	None	5	AB2, AB1, AB3
capsule, extended release, oral	80MG	Marketed (Rx)	None	0	None

NDA 209311, held by IRONSHORE PHARMACEUTICALS INC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic methylphenidate

Approved generic versions of Jornay PM
Company	ANDA	TE code	Approved	Strengths
DR REDDYS LABORATORIES SA	078458	AB1 (A-rated, therapeutically equivalent)	December 1, 2011	20MG, 40MG, 60MG
TEVA PHARMACEUTICALS USA	077707	AB2 (A-rated, therapeutically equivalent)	July 19, 2012	20MG
SPECGX LLC	203583	AB2 (A-rated, therapeutically equivalent)	September 29, 2015	20MG, 40MG, 60MG
IMPAX LABORATORIES INC	205105	AB2 (A-rated, therapeutically equivalent)	July 28, 2016	20MG, 40MG, 60MG
ACTAVIS ELIZABETH LLC	208861	AB3 (A-rated, therapeutically equivalent)	December 13, 2018	20MG, 40MG, 60MG
GRANULES PHARMACEUTICALS INC	211796	AB1 (A-rated, therapeutically equivalent)	May 23, 2019	20MG, 40MG, 60MG

Jornay PM patents

Patents listed for Jornay PM
Patent	Expires	Covers	Use code	NDA
10292937	March 23, 2032	Method of use	U-2357	209311
9603809	March 23, 2032	Method of use	U-2357	209311
8916588	March 23, 2032	Method of use	U-2357	209311
9028868	March 23, 2032	Method of use	U-2357	209311
10617651	March 23, 2032	Method of use	U-2357	209311
9034902	March 23, 2032	Method of use	U-2357	209311
10881618	March 23, 2032	Method of use	U-2357	209311
11911518	March 23, 2032	Method of use	U-2357	209311
11241391	March 23, 2032	Method of use	U-2357	209311
11241392	March 23, 2032	Drug product	None	209311
9498447	March 23, 2032	Drug product	None	209311
9283214	March 23, 2032	Drug product	None	209311
9023389	March 23, 2032	Drug product	None	209311
10905652	March 23, 2032	Drug product	None	209311
8927010	March 23, 2032	Drug product	None	209311
10182995	March 23, 2032	Drug product	None	209311

Jornay PM NDC codes

Questions

Is there a generic for Jornay PM?

Yes. The generic name for Jornay PM is methylphenidate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3. Generics match 3 of the 5 Jornay PM products the Orange Book lists.

What is the generic name for Jornay PM?

The active ingredient in Jornay PM is methylphenidate, per the FDA Orange Book.

When does the Jornay PM patent expire?

The last patent listed for Jornay PM in the Orange Book expires March 23, 2032. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

Generic for Jornay PM