FDA Orange Book

Generic for Hysingla ER

Hysingla ER contains hydrocodone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Hysingla ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Hysingla ER products in the Orange Book

Hysingla ER products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, extended release, oral	100MG	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	120MG	Discontinued	None	1	None
tablet, extended release, oral	20MG	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	30MG	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	40MG	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	60MG	Marketed (Rx)	AB	1	AB
tablet, extended release, oral	80MG	Marketed (Rx)	AB	1	AB

NDA 206627, held by KNOA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic hydrocodone

Approved generic versions of Hysingla ER
Company	ANDA	TE code	Approved	Strengths
ALVOGEN INC	208269	AB (A-rated, therapeutically equivalent)	March 1, 2021	100MG, 120MG, 20MG, 30MG, 40MG, 60MG, 80MG

Hysingla ER patents

Patents listed for Hysingla ER
Patent	Expires	Covers	Use code	NDA
9545380	August 24, 2027	Method of use	U-1556	206627
9095614	August 24, 2027	Method of use	U-1556	206627
9492391	August 24, 2027	Method of use	U-1556	206627
9492390	August 24, 2027	Method of use	U-1556	206627
11304909	August 24, 2027	Method of use	U-1556	206627
9084816	August 24, 2027	Drug product	None	206627
9763933	August 24, 2027	Drug product	None	206627
9486413	August 24, 2027	Drug product	None	206627
9492389	August 24, 2027	Drug product	None	206627
9775809	August 24, 2027	Drug product	None	206627
11304908	August 24, 2027	Drug product	None	206627
9486412	August 24, 2027	Drug product	None	206627
9770416	August 24, 2027	Drug product	None	206627
9095615	August 24, 2027	Drug product	None	206627
8808740	December 21, 2031	Drug product	U-1556	206627
9861584	December 21, 2031	Drug product	None	206627
9572779	December 21, 2031	Drug product	None	206627
9750703	December 21, 2031	Drug product	None	206627
9872837	December 21, 2031	Drug product	None	206627

Hysingla ER NDC codes

Questions

Is there a generic for Hysingla ER?

Yes. The generic name for Hysingla ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Hysingla ER?

The active ingredient in Hysingla ER is hydrocodone, per the FDA Orange Book.

When does the Hysingla ER patent expire?

The last patent listed for Hysingla ER in the Orange Book expires December 21, 2031. 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.