Is there a generic for Hydrocodone bitartrate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Hydrocodone bitartrate, referencing the brand VANTRELA ER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydrocodone bitartrate?

VANTRELA ER (NDA 207975, TEVA BRANDED PHARM) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Hydrocodone bitartrate?

The Orange Book lists 38 patents against Hydrocodone bitartrate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Hydrocodone bitartrate are approved?

Hydrocodone bitartrate is approved in the following dosage forms: capsule, extended release, tablet, extended release.

FDA Orange Book · active-ingredient family

Hydrocodone bitartrate

Hydrocodone bitartrate: 3 brands, 2 generics; first approved Oct 25, 2013; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Aug 24, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 24, 2027

in 11 mo

Brand (NDA) products

Originator applications

VANTRELA ERRLD

TEVA BRANDED PHARMNDA 20797520175 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
15MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
30MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
45MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
60MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
90MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

HYSINGLA ERRLDRS

KNOA PHARMANDA 20662720147 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
30MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
40MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
60MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
80MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
100MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
120MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

ZOHYDRO ERRLD

RECRO GAINESVILLENDA 20288020136 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
15MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	—

Generic (ANDA) products (2)

Abbreviated applications

HYDROCODONE BITARTRATE

ALVOGENANDA 20826920217 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
30MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
40MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
60MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
80MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
100MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
120MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—

HYDROCODONE BITARTRATERS

ALVOGENANDA 20698620206 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
15MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9545380	Aug 24, 2027	in 11 mo	U-1556
9095614	Aug 24, 2027	in 11 mo	U-1556
9492391	Aug 24, 2027	in 11 mo	U-1556
9492390	Aug 24, 2027	in 11 mo	U-1556
11304909	Aug 24, 2027	in 11 mo	U-1556
9084816	Aug 24, 2027	in 11 mo	Product
9763933	Aug 24, 2027	in 11 mo	Product
9486413	Aug 24, 2027	in 11 mo	Product
9492389	Aug 24, 2027	in 11 mo	Product
9775809	Aug 24, 2027	in 11 mo	Product
11304908	Aug 24, 2027	in 11 mo	Product
9486412	Aug 24, 2027	in 11 mo	Product
9770416	Aug 24, 2027	in 11 mo	Product
9095615	Aug 24, 2027	in 11 mo	Product
9216176	Sep 13, 2027	in 11 mo	Product
9572803	Sep 13, 2027	in 11 mo	Product
8445018	Jul 31, 2029	in 2 yr 10 mo	Product
8808740	Dec 21, 2031	in 5 yr 3 mo	ProductU-1556
9861584	Dec 21, 2031	in 5 yr 3 mo	Product
9572779	Dec 21, 2031	in 5 yr 3 mo	Product
9750703	Dec 21, 2031	in 5 yr 3 mo	Product
9872837	Dec 21, 2031	in 5 yr 3 mo	Product
9326982	Jul 25, 2033	in 6 yr 11 mo	U-1810
9339499	Jul 25, 2033	in 6 yr 11 mo	U-1810
10456393	Jul 25, 2033	in 6 yr 11 mo	U-1810
10028946	Jul 25, 2033	in 6 yr 11 mo	U-1810
9265760	Jul 25, 2033	in 6 yr 11 mo	U-1810
9433619	Jul 25, 2033	in 6 yr 11 mo	U-1810
10722511	Jul 25, 2033	in 6 yr 11 mo	U-1810
9610286	Jul 25, 2033	in 6 yr 11 mo	U-1810
9421200	Jul 25, 2033	in 6 yr 11 mo	U-1810
9333201	Jul 25, 2033	in 6 yr 11 mo	U-1810
10322120	Jul 25, 2033	in 6 yr 11 mo	Product
9713611	Sep 12, 2034	in 8 yr 1 mo	ProductU-55
9486451	Sep 12, 2034	in 8 yr 1 mo	U-55
9452163	Sep 12, 2034	in 8 yr 1 mo	U-55
10092559	Sep 12, 2034	in 8 yr 1 mo	U-55
9132096	Sep 12, 2034	in 8 yr 1 mo	Product

Approval history

FDA approval span

First approval

Oct 25, 2013

13 yr 2 mo ago

Most recent approval

Mar 01, 2021

5 yr 8 mo ago

Approvals span 2013–2021 across 5 FDA applications.

Brand (NDA) 360%

Generic (ANDA) 240%

Hydrocodone bitartrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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