Is there a generic for Apomorphine hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Apomorphine hydrochloride, referencing the brand ONAPGO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Apomorphine hydrochloride?

ONAPGO (NDA 214056, MDD US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Apomorphine hydrochloride?

The Orange Book lists 12 patents against Apomorphine hydrochloride products, with the earliest listed expiry in 2029. 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.

Does Apomorphine hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Apomorphine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Apomorphine hydrochloride are approved?

Apomorphine hydrochloride is approved in the following dosage forms: film, injectable, solution.

FDA Orange Book · active-ingredient family

Apomorphine hydrochloride

Apomorphine hydrochloride: 3 brands, 1 generic; first approved Apr 20, 2004; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Aug 07, 2029Latest exclusivity ends Feb 03, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 07, 2029

in 3 yr 1 mo

Originator applications

Brand (NDA) products

ONAPGORLDRS

MDD USNDA 2140562025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
98MG/20ML (4.9MG/ML)	SOLUTION	SUBCUTANEOUS	Rx	—

KYNMOBIRLD

SUMITOMO PHARMA AMNDA 21087520205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	FILM	SUBLINGUAL	Discontinued	—
15MG	FILM	SUBLINGUAL	Discontinued	—
20MG	FILM	SUBLINGUAL	Discontinued	—
25MG	FILM	SUBLINGUAL	Discontinued	—
30MG	FILM	SUBLINGUAL	Discontinued	—

APOKYNRLDRS

MDD USNDA 02126420042 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/2ML (10MG/ML)	INJECTABLE	SUBCUTANEOUS	Discontinued	—
30MG/3ML (10MG/ML)	INJECTABLE	SUBCUTANEOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (1)

APOMORPHINE HYDROCHLORIDE

TP ANDA HOLDINGSANDA 2120252022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/3ML (10MG/ML)	INJECTABLE	SUBCUTANEOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

NPNew product exclusivity (3 years)
Feb 03, 2028
in 1 yr 7 mo

Orange Book patent file

Listed patents

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10821074	Aug 07, 2029	in 3 yr 1 mo	Product
9669021	Jun 11, 2030	in 4 yr	U-2825
9669019	Jun 11, 2030	in 4 yr	ProductU-2825
9283219	Jun 11, 2030	in 4 yr	ProductU-2825
10420763	Jun 11, 2030	in 4 yr	ProductU-2825
9326981	Jun 11, 2030	in 4 yr	U-2825
9044475	Jun 11, 2030	in 4 yr	Product
11419769	Dec 16, 2031	in 5 yr 6 mo	ProductU-2825
8414922	Dec 16, 2031	in 5 yr 6 mo	ProductU-2825
8846074	Dec 16, 2031	in 5 yr 6 mo	ProductU-2825
10449146	Apr 19, 2036	in 9 yr 11 mo	U-2825
10959943	Apr 19, 2036	in 9 yr 11 mo	U-2825

FDA approval span

Approval history

First approval

Apr 20, 2004

22 yr 7 mo ago

Most recent approval

Feb 03, 2025

1 yr 5 mo ago

Approvals span 2004–2025 across 4 FDA applications.

Brand (NDA) 375%

Generic (ANDA) 125%

Apomorphine hydrochloride — 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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