Is there a generic for Naloxone hydrochloride?

Yes. The FDA Orange Book lists 77 approved generic (ANDA) applications for Naloxone hydrochloride, referencing the brand KLOXXADO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Naloxone hydrochloride?

KLOXXADO (NDA 212045, HIKMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Naloxone hydrochloride?

The Orange Book lists 37 patents against Naloxone hydrochloride products, with the earliest listed expiry in 2026. 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 Naloxone hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Naloxone 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 Naloxone hydrochloride are approved?

Naloxone hydrochloride is approved in the following dosage forms: injectable, solution, spray, spray, metered.

FDA Orange Book · active-ingredient family

Naloxone hydrochloride

Naloxone hydrochloride: 10 brands, 77 generics; first approved Jun 14, 1982; generic available.

Generic available2 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 77 ANDA applications approved.

Earliest patent expiry Feb 01, 2026Latest exclusivity ends Apr 19, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 01, 2026

8 mo ago

Brand (NDA) products

Originator applications

KLOXXADORLD
HIKMANDA 21204520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8MG/SPRAY SPRAY NASAL Rx —
4MG/SPRAY SPRAY NASAL Rx —
REZENOPYRLDRS
SCIENTURENDA 2154872024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/SPRAY SPRAY NASAL Rx —
RIVIVERLDRS
HARM REDUCTION THERPNDA 2177222023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3MG/SPRAY SPRAY, METERED NASAL OTC —
REXTOVYRLDRS
AMPHASTAR PHARMS INCNDA 2089692023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG/SPRAY SPRAY, METERED NASAL OTC —
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)RLD
KALEO INCNDA 2154572022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/0.4ML (10MG/0.4ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Discontinued —
ZIMHIRLDRS
ZMI PHARMANDA 2128542021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/0.5ML (5MG/0.5ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Rx —
NARCANRLD
EMERGENTNDA 20841120172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG/SPRAY SPRAY, METERED NASAL OTC —
2MG/SPRAY SPRAY, METERED NASAL Discontinued —
EVZIO (AUTOINJECTOR)RLD
KALEO INCNDA 2098622016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/0.4ML (2MG/0.4ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Discontinued —
EVZIORLD
KALEO INCNDA 2057872014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/0.4ML (0.4MG/0.4ML) SOLUTION INTRAMUSCULAR, SUBCUTANEOUS Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/SPRAY	SPRAY	NASAL	Rx	—
4MG/SPRAY	SPRAY	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/SPRAY	SPRAY	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/0.4ML (10MG/0.4ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/0.5ML (5MG/0.5ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/SPRAY	SPRAY, METERED	NASAL	OTC	—
2MG/SPRAY	SPRAY, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/0.4ML (2MG/0.4ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—

NARCANRLD

ADAPTNDA 016636—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Discontinued	—
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (77)

Abbreviated applications

NALOXONE HYDROCHLORIDE
STERINOVA INCANDA 21994220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
STERINOVA INCANDA 2142112025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
PADAGIS ISRAELANDA 2167192025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8MG/SPRAY SPRAY NASAL Discontinued —
NALOXONE HYDROCHLORIDE
AMNEALANDA 2179922024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG/SPRAY SPRAY, METERED NASAL OTC —
NALOXONE HYDROCHLORIDE
FRESENIUS KABI USAANDA 21357320242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
HIKMAANDA 21230020242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
MANKIND PHARMAANDA 2184042024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
BPI LABSANDA 2169772023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
BAXTER HLTHCARE CORPANDA 2147922022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
ACCORD HLTHCAREANDA 21662420222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
PH HEALTHANDA 2159642022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
PADAGIS ISRAELANDA 2119512022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG/SPRAY SPRAY, METERED NASAL OTC —
NALOXONE HYDROCHLORIDE
MYLAN LABS LTDANDA 2138432022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
BAXTER HLTHCARE CORPANDA 21478520212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
EUGIA PHARMAANDA 2132792021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
DR REDDYSANDA 2132092020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
PH HEALTHANDA 2112862020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
EUGIA PHARMAANDA 2124562019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
EUGIA PHARMAANDA 2124552019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
TEVA PHARMS USAANDA 2095222019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4MG/SPRAY SPRAY, METERED NASAL OTC —
NALOXONE HYDROCHLORIDE
CHARTWELL RXANDA 2078462018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SOMERSET THERAPS LLCANDA 2076332017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
SOMERSET THERAPS LLCANDA 2076342017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
RISINGANDA 2088722017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
RISINGANDA 2088712017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
MYLAN INSTITUTIONALANDA 2050142016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
MYLAN INSTITUTIONALANDA 2049972014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
ASTRAZENECAANDA 0720811989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720821989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720831989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720841989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720851989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720861989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720871989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720881989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720891989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720901989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720911989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720921989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
IGI LABS INCANDA 0720931989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
ABRAXIS PHARMANDA 0716041988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NARCAN
BRISTOL MYERS SQUIBBANDA 0710831988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NARCAN
BRISTOL MYERS SQUIBBANDA 0710841988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NARCAN
BRISTOL MYERS SQUIBBANDA 0713111988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
MARSAM PHARMS LLCANDA 0718111988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HIKMAANDA 0712721988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HIKMAANDA 0712731988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HIKMAANDA 0712741988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HIKMAANDA 0712871988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
INTL MEDICATIONANDA 0721151988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDERS
INTL MEDICATIONANDA 0720761988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
WATSON LABSANDA 0713391987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SMITH AND NEPHEWANDA 0716711987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SMITH AND NEPHEWANDA 0716811987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SMITH AND NEPHEWANDA 0716821987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SOLOPAKANDA 0716721987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
SOLOPAKANDA 0716831987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HOSPIRAANDA 0702521987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HOSPIRAANDA 0702531987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HOSPIRAANDA 0702541987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HOSPIRAANDA 0702551987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDERS
HOSPIRAANDA 0702561987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDERS
HOSPIRAANDA 0702571987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
ABRAXIS PHARMANDA 0706481986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
ABRAXIS PHARMANDA 0706611986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
ABRAXIS PHARMANDA 0706491986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
HIKMAANDA 0702981986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
HIKMAANDA 0702991986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE
HIKMAANDA 0704961986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
WYETH AYERSTANDA 0701881986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
WYETH AYERSTANDA 0701891986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
WYETH AYERSTANDA 0701901986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE
WYETH AYERSTANDA 0701911986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
HOSPIRAANDA 0701711986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDERS
HOSPIRAANDA 0701721986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Rx AP
NALOXONE HYDROCHLORIDE
INTL MEDICATIONANDA 0704171986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —
NALOXONE HYDROCHLORIDE
INTL MEDICATIONANDA 0706391986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.4MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8MG/SPRAY	SPRAY	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4MG/SPRAY	SPRAY, METERED	NASAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML	INJECTABLE	INJECTION	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Mar 07, 2026
7 mo ago
NPNew product exclusivity (3 years)
Apr 19, 2027
in 7 mo

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
9278182	Feb 01, 2026	8 mo ago	Product
8926594	Mar 31, 2026	6 mo ago	Product
7731686	Jun 10, 2026	3 mo ago	Product
10960155	Jun 25, 2026	3 mo ago	Product
11590286	Dec 12, 2026	in 3 mo	Product
9238108	Feb 20, 2027	in 5 mo	Product
8206360	Feb 27, 2027	in 5 mo	Product
9724471	May 23, 2027	in 8 mo	ProductU-2092
7947017	Mar 12, 2028	in 1 yr 6 mo	Product
7749194	Oct 30, 2028	in 2 yr 2 mo	Product
8231573	Nov 25, 2028	in 2 yr 3 mo	Product
8226610	Apr 10, 2029	in 2 yr 7 mo	Product
8021344	Nov 02, 2029	in 3 yr 2 mo	Product
9474869	Feb 28, 2031	in 4 yr 6 mo	ProductU-1907
10322239	Feb 28, 2031	in 4 yr 6 mo	U-1907
8939943	Feb 28, 2031	in 4 yr 6 mo	Product
9022022	Feb 28, 2031	in 4 yr 6 mo	Product
9814838	Feb 28, 2031	in 4 yr 6 mo	Product
10143972	May 24, 2031	in 4 yr 9 mo	U-2476
10143792	May 24, 2031	in 4 yr 9 mo	U-2476
8627816	Feb 04, 2032	in 5 yr 5 mo	Product
12458591	May 11, 2032	in 5 yr 9 mo	U-3671
11020343	May 11, 2032	in 5 yr 9 mo	U-3671
11806428	May 11, 2032	in 5 yr 9 mo	Product
9517307	Jul 18, 2034	in 7 yr 11 mo	ProductU-1925
11617713	Aug 26, 2034	in 8 yr 1 mo	ProductU-3110
11628139	Aug 26, 2034	in 8 yr 1 mo	ProductU-3110
10973814	Aug 26, 2034	in 8 yr 1 mo	ProductU-3110
10722510	Aug 26, 2034	in 8 yr 1 mo	ProductU-3110
11975096	Aug 26, 2034	in 8 yr 1 mo	Product
12414915	Aug 26, 2034	in 8 yr 1 mo	Product
11135155	Aug 26, 2034	in 8 yr 1 mo	Product
10220158	Mar 20, 2035	in 8 yr 7 mo	ProductU-2500
11027072	May 24, 2039	in 12 yr 10 mo	Product
12514854	Feb 05, 2041	in 14 yr 7 mo	U-4397
12622903	Feb 05, 2041	in 14 yr 7 mo	Product
11571518	Jun 14, 2041	in 14 yr 11 mo	ProductU-3515

Approval history

FDA approval span

First approval

Jun 14, 1982

44 yr 11 mo ago

Most recent approval

Aug 18, 2026

1 mo ago

Approvals span 1982–2026 across 87 FDA applications.

Brand (NDA) 1011%

Generic (ANDA) 7789%

Naloxone 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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