FDA Orange Book · active-ingredient family
Naloxone hydrochloride
Naloxone hydrochloride: 10 brands, 76 generics; first approved Jun 14, 1982; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available — 76 ANDA applications approved.
Earliest patent expiry Feb 01, 2026Latest exclusivity ends Apr 19, 2027
Brands (NDA)
10
Generics (ANDA)
76
Listed patents
37
Next patent expiry
Feb 01, 2026
5 mo ago
Originator applications
Brand (NDA) products
KLOXXADORLDHIKMANDA 21204520252 strengths
KLOXXADORLD
HIKMANDA 21204520252 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 8MG/SPRAY | SPRAY | NASAL | Rx | — |
| 4MG/SPRAY | SPRAY | NASAL | Rx | — |
SCIENTURENDA 2154872024
SCIENTURENDA 2154872024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/SPRAY | SPRAY | NASAL | Rx | — |
HARM REDUCTION THERPNDA 2177222023
HARM REDUCTION THERPNDA 2177222023
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 3MG/SPRAY | SPRAY, METERED | NASAL | OTC | — |
AMPHASTAR PHARMS INCNDA 2089692023
AMPHASTAR PHARMS INCNDA 2089692023
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | NASAL | Rx | — |
KALEO INCNDA 2154572022
KALEO INCNDA 2154572022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/0.4ML (10MG/0.4ML) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | Discontinued | — |
ZMI PHARMANDA 2128542021
ZMI PHARMANDA 2128542021
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/0.5ML (5MG/0.5ML) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | Rx | — |
NARCANRLDEMERGENTNDA 20841120172 strengths
NARCANRLD
EMERGENTNDA 20841120172 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | NASAL | OTC | — |
| 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED | NASAL | Discontinued | — |
KALEO INCNDA 2098622016
KALEO INCNDA 2098622016
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG/0.4ML (2MG/0.4ML) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | Discontinued | — |
EVZIORLDKALEO INCNDA 2057872014
EVZIORLD
KALEO INCNDA 2057872014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/0.4ML (0.4MG/0.4ML) | SOLUTION | INTRAMUSCULAR, SUBCUTANEOUS | Discontinued | — |
NARCANRLDADAPTNDA 016636—3 strengths
NARCANRLD
ADAPTNDA 016636—3 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
| 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
| 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (76)
STERINOVA INCANDA 2142112025
STERINOVA INCANDA 2142112025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
PADAGIS ISRAELANDA 2167192025
PADAGIS ISRAELANDA 2167192025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 8MG/SPRAY | SPRAY | NASAL | Discontinued | — |
AMNEALANDA 2179922024
AMNEALANDA 2179922024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | NASAL | OTC | — |
FRESENIUS KABI USAANDA 21357320242 strengths
FRESENIUS KABI USAANDA 21357320242 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
HIKMAANDA 21230020242 strengths
HIKMAANDA 21230020242 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
MANKIND PHARMAANDA 2184042024
MANKIND PHARMAANDA 2184042024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
BPI LABSANDA 2169772023
BPI LABSANDA 2169772023
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
BAXTER HLTHCARE CORPANDA 2147922022
BAXTER HLTHCARE CORPANDA 2147922022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
ACCORD HLTHCAREANDA 21662420222 strengths
ACCORD HLTHCAREANDA 21662420222 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
PH HEALTHANDA 2159642022
PH HEALTHANDA 2159642022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
PADAGIS ISRAELANDA 2119512022
PADAGIS ISRAELANDA 2119512022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | NASAL | OTC | — |
MYLAN LABS LTDANDA 2138432022
MYLAN LABS LTDANDA 2138432022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
BAXTER HLTHCARE CORPANDA 21478520212 strengths
BAXTER HLTHCARE CORPANDA 21478520212 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
EUGIA PHARMAANDA 2132792021
EUGIA PHARMAANDA 2132792021
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
DR REDDYSANDA 2132092020
DR REDDYSANDA 2132092020
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
PH HEALTHANDA 2112862020
PH HEALTHANDA 2112862020
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
EUGIA PHARMAANDA 2124562019
EUGIA PHARMAANDA 2124562019
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
EUGIA PHARMAANDA 2124552019
EUGIA PHARMAANDA 2124552019
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
TEVA PHARMS USAANDA 2095222019
TEVA PHARMS USAANDA 2095222019
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 4MG/SPRAY | SPRAY, METERED | NASAL | OTC | — |
CHARTWELL RXANDA 2078462018
CHARTWELL RXANDA 2078462018
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SOMERSET THERAPS LLCANDA 2076332017
SOMERSET THERAPS LLCANDA 2076332017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
SOMERSET THERAPS LLCANDA 2076342017
SOMERSET THERAPS LLCANDA 2076342017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
RISINGANDA 2088722017
RISINGANDA 2088722017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
RISINGANDA 2088712017
RISINGANDA 2088712017
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
MYLAN INSTITUTIONALANDA 2050142016
MYLAN INSTITUTIONALANDA 2050142016
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
MYLAN INSTITUTIONALANDA 2049972014
MYLAN INSTITUTIONALANDA 2049972014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
ASTRAZENECAANDA 0720811989
ASTRAZENECAANDA 0720811989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720821989
IGI LABS INCANDA 0720821989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720831989
IGI LABS INCANDA 0720831989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720841989
IGI LABS INCANDA 0720841989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720851989
IGI LABS INCANDA 0720851989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720861989
IGI LABS INCANDA 0720861989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720871989
IGI LABS INCANDA 0720871989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720881989
IGI LABS INCANDA 0720881989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720891989
IGI LABS INCANDA 0720891989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720901989
IGI LABS INCANDA 0720901989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720911989
IGI LABS INCANDA 0720911989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720921989
IGI LABS INCANDA 0720921989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
IGI LABS INCANDA 0720931989
IGI LABS INCANDA 0720931989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
ABRAXIS PHARMANDA 0716041988
ABRAXIS PHARMANDA 0716041988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
BRISTOL MYERS SQUIBBANDA 0710831988
BRISTOL MYERS SQUIBBANDA 0710831988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
BRISTOL MYERS SQUIBBANDA 0710841988
BRISTOL MYERS SQUIBBANDA 0710841988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
BRISTOL MYERS SQUIBBANDA 0713111988
BRISTOL MYERS SQUIBBANDA 0713111988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
MARSAM PHARMS LLCANDA 0718111988
MARSAM PHARMS LLCANDA 0718111988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0712721988
HIKMAANDA 0712721988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0712731988
HIKMAANDA 0712731988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0712741988
HIKMAANDA 0712741988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0712871988
HIKMAANDA 0712871988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
INTL MEDICATIONANDA 0721151988
INTL MEDICATIONANDA 0721151988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Discontinued | — |
INTL MEDICATIONANDA 0720761988
INTL MEDICATIONANDA 0720761988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 1MG/ML | INJECTABLE | INJECTION | Rx | AP |
WATSON LABSANDA 0713391987
WATSON LABSANDA 0713391987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SMITH AND NEPHEWANDA 0716711987
SMITH AND NEPHEWANDA 0716711987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SMITH AND NEPHEWANDA 0716811987
SMITH AND NEPHEWANDA 0716811987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SMITH AND NEPHEWANDA 0716821987
SMITH AND NEPHEWANDA 0716821987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SOLOPAKANDA 0716721987
SOLOPAKANDA 0716721987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
SOLOPAKANDA 0716831987
SOLOPAKANDA 0716831987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0702521987
HOSPIRAANDA 0702521987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0702531987
HOSPIRAANDA 0702531987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0702541987
HOSPIRAANDA 0702541987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0702551987
HOSPIRAANDA 0702551987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0702561987
HOSPIRAANDA 0702561987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
HOSPIRAANDA 0702571987
HOSPIRAANDA 0702571987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
ABRAXIS PHARMANDA 0706481986
ABRAXIS PHARMANDA 0706481986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
ABRAXIS PHARMANDA 0706611986
ABRAXIS PHARMANDA 0706611986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
ABRAXIS PHARMANDA 0706491986
ABRAXIS PHARMANDA 0706491986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0702981986
HIKMAANDA 0702981986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0702991986
HIKMAANDA 0702991986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
HIKMAANDA 0704961986
HIKMAANDA 0704961986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WYETH AYERSTANDA 0701881986
WYETH AYERSTANDA 0701881986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WYETH AYERSTANDA 0701891986
WYETH AYERSTANDA 0701891986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WYETH AYERSTANDA 0701901986
WYETH AYERSTANDA 0701901986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WYETH AYERSTANDA 0701911986
WYETH AYERSTANDA 0701911986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0701711986
HOSPIRAANDA 0701711986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.02MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0701721986
HOSPIRAANDA 0701721986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Rx | AP |
INTL MEDICATIONANDA 0704171986
INTL MEDICATIONANDA 0704171986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
INTL MEDICATIONANDA 0706391986
INTL MEDICATIONANDA 0706391986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 0.4MG/ML | INJECTABLE | INJECTION | Discontinued | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Mar 07, 2026
4 mo ago
- NPNew product exclusivity (3 years)
Apr 19, 2027
in 9 mo
Orange Book patent file
Listed patents
Listed patents (37)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9278182 | Feb 01, 2026 | 5 mo ago | Product |
| 8926594 | Mar 31, 2026 | 3 mo ago | Product |
| 7731686 | Jun 10, 2026 | 1 mo ago | Product |
| 10960155 | Jun 25, 2026 | 16 d ago | Product |
| 11590286 | Dec 12, 2026 | in 5 mo | Product |
| 9238108 | Feb 20, 2027 | in 7 mo | Product |
| 8206360 | Feb 27, 2027 | in 8 mo | Product |
| 9724471 | May 23, 2027 | in 11 mo | ProductU-2092 |
| 7947017 | Mar 12, 2028 | in 1 yr 8 mo | Product |
| 7749194 | Oct 30, 2028 | in 2 yr 4 mo | Product |
| 8231573 | Nov 25, 2028 | in 2 yr 5 mo | Product |
| 8226610 | Apr 10, 2029 | in 2 yr 9 mo | Product |
| 8021344 | Nov 02, 2029 | in 3 yr 4 mo | Product |
| 9474869 | Feb 28, 2031 | in 4 yr 8 mo | ProductU-1907 |
| 10322239 | Feb 28, 2031 | in 4 yr 8 mo | U-1907 |
| 8939943 | Feb 28, 2031 | in 4 yr 8 mo | Product |
| 9022022 | Feb 28, 2031 | in 4 yr 8 mo | Product |
| 9814838 | Feb 28, 2031 | in 4 yr 8 mo | Product |
| 10143972 | May 24, 2031 | in 4 yr 11 mo | U-2476 |
| 10143792 | May 24, 2031 | in 4 yr 11 mo | U-2476 |
| 8627816 | Feb 04, 2032 | in 5 yr 8 mo | Product |
| 12458591 | May 11, 2032 | in 5 yr 11 mo | U-3671 |
| 11020343 | May 11, 2032 | in 5 yr 11 mo | U-3671 |
| 11806428 | May 11, 2032 | in 5 yr 11 mo | Product |
| 9517307 | Jul 18, 2034 | in 8 yr 2 mo | ProductU-1925 |
| 11617713 | Aug 26, 2034 | in 8 yr 3 mo | ProductU-3110 |
| 11628139 | Aug 26, 2034 | in 8 yr 3 mo | ProductU-3110 |
| 10973814 | Aug 26, 2034 | in 8 yr 3 mo | ProductU-3110 |
| 10722510 | Aug 26, 2034 | in 8 yr 3 mo | ProductU-3110 |
| 11975096 | Aug 26, 2034 | in 8 yr 3 mo | Product |
| 12414915 | Aug 26, 2034 | in 8 yr 3 mo | Product |
| 11135155 | Aug 26, 2034 | in 8 yr 3 mo | Product |
| 10220158 | Mar 20, 2035 | in 8 yr 10 mo | ProductU-2500 |
| 11027072 | May 24, 2039 | in 13 yr 1 mo | Product |
| 12514854 | Feb 05, 2041 | in 14 yr 9 mo | U-4397 |
| 12622903 | Feb 05, 2041 | in 14 yr 9 mo | Product |
| 11571518 | Jun 14, 2041 | in 15 yr 2 mo | ProductU-3515 |
FDA approval span
Approval history
First approval
Jun 14, 1982
44 yr 9 mo ago
Most recent approval
Aug 25, 2025
11 mo ago
Approvals span 1982–2025 across 86 FDA applications.
Brand (NDA) 1012%
Generic (ANDA) 7688%
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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
