Is there a generic for Diazepam?

Yes. The FDA Orange Book lists 88 approved generic (ANDA) applications for Diazepam, referencing the brand VALTOCO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diazepam?

VALTOCO (NDA 211635, NEURELIS INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Diazepam?

The Orange Book lists 8 patents against Diazepam 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 Diazepam have FDA marketing exclusivity?

Yes. The Orange Book records 6 marketing-exclusivity periods for Diazepam. 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 Diazepam are approved?

Diazepam is approved in the following dosage forms: capsule, extended release, concentrate, gel, injectable, solution, spray, tablet.

FDA Orange Book · active-ingredient family

Diazepam

Diazepam: 7 brands, 88 generics; first approved Sep 04, 1985; generic available.

Generic available6 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 88 ANDA applications approved.

Earliest patent expiry Mar 27, 2029Latest exclusivity ends Apr 15, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 27, 2029

in 2 yr 7 mo

Brand (NDA) products

Originator applications

VALTOCORLD
NEURELIS INCNDA 21163520203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/SPRAY SPRAY NASAL Rx —
7.5MG/SPRAY SPRAY NASAL Rx —
10MG/SPRAY SPRAY NASAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/SPRAY	SPRAY	NASAL	Rx	—
7.5MG/SPRAY	SPRAY	NASAL	Rx	—
10MG/SPRAY	SPRAY	NASAL	Rx	—

DIASTATRLDRS

BAUSCHNDA 02064819977 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG/0.5ML (5MG/ML)	GEL	RECTAL	Rx	AB
5MG/ML (5MG/ML)	GEL	RECTAL	Discontinued	—
10MG/2ML (5MG/ML)	GEL	RECTAL	Discontinued	—
15MG/3ML (5MG/ML)	GEL	RECTAL	Discontinued	—
20MG/4ML (5MG/ML)	GEL	RECTAL	Discontinued	—
20MG/4ML (5MG/ML)	GEL	RECTAL	Rx	AB
10MG/2ML (5MG/ML)	GEL	RECTAL	Rx	AB

VALIUMRLD
ROCHENDA 016087—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
VALIUMRLD
WAYLIS THERAPNDA 013263—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DIZAC
PHARMACIA AND UPJOHNNDA 0192871993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
US ARMYNDA 0201241990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
VALRELEASE
ROCHENDA 018179—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
15MG CAPSULE, EXTENDED RELEASE ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

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

Generic (ANDA) products (88)

Abbreviated applications

DIAZEPAM
BAXTER HLTHCARE CORPANDA 21988220262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
20MG/4ML (5MG/ML) INJECTABLE INJECTION Rx —
DIAZEPAM
LUPINANDA 2203652026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
NAVINTA LLCANDA 21746820253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG/0.5ML (5MG/ML) GEL RECTAL Rx AB
10MG/2ML (5MG/ML) GEL RECTAL Rx AB
20MG/4ML (5MG/ML) GEL RECTAL Rx AB
DIAZEPAM
GALENICUM HLTHANDA 2164222025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/10ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
LONG GROVE PHARMSANDA 2171782024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
NUVO PHARMANDA 07046420243 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
DIAZEPAM
DR REDDYSANDA 2184222024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
ALEMBICANDA 2184502024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
AUROBINDO PHARMA LTDANDA 21784320233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
DIAZEPAM
NOVEL LABS INCANDA 09107620232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) GEL RECTAL Rx AB
20MG/4ML (5MG/ML) GEL RECTAL Rx AB
DIAZEPAM
FRESENIUS KABI USAANDA 2147452022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
REGCON HOLDINGSANDA 2119982019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/10ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAMRS
REGCON HOLDINGSANDA 2103632019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
CHARTWELL MOLECULARANDA 2064772016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
DIAZEPAM
CHARTWELL MOLECULARANDA 2044332014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML CONCENTRATE ORAL Rx AA
DIAZEPAM
STRIDES PHARMA INTLANDA 07774920063 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
10MG TABLET ORAL Discontinued —
DIAZEPAM
PARENTA PHARMSANDA 0768152004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
MARSAM PHARMS LLCANDA 0723711993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
WATSON LABS INCANDA 0723701993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
WATSON LABS INCANDA 0723971993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
MARTEC USA LLCANDA 0724021989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
HOSPIRAANDA 0720791988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
PIONEER PHARMSANDA 0707871988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
PIONEER PHARMSANDA 0707881988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
PIONEER PHARMSANDA 0707761988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
Q-PAM
QUANTUM PHARMICSANDA 0724311988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
Q-PAM
QUANTUM PHARMICSANDA 0724321988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
Q-PAM
QUANTUM PHARMICSANDA 0724331988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
WARNER CHILCOTTANDA 0716131987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
WARNER CHILCOTTANDA 0716141987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
HOSPIRAANDA 0715841987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAMRS
HOSPIRAANDA 0715831987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/10ML (5MG/ML) INJECTABLE INJECTION Rx AP
DIAZEPAM
HIKMAANDA 0713081987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
HIKMAANDA 0713091987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
HIKMAANDA 0713101987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM INTENSOLRS
HIKMAANDA 0714151987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML CONCENTRATE ORAL Rx AA
DIAZEPAMRS
HIKMAANDA 0709281987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
DIAZEPAM
FERNDALE LABSANDA 0709031987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
FERNDALE LABSANDA 0709041987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
FERNDALE LABSANDA 0709051987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
DR REDDYS LABS SAANDA 0711341987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
DIAZEPAM
DR REDDYS LABS SAANDA 0711351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
DIAZEPAM
DR REDDYS LABS SAANDA 0711361987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0713071986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0713211986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0713221986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
DIAZEPAM
WATSON LABSANDA 0709301986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
WATSON LABSANDA 0709111986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
WATSON LABSANDA 0709121986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
DURAMED PHARMS BARRANDA 0708941986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
DURAMED PHARMS BARRANDA 0708951986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
DURAMED PHARMS BARRANDA 0708961986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
HALSEYANDA 0709871986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
HALSEYANDA 0709961986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
HALSEYANDA 0709561986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
ABRAXIS PHARMANDA 0706621986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
ROXANEANDA 0703561986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
ROXANEANDA 0703571986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
ROXANEANDA 0703581986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
ACTAVIS ELIZABETHANDA 0707811986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
ACTAVIS ELIZABETHANDA 0707061986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
ACTAVIS ELIZABETHANDA 0707071986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
VIRTUSANDA 0704621986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
VIRTUSANDA 0704631986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
WATSON LABSANDA 0702961986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
CHARTWELL RXANDA 0703021985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
CHARTWELL RXANDA 0703031985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
CHARTWELL RXANDA 0703041985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP
20MG/4ML (5MG/ML)	INJECTABLE	INJECTION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	GEL	RECTAL	Rx	AB
20MG/4ML (5MG/ML)	GEL	RECTAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	CONCENTRATE	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	CONCENTRATE	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

DIAZEPAM

HIKMAANDA 07031119853 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/10ML (5MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/ML (5MG/ML)	INJECTABLE	INJECTION	Discontinued	—
10MG/2ML (5MG/ML)	INJECTABLE	INJECTION	Discontinued	—

DIAZEPAM
HIKMAANDA 0703121985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML INJECTABLE INJECTION Discontinued —
DIAZEPAM
HIKMAANDA 0703131985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/2ML (5MG/ML) INJECTABLE INJECTION Rx AP
Q-PAM
QUANTUM PHARMICSANDA 0704231985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
Q-PAM
QUANTUM PHARMICSANDA 0704241985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
Q-PAM
QUANTUM PHARMICSANDA 0704251985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
BARRANDA 0701521985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
BARRANDA 0701541985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
TEVA PHARMSANDA 0701531985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
WATSON LABSANDA 0704561985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
WATSON LABSANDA 0704571985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
WATSON LABSANDA 0704581985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
PH HEALTHANDA 07022819853 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
5MG TABLET ORAL Discontinued —
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0703601985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0703611985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
IVAX SUB TEVA PHARMSANDA 0703621985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —
DIAZEPAM
MYLANANDA 07032519853 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
5MG TABLET ORAL Rx AB
DIAZEPAM
WARNER CHILCOTTANDA 0702091985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
DIAZEPAM
WARNER CHILCOTTANDA 0702101985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued —
DIAZEPAM
WARNER CHILCOTTANDA 0702221985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued —

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 7 mo
ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 4 mo
NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 7 mo
ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 4 mo
NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 7 mo
ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 4 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
12521400	Mar 27, 2029	in 2 yr 7 mo	Product
11793786	Mar 27, 2029	in 2 yr 7 mo	Product
12268664	Mar 27, 2029	in 2 yr 7 mo	Product
8895546	Mar 27, 2029	in 2 yr 7 mo	Product
11241414	Mar 27, 2029	in 2 yr 7 mo	Product
12337061	Jun 13, 2032	in 5 yr 10 mo	U-4173
12324852	Oct 16, 2032	in 6 yr 2 mo	U-4173
12599611	Jun 10, 2042	in 16 yr	U-4455

Approval history

FDA approval span

First approval

Sep 04, 1985

41 yr 8 mo ago

Most recent approval

Jul 28, 2026

2 mo ago

Approvals span 1985–2026 across 95 FDA applications.

Brand (NDA) 77%

Generic (ANDA) 8893%

Diazepam: 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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