FDA Orange Book · active-ingredient family
Diazepam
Diazepam: 7 brands, 86 generics; first approved Sep 04, 1985; generic available.
Generic available6 exclusivity periodsHas discontinued products
Generic status & protection
Generic available — 86 ANDA applications approved.
Earliest patent expiry Mar 27, 2029Latest exclusivity ends Apr 15, 2028
Brands (NDA)
7
Generics (ANDA)
86
Listed patents
8
Next patent expiry
Mar 27, 2029
in 2 yr 9 mo
Originator applications
Brand (NDA) products
VALTOCORLDNEURELIS INCNDA 21163520203 strengths
VALTOCORLD
NEURELIS INCNDA 21163520203 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/SPRAY | SPRAY | NASAL | Rx | — |
| 7.5MG/SPRAY | SPRAY | NASAL | Rx | — |
| 10MG/SPRAY | SPRAY | NASAL | Rx | — |
BAUSCHNDA 02064819977 strengths
BAUSCHNDA 02064819977 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2.5MG/0.5ML (5MG/ML) | GEL | RECTAL | Rx | AB |
| 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | RECTAL | Discontinued | — |
| 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | RECTAL | Discontinued | — |
| 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | RECTAL | Discontinued | — |
| 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | RECTAL | Discontinued | — |
| 20MG/4ML (5MG/ML) | GEL | RECTAL | Rx | AB |
| 10MG/2ML (5MG/ML) | GEL | RECTAL | Rx | AB |
VALIUMRLDROCHENDA 016087—
VALIUMRLD
ROCHENDA 016087—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
VALIUMRLDWAYLIS THERAPNDA 013263—3 strengths
VALIUMRLD
WAYLIS THERAPNDA 013263—3 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 5MG | TABLET | ORAL | Rx | AB |
| 10MG | TABLET | ORAL | Rx | AB |
PHARMACIA AND UPJOHNNDA 0192871993
PHARMACIA AND UPJOHNNDA 0192871993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
US ARMYNDA 0201241990
US ARMYNDA 0201241990
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | INJECTION | Discontinued | — |
ROCHENDA 018179—
ROCHENDA 018179—
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 15MG | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
Abbreviated applications
Generic (ANDA) products (86)
NAVINTA LLCANDA 21746820253 strengths
NAVINTA LLCANDA 21746820253 strengths
| 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 |
GALENICUM HLTHANDA 2164222025
GALENICUM HLTHANDA 2164222025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 50MG/10ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
LONG GROVE PHARMSANDA 2171782024
LONG GROVE PHARMSANDA 2171782024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
NUVO PHARMANDA 07046420243 strengths
NUVO PHARMANDA 07046420243 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Rx | AB |
| 2MG | TABLET | ORAL | Rx | AB |
| 5MG | TABLET | ORAL | Rx | AB |
DR REDDYSANDA 2184222024
DR REDDYSANDA 2184222024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
ALEMBICANDA 2184502024
ALEMBICANDA 2184502024
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
AUROBINDO PHARMA LTDANDA 21784320233 strengths
AUROBINDO PHARMA LTDANDA 21784320233 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
| 5MG | TABLET | ORAL | Rx | AB |
| 10MG | TABLET | ORAL | Rx | AB |
NOVEL LABS INCANDA 09107620232 strengths
NOVEL LABS INCANDA 09107620232 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | GEL | RECTAL | Rx | AB |
| 20MG/4ML (5MG/ML) | GEL | RECTAL | Rx | AB |
FRESENIUS KABI USAANDA 2147452022
FRESENIUS KABI USAANDA 2147452022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
REGCON HOLDINGSANDA 2119982019
REGCON HOLDINGSANDA 2119982019
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 50MG/10ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
DIAZEPAMRSREGCON HOLDINGSANDA 2103632019
DIAZEPAMRS
REGCON HOLDINGSANDA 2103632019
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
CHARTWELL MOLECULARANDA 2064772016
CHARTWELL MOLECULARANDA 2064772016
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/5ML | SOLUTION | ORAL | Rx | AA |
CHARTWELL MOLECULARANDA 2044332014
CHARTWELL MOLECULARANDA 2044332014
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | CONCENTRATE | ORAL | Rx | AA |
STRIDES PHARMA INTLANDA 07774920063 strengths
STRIDES PHARMA INTLANDA 07774920063 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
| 5MG | TABLET | ORAL | Discontinued | — |
| 10MG | TABLET | ORAL | Discontinued | — |
PARENTA PHARMSANDA 0768152004
PARENTA PHARMSANDA 0768152004
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
MARSAM PHARMS LLCANDA 0723711993
MARSAM PHARMS LLCANDA 0723711993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABS INCANDA 0723701993
WATSON LABS INCANDA 0723701993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABS INCANDA 0723971993
WATSON LABS INCANDA 0723971993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
MARTEC USA LLCANDA 0724021989
MARTEC USA LLCANDA 0724021989
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
HOSPIRAANDA 0720791988
HOSPIRAANDA 0720791988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
PIONEER PHARMSANDA 0707871988
PIONEER PHARMSANDA 0707871988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
PIONEER PHARMSANDA 0707881988
PIONEER PHARMSANDA 0707881988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
PIONEER PHARMSANDA 0707761988
PIONEER PHARMSANDA 0707761988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
QUANTUM PHARMICSANDA 0724311988
QUANTUM PHARMICSANDA 0724311988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
QUANTUM PHARMICSANDA 0724321988
QUANTUM PHARMICSANDA 0724321988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
QUANTUM PHARMICSANDA 0724331988
QUANTUM PHARMICSANDA 0724331988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
WARNER CHILCOTTANDA 0716131987
WARNER CHILCOTTANDA 0716131987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WARNER CHILCOTTANDA 0716141987
WARNER CHILCOTTANDA 0716141987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HOSPIRAANDA 0715841987
HOSPIRAANDA 0715841987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
DIAZEPAMRSHOSPIRAANDA 0715831987
DIAZEPAMRS
HOSPIRAANDA 0715831987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 50MG/10ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
HIKMAANDA 0713081987
HIKMAANDA 0713081987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0713091987
HIKMAANDA 0713091987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0713101987
HIKMAANDA 0713101987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0714151987
HIKMAANDA 0714151987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | CONCENTRATE | ORAL | Rx | AA |
DIAZEPAMRSHIKMAANDA 0709281987
DIAZEPAMRS
HIKMAANDA 0709281987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/5ML | SOLUTION | ORAL | Rx | AA |
FERNDALE LABSANDA 0709031987
FERNDALE LABSANDA 0709031987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
FERNDALE LABSANDA 0709041987
FERNDALE LABSANDA 0709041987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
FERNDALE LABSANDA 0709051987
FERNDALE LABSANDA 0709051987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
DR REDDYS LABS SAANDA 0711341987
DR REDDYS LABS SAANDA 0711341987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
DR REDDYS LABS SAANDA 0711351987
DR REDDYS LABS SAANDA 0711351987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Rx | AB |
DR REDDYS LABS SAANDA 0711361987
DR REDDYS LABS SAANDA 0711361987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Rx | AB |
IVAX SUB TEVA PHARMSANDA 0713071986
IVAX SUB TEVA PHARMSANDA 0713071986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Rx | AB |
IVAX SUB TEVA PHARMSANDA 0713211986
IVAX SUB TEVA PHARMSANDA 0713211986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Rx | AB |
IVAX SUB TEVA PHARMSANDA 0713221986
IVAX SUB TEVA PHARMSANDA 0713221986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Rx | AB |
WATSON LABSANDA 0709301986
WATSON LABSANDA 0709301986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABSANDA 0709111986
WATSON LABSANDA 0709111986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
WATSON LABSANDA 0709121986
WATSON LABSANDA 0709121986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
DURAMED PHARMS BARRANDA 0708941986
DURAMED PHARMS BARRANDA 0708941986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
DURAMED PHARMS BARRANDA 0708951986
DURAMED PHARMS BARRANDA 0708951986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
DURAMED PHARMS BARRANDA 0708961986
DURAMED PHARMS BARRANDA 0708961986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
HALSEYANDA 0709871986
HALSEYANDA 0709871986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
HALSEYANDA 0709961986
HALSEYANDA 0709961986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
HALSEYANDA 0709561986
HALSEYANDA 0709561986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
ABRAXIS PHARMANDA 0706621986
ABRAXIS PHARMANDA 0706621986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
ROXANEANDA 0703561986
ROXANEANDA 0703561986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
ROXANEANDA 0703571986
ROXANEANDA 0703571986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
ROXANEANDA 0703581986
ROXANEANDA 0703581986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
ACTAVIS ELIZABETHANDA 0707811986
ACTAVIS ELIZABETHANDA 0707811986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
ACTAVIS ELIZABETHANDA 0707061986
ACTAVIS ELIZABETHANDA 0707061986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
ACTAVIS ELIZABETHANDA 0707071986
ACTAVIS ELIZABETHANDA 0707071986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
VIRTUSANDA 0704621986
VIRTUSANDA 0704621986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
VIRTUSANDA 0704631986
VIRTUSANDA 0704631986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0702961986
WATSON LABSANDA 0702961986
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
CHARTWELL RXANDA 0703021985
CHARTWELL RXANDA 0703021985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
CHARTWELL RXANDA 0703031985
CHARTWELL RXANDA 0703031985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
CHARTWELL RXANDA 0703041985
CHARTWELL RXANDA 0703041985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
HIKMAANDA 07031119853 strengths
HIKMAANDA 07031119853 strengths
| 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 | — |
HIKMAANDA 0703121985
HIKMAANDA 0703121985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG/ML | INJECTABLE | INJECTION | Discontinued | — |
HIKMAANDA 0703131985
HIKMAANDA 0703131985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG/2ML (5MG/ML) | INJECTABLE | INJECTION | Rx | AP |
QUANTUM PHARMICSANDA 0704231985
QUANTUM PHARMICSANDA 0704231985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
QUANTUM PHARMICSANDA 0704241985
QUANTUM PHARMICSANDA 0704241985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
QUANTUM PHARMICSANDA 0704251985
QUANTUM PHARMICSANDA 0704251985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
BARRANDA 0701521985
BARRANDA 0701521985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
BARRANDA 0701541985
BARRANDA 0701541985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
TEVA PHARMSANDA 0701531985
TEVA PHARMSANDA 0701531985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0704561985
WATSON LABSANDA 0704561985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0704571985
WATSON LABSANDA 0704571985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
WATSON LABSANDA 0704581985
WATSON LABSANDA 0704581985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
PH HEALTHANDA 07022819853 strengths
PH HEALTHANDA 07022819853 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
| 2MG | TABLET | ORAL | Discontinued | — |
| 5MG | TABLET | ORAL | Discontinued | — |
IVAX SUB TEVA PHARMSANDA 0703601985
IVAX SUB TEVA PHARMSANDA 0703601985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
IVAX SUB TEVA PHARMSANDA 0703611985
IVAX SUB TEVA PHARMSANDA 0703611985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
IVAX SUB TEVA PHARMSANDA 0703621985
IVAX SUB TEVA PHARMSANDA 0703621985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
MYLANANDA 07032519853 strengths
MYLANANDA 07032519853 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Rx | AB |
| 2MG | TABLET | ORAL | Rx | AB |
| 5MG | TABLET | ORAL | Rx | AB |
WARNER CHILCOTTANDA 0702091985
WARNER CHILCOTTANDA 0702091985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2MG | TABLET | ORAL | Discontinued | — |
WARNER CHILCOTTANDA 0702101985
WARNER CHILCOTTANDA 0702101985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 5MG | TABLET | ORAL | Discontinued | — |
WARNER CHILCOTTANDA 0702221985
WARNER CHILCOTTANDA 0702221985
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 10MG | TABLET | ORAL | Discontinued | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (6)
- NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 9 mo
- ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 6 mo
- NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 9 mo
- ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 6 mo
- NPPNew patient population exclusivity (3 years)
Apr 15, 2028
in 1 yr 9 mo
- ODE-279Orphan-drug exclusivity (7 years)
Jan 10, 2027
in 6 mo
Orange Book patent file
Listed patents
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12521400 | Mar 27, 2029 | in 2 yr 9 mo | Product |
| 11793786 | Mar 27, 2029 | in 2 yr 9 mo | Product |
| 12268664 | Mar 27, 2029 | in 2 yr 9 mo | Product |
| 8895546 | Mar 27, 2029 | in 2 yr 9 mo | Product |
| 11241414 | Mar 27, 2029 | in 2 yr 9 mo | Product |
| 12337061 | Jun 13, 2032 | in 6 yr | U-4173 |
| 12324852 | Oct 16, 2032 | in 6 yr 4 mo | U-4173 |
| 12599611 | Jun 10, 2042 | in 16 yr 2 mo | U-4455 |
FDA approval span
Approval history
First approval
Sep 04, 1985
41 yr 5 mo ago
Most recent approval
Nov 14, 2025
8 mo ago
Approvals span 1985–2025 across 93 FDA applications.
Brand (NDA) 78%
Generic (ANDA) 8692%
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.
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.
