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Last Updated: December 13, 2019

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ASTRAMORPH PF Drug Profile

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Which patents cover Astramorph Pf, and when can generic versions of Astramorph Pf launch?

Astramorph Pf is a drug marketed by Fresenius Kabi Usa and is included in four NDAs.

The generic ingredient in ASTRAMORPH PF is morphine sulfate. There are twenty-three drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Astramorph Pf

A generic version of ASTRAMORPH PF was launched as morphine sulfate by HOSPIRA on December 13th, 2019.

Summary for ASTRAMORPH PF
Drug patent expirations by year for ASTRAMORPH PF
Recent Clinical Trials for ASTRAMORPH PF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute on Drug Abuse (NIDA)N/A
Vanderbilt University Medical CenterN/A
National Heart, Lung, and Blood Institute (NHLBI)Phase 4

See all ASTRAMORPH PF clinical trials

Synonyms for ASTRAMORPH PF
(-)-(etorphine)
(-)-Morphine
(-)(5.alpha.,6.alpha.)-7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
(-)Morphine sulfate
(1S,5R,13R,14S,17R)-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7,9,11(18),15-tetraene-10,14-diol
(1S,5R,13R,14S,17R)-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10,15-tetraene-10,14-diol
(1S,5R,13R,14S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol
(4R,4aR,7S,7aR,12bS)-3-methyl-2,4,4a,7,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7,9-diol
(5A,6A)-7,8-DIDEHYDRO-4,5-EPOXY-17-METHYLMORPHINIAN-3,6-DIOL
(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
(5alpha,6alpha)-7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
(5alpha,6alpha)-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
(5alpha,6beta)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
(5R,6S,9R,13S,14R)-4,5-Epoxy-N-methyl-7-morphinen-3,6-diol
(7R,7AS,12BS)-3-METHYL-2,3,4,4A,7,7A-HEXAHYDRO-1H-4,12-METHANO[1]BENZOFURO[3,2-E]ISOQUINOLINE-7,9-DIOL
(Morphine)
(morphine) 4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol
1325730-46-8
17-methyl-7,8-didehydro-4,5alpha-epoxymorphinan-3,6alpha-diol
2-{4-[2,4-diamino-6-pteridinylmethyl(methyl)amino]phenylcarboxamido}pentanedioic acid(morphine)
3-(4-Hydroxy-phenyl)-1-propyl-piperidine-3-carboxylic acid ethyl ester
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol ; HydroChloride
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol ;sulphate salt(morphine)
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol,sulfate(Morphinesulfate)
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol((Morphine))
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol(morphine sulfate)
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol(morphine)
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol(Morphine)(HCl)
4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diolMorphine
4-methyl-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol
4-methyl-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol (morphine)
4-methyl-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol(Morphine)
4,5alpha-Epoxy-17-methyl-7-morphinen-3,6alpha-diol
47106-99-0
57-27-2
6-tert-Butyl-3-methyl-1,2,3,4,5,6-hexahydro-2,6-methano-benzo[d]azocine
6,11-Dimethyl-3-(3-methyl-but-2-enyl)-1,2,3,4,5,6-hexahydro-2,6-methano-benzo[d]azocin-8-ol(Morphine)
6211-15-0 (sulfate (2:1) (salt) pentahydrate)
64-31-3 (sulfate (2:1) (salt) anhydrous)
7,8-Didehydro-4,5-epoxy-17-methyl-morphinan-3,6-diol
7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
7,8-Didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol(morphine)
76I7G6D29C
8053-16-5
85201-37-2
863713-90-0
9H-9,9c-Iminoethanophenanthro(4,5-bcd)furan-3,5-diol, 4a,5,7a,8-tetrahydro-12-methyl-
9H-9,9c-Iminoethanophenanthro(4,5-bcd)furan-3,5-diol, 4alpha,5,7alpha,8-tetrahydro-12-methyl-
Aguettant
AKOS015966554
AN-23579
AN-23737
Avinza
BDBM50000092
BIDD:GT0147
BQJCRHHNABKAKU-KBQPJGBKSA-N
C01516
CCRIS 5762
CHEBI:17303
CHEMBL3978843
CHEMBL70
Cube juice
D-(-)-Morphine
D08233
DB00295
DEA No. 9300
DepoDur
Dimorf
Dinamorf
Dolcontin
Dreamer
DTXSID9023336
Dulcontin
Duramorph
Duramorph PF
Duromorph
EINECS 200-320-2
Epimorph
Epitope ID:116646
GTPL1627
Hard stuff
Hocus
HSDB 2134
Infumorph
Kadian
l-Morphine
LS-91748
M-Eslon
M.O.S
Meconium
methyl[?]diol
MOI
Morfina
Morfina [Italian]
Morfina Dosa (TN)
Morphia
Morphin
Morphin [German]
Morphina
Morphina [Italian]
Morphinan-3,6-alpha-diol, 7,8-didehydro-4,5-alpha-epoxy-17-methyl-
Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl- (5..alpha.,6.alpha.)-
Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl- (5alpha,6alpha)-
Morphinan-3,6-diol, 7,8-didehydro-4,5-epoxy-17-methyl-, (5alpha,6alpha)-
morphine
Morphine (BAN)
Morphine [BAN]
Morphine 0.1 mg/ml in Methanol
Morphine 1.0 mg/ml in Methanol
Morphine Anhydrate
Morphine Extra-Forte
Morphine Forte
Morphine H.P
Morphine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
MORPHINE SULFATE
MORPHINE, (5A,6A)-7,8-DIDEHYDRO-4,5-EPOXY-17-METHYLMORPHINIAN-3,6-DIOL, MORPHIUM, MORPHIA, DOLCONTIN, DUROMORPH, MORPHINA, NEPENTHE
Morphine;4-methyl-(1S,5R,13R,14S,17R)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10,15-tetraene-10,14-diol
Morphinism
Morphinum
Morphitec
Morphium
Morpho
Moscontin
MS Contin
Ms Emma
MS/L
MS/S
Mscontin, Oramorph
MSIR
Nepenthe
NSC11441
OMS Concentrate
Oramorph
Oramorph SR
Ospalivina
Rescudose
RMS
RMS Uniserts
Roxanol
Roxanol 100
Roxanol UD
SCHEMBL2997
SDZ 202-250
SDZ202-250
Sevredol
Statex Drops
Statex SR
Substitol (TN)
UNII-1M5VY6ITRT component BQJCRHHNABKAKU-KBQPJGBKSA-N
UNII-76I7G6D29C
Unkie
ZINC3812983

US Patents and Regulatory Information for ASTRAMORPH PF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071050-001 Oct 7, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071053-001 Oct 7, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071051-001 Oct 7, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071052-001 Oct 7, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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