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Generated: May 22, 2018

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Morphine sulfate - Generic Drug Details

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What are the generic sources for morphine sulfate and what is the scope of morphine sulfate freedom to operate?

Morphine sulfate
is the generic ingredient in twelve branded drugs marketed by King Pharms Llc, Allergan Sales Llc, Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher-smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, West-ward Pharms Int, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Ani Pharms Inc, Hi-tech Pharmacal, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, Vistapharm, Egalet, Daiichi Sankyo Inc, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Purdue Pharma Lp, Xanodyne Pharms Inc, and Alpharma Pharms, and is included in sixty-seven NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has forty-seven patent family members in twelve countries.

There are twenty-three drug master file entries for morphine sulfate. Fifty-four suppliers are listed for this compound.
Pharmacology for morphine sulfate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for morphine sulfate
Synonyms for morphine sulfate
(-)-(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
(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
(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
Astramorph PF
Avinza
BDBM50000092
BIDD:GT0147
BQJCRHHNABKAKU-KBQPJGBKSA-N
C01516
CCRIS 5762
CHEBI:17303
CHEMBL70
Cube juice
D-(-)-Morphine
D08233
D0WE3O
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?,6?)-
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 liposomal
Morphine sulfate hydrate
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-76I7G6D29C
Unkie
ZINC3812983

US Patents and Regulatory Information for morphine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 074862-003 Jul 7, 1998 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 074862-001 Jul 7, 1998 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-004 Oct 2, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int INFUMORPH morphine sulfate INJECTABLE;INJECTION 018565-004 Jul 19, 1991 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for morphine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ➤ Sign Up ➤ Sign Up
Purdue Pharma Lp MS CONTIN morphine sulfate TABLET, EXTENDED RELEASE;ORAL 019516-001 May 29, 1987 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004 ➤ Sign Up ➤ Sign Up
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-001 May 18, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for morphine sulfate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Sign Up
2,017,333,354 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Dow
Cantor Fitzgerald
US Department of Justice
Deloitte
Farmers Insurance
McKinsey
Federal Trade Commission
Covington

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