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Last Updated: April 6, 2020

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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 freedom to operate?

Morphine sulfate is the generic ingredient in thirteen branded drugs marketed by King Pharms Llc, Allergan, Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Pacira Pharms Inc, Fresenius Kabi Usa, West-ward Pharms Int, Piramal Critical, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Ani Pharms Inc, Hi Tech, Hikma, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Zyla, 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, Vintage Pharms Llc, Purdue Pharma Lp, Xanodyne Pharms Inc, and Alpharma Pharms, and is included in sixty-eight NDAs. There are sixteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate has fifty-nine patent family members in sixteen countries.

There are twenty-three drug master file entries for morphine sulfate. Forty-three suppliers are listed for this compound.

Drug Prices for morphine sulfate

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Drug Sales Revenue Trends for morphine sulfate

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Recent Clinical Trials for morphine sulfate

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
M.D. Anderson Cancer CenterPhase 3
University of Sao Paulo General HospitalPhase 3

See all morphine sulfate clinical trials

Recent Litigation for morphine sulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
INSPIRION DELIVERY SCIENCES, LLC v. TEVA PHARMACEUTICALS USA, INC.2019-04-19
PATHEON SOFTGELS INC. v. PURACAP PHARMACEUTICAL LLC2018-10-05
Fresenius Kabi USA, LLC v. Eurohealth International Sarl2018-06-01

See all morphine sulfate litigation

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
(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
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
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)
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
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
Anhydrous morphine
Avinza
BDBM50000092
BIDD:GT0147
BQJCRHHNABKAKU-KBQPJGBKSA-N
C01516
CCRIS 5762
CHEBI:17303
CHEMBL70
Cube juice
D-(-)-Morphine
D08233
DB00295
DEA No. 9300
DepoDur
Dimorf
Dinamorf
Dolcontin
Dreamer
DTXSID9023336
Dulcontin
Duramorph
Duromorph
EINECS 200-320-2
Epitope ID:116646
GTPL1627
Hard stuff
Hocus
HSDB 2134
IDS-NM-009
Infumorph
Kadian
l-Morphine
LS-91748
M-Eslon
Meconium
methyl[?]diol
MOI
MOR
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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
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
Morphium
Morpho
Moscontin
MS Contin
Ms Emma
N02AA01
Nepenthe
NSC11441
Oramorph
Oramorph SR
Ospalivina
Q81225
RMS
Roxanol
SCHEMBL2997
SDZ 202-250
SDZ202-250
Sevredol
Statex SR
Substitol (TN)
UNII-1M5VY6ITRT component BQJCRHHNABKAKU-KBQPJGBKSA-N
UNII-76I7G6D29C
Unkie
ZINC3812983
Paragraph IV (Patent) Challenges for MORPHINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
MORPHABOND ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 206544 2019-01-28
ARYMO ER TABLET, EXTENDED RELEASE;ORAL morphine sulfate 208603 2017-12-29
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-08-11
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2009-07-30
AVINZA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate 021260 2007-06-04

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
Actavis Elizabeth MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 203849-004 Apr 6, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pharm Assoc MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 206573-001 Nov 14, 2016 AA RX 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

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 021671-003 May 18, 2004   Start Trial   Start Trial
King Pharms Llc AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260-002 Mar 20, 2002   Start Trial   Start Trial
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-004 Mar 9, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
McKesson
Baxter
Mallinckrodt

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