Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 22, 2019

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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 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, Piramal Critical, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Ani Pharms Inc, Hi Tech, 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, Hikma, 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-seven patent family members in fifteen 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
Aristotle University Of ThessalonikiPhase 4
National Cancer Institute, EgyptPhase 3
Fayoum UniversityPhase 4

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
(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
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, (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
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 2009-07-30
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
West-ward Pharms Int MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 022195-001 Mar 17, 2008 AA RX Yes No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 091357-004 Jun 23, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Specgx Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076412-001 Jul 31, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 RX Yes 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
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-002 May 18, 2004   Start Trial   Start Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004   Start Trial   Start Trial
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-005 Mar 9, 2001   Start Trial   Start Trial
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-002 Jul 3, 1996   Start Trial   Start Trial
Pacira Pharms Inc DEPODUR morphine sulfate INJECTABLE, LIPOSOMAL;EPIDURAL 021671-003 May 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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