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Generated: April 20, 2019

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Mycophenolate mofetil - Generic Drug Details

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What are the generic drug sources for mycophenolate mofetil and what is the scope of mycophenolate mofetil patent protection?

Mycophenolate mofetil is the generic ingredient in three branded drugs marketed by Roche Palo, Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Concord Biotech Ltd, Dr Reddys Labs Ltd, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Vintage Pharms Llc, West-ward Pharms Int, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Vistapharm, Apotex, Oxford Pharms, Akorn Inc, Mylan Labs Ltd, and Par Sterile Products, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for mycophenolate mofetil. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for mycophenolate mofetil
Synonyms for mycophenolate mofetil
(E)-2-Morpholinoethyl 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
(E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid 2-(4-Morpholinyl)ethyl Ester
(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-isobenzofuran-5-yl)-4-methyl-4-hexenoic acid 2-(4-morpholinyl)ethyl ester
007M346
115007-34-6
128794-94-5
140401-05-4
2-(4-Morpholinyl)ethyl (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate
2-(morpholin-4-yl)ethyl (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoate
2-morpholin-4-ylethyl (4E)-6-[4-hydroxy-7-methyl-6-(methyloxy)-3-oxo-1,3-dihydro-2-benzofuran-5-yl]-4-methylhex-4-enoate
2-morpholin-4-ylethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoate
2-morpholin-4-ylethyl (E)-6-(6-methoxy-7-methyl-4-oxidanyl-3-oxidanylidene-1H-2-benzofuran-5-yl)-4-methyl-hex-4-enoate
2-morpholin-4-ylethyl 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoate
2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-isobenzofuran-5-yl)-4-methyl-hex-4-enoate
2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate
4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl ester, (E)-
4-Hexenoic acid,3-dihydro-4-hydroxy-6-methoxy-7-methyl -3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl ester, (4E)
6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid 2-(4-morpholinyl)ethyl ester
9242ECW6R0
A803280
A805863
AB0125583
AB01274794_03
AB01274794_04
AB01274794-01
AB01274794-02
AB07560
ABP000539
AC-1562
AC1NQXZW
AC1Q6O6X
ACT01993
AJ-78121
AK-98658
AKOS005720900
ALBB-027273
AN-14797
AN-33289
AOB5505
BBL029073
BC225627
BC283431
BCP12786
BCP27678
BCP9000969
BRD-K92428153-001-01-0
C07908
C23H31NO7
CAS-128794-94-5
CCG-213315
CellCept
Cellcept (TN)
CHEBI:8764
CHEBI:93612
CHEMBL1456
CS-2135
D00752
DB00688
DSSTox_CID_3340
DSSTox_GSID_23340
DSSTox_RID_76982
DTXSID3023340
GTPL6831
HMS2090A03
HSDB 7436
HY-B0199
I01-0898
I06-1947
J-005626
J90063
KS-1209
LS-172272
LS-75572
M2387
ME-MPA
MFCD00867568
MLS003915627
MLS004774133
MLS006011929
MMF CellCept(TM)
Mofetil mycophenolate
MolPort-000-883-800
morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate
Morpholinoethyl E-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate
Morpholinoethyl E-6-(1,3-dihydro-4-hydroxy-6-methoxy-7methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate
Munoloc
Mycophenolate mofetil (CellCept)
Mycophenolate mofetil (JAN/USAN)
Mycophenolate mofetil [USAN:USP]
Mycophenolate mofetil for peak identification, European Pharmacopoeia (EP) Reference Standard
Mycophenolate mofetil Teva
Mycophenolate mofetil, >=98% (HPLC)
Mycophenolate mofetil, 98%
Mycophenolate mofetil, European Pharmacopoeia (EP) Reference Standard
Mycophenolate Mofetil, Pharmaceutical Secondary Standard; Certified Reference Material
Mycophenolate mofetil, United States Pharmacopeia (USP) Reference Standard
Mycophenolate mofetil(CellCept)/
Mycophenolatemofetil
Mycophenolatmofetil
Mycophenolic acid morpholinoethyl ester
Mycophenylate mofetil
Myfenax
NCGC00159459-02
NCGC00159459-03
NCGC00159459-04
NSC-724229
NSC-758905
NSC724229
NSC758905
Pharmakon1600-01504567
Q-101316
R-99
R3925
RS 61443
RS-61443
RS-61443-190
RTGDFNSFWBGLEC-SYZQJQIISA-N
s1501
SC-19049
SCHEMBL218782
SCHEMBL4195
SMR002544686
SMR004703518
SR-05000001485
SR-05000001485-1
SR-05000001485-2
ST24035026
STL146382
SW219893-1
TL8000648
TM-MMF
Tox21_111686
Tox21_111686_1
UNII-9242ECW6R0
ZINC21297660
Tentative approvals for MYCOPHENOLATE MOFETIL
Applicant Application No. Strength Dosage Form
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US Patents and Regulatory Information for mycophenolate mofetil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065491-001 May 6, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065413-001 Jul 29, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090464-001 Sep 13, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zhejiang Hisun Pharm MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 204076-001 Nov 16, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090499-001 Apr 22, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jubilant Cadista MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090661-001 Dec 15, 2014 DISCN No No ➤ 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 mycophenolate mofetil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CELLCEPT mycophenolate mofetil SUSPENSION;ORAL 050759-001 Oct 1, 1998 ➤ Sign Up ➤ Sign Up
Roche Palo CELLCEPT mycophenolate mofetil TABLET;ORAL 050723-001 Jun 19, 1997 ➤ Sign Up ➤ Sign Up
Roche Palo CELLCEPT mycophenolate mofetil CAPSULE;ORAL 050722-001 May 3, 1995 ➤ Sign Up ➤ Sign Up
Roche Palo CELLCEPT mycophenolate mofetil SUSPENSION;ORAL 050759-001 Oct 1, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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