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Serving hundreds of leading biopharmaceutical companies globally:

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Cipla
Healthtrust
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Generated: August 18, 2018

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Mycophenolic acid - Generic Drug Details

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What are the generic drug sources for mycophenolic acid and what is the scope of mycophenolic acid freedom to operate?

Mycophenolic acid is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex Inc, Mylan Pharms Inc, Teva Pharms Usa, and Novartis, and is included in five NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mycophenolic acid has fifty-nine patent family members in thirty-eight countries.

There are seventeen drug master file entries for mycophenolic acid. Seven suppliers are listed for this compound.

Pharmacology for mycophenolic acid
Medical Subject Heading (MeSH) Categories for mycophenolic acid
Synonyms for mycophenolic acid
(4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
(4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid (Mycophenolic Acid)
(4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxohydroisobenzofuran-5-yl)-4-methylhex -4-enoic acid
(E)-6-(1,3-dihydro-4-hydroxy-6- methoxy-7-methyl-3-oxoisobenzofuran-5-yl)-4-methyl-4-hexenoic acid
(E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid
(E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxoisobenzofuran-5-yl)-4-methyl-4-hexenoic acid
(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid
(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1H-isobenzofuran-5-yl)-4-methyl-hex-4-enoic acid
(E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid
(Z)-Mycophenolic Acid
1185242-90-3
1jr1
24280-93-1
280M931
4-Hexenoic acid, (E)-
4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (4E)-
4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (4E)- (9CI)
4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, (E)-
4-Hexenoic acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, (E)-
4-Hexenoic acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, (E)- (8CI)
4-Hexenoic acid,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5- isobenzofuranyl)-4-methyl-, (E)-
4-Methyl-5-methoxy-7-hydroxy-6-(5-carboxy-3-methylpent-2-en-1-yl)-phthalide (E)-
4-Methyl-6-[3-oxo-7-methyl-4-hydroxy-6-methoxy-1,3-dihydroisobenzofuran-5-yl]-4-hexenoic acid
483-60-3
6- -4-methylhex-4-enoicacid
6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid
6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic acid
6-(1,3-Dihydro-7-hydroxy-5-methoxy-4-methyl-1-oxoisobenzofuran-6-yl)-4-methyl-4-hexanoic acid
6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid
6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid (E)-
6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthanlanyl)-4-methyl-4-hexanoic acid
6-[4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl]-4-methyl-4-hexenoic acid
A-249
AB00052466_15
AB00052466_16
AB00052466-13
AB00052466-14
AB0011511
AB2000593
AC-4491
AC1L9JSG
AC1Q6HP2
Acide mycophenolique
Acide mycophenolique [INN-French]
Acido micofenolico
Acido micofenolico [INN-Spanish]
Acidum mycophenolicum
Acidum mycophenolicum [INN-Latin]
ACon0_000960
ACon1_000496
ACT02623
AJ-08079
AK-34309
AKOS015888214
AN-7044
AOB5506
API0024821
BBL034696
BC218915
BCP9000970
BDBM19264
BIDD:GT0456
BPBio1_000695
BR-34309
BRD-K63750851-001-06-6
BSPBio_000631
BSPBio_002534
C17H20O6
C20380
CAS-24280-93-1
CCG-39914
CCRIS 5565
CHEBI:168396
CHEBI:92545
CHEMBL866
CS-2527
D05096
DB01024
DS-1638
DSSTox_CID_21070
DSSTox_GSID_41070
DSSTox_RID_79619
DTXSID4041070
E-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic acid
EC 246-119-3
EINECS 207-595-8
EINECS 246-119-3
EN300-122327
EX-A975
GTPL6832
HE004683
HE328066
HMS1569P13
HMS1921A18
HMS2089A17
HMS2092G22
HMS2096P13
HMS2268H22
HMS3403P09
HMS500H08
HPNSFSBZBAHARI-RUDMXATFSA-N
HU9DX48N0T
HY-B0421
I01-0943
IDI1_000146
Lilly 68618
Lilly-68618
LS-75578
Ly 68618
M 5255
M-1202
M2216
MCULE-1991681277
MEGxm0_000120
Melbex
MFCD00036814
Micofenolico acido
Micofenolico acido [Spanish]
MLS001074701
MLS002222265
MLS002695945
MOA
MolPort-001-732-316
Mycophenoic acid
Mycophenolate
Mycophenolic (Mycophenolate)
Mycophenolic Acid (MPA)
Mycophenolic acid (USAN/INN)
Mycophenolic acid [USAN:BAN:INN]
Mycophenolic acid [USAN:INN:BAN]
Mycophenolic acid, >=98%
Mycophenolic acid, analytical standard
Mycophenolic acid, powder, BioReagent, suitable for cell culture, >=98%
mycophenolicacid
Mycophenolsaeure
Mycophenolsaure
Myfortic
Myfortic (mycophenolate sodium)
Myfortic (TN)
NCGC00016786-01
NCGC00016786-02
NCGC00016786-03
NCGC00016786-04
NCGC00016786-05
NCGC00016786-06
NCGC00016786-07
NCGC00016786-08
NCGC00016786-09
NCGC00016786-10
NCGC00016786-11
NCGC00016786-12
NCGC00016786-15
NCGC00025190-01
NCGC00025190-02
NCGC00025190-03
NCGC00025190-04
NCGC00025190-05
NCGC00025190-07
NCGC00025190-08
NCGC00025190-09
NCGC00025190-10
NSC 129185
NSC-129185
NSC-757424
NSC129185
NSC757424
Pharmakon1600-01500674
Prestwick_817
Prestwick2_000556
Prestwick3_000556
RS-61443 [AS MOFETIL]
s2487
SBI-0051945.P003
SC-14135
SCHEMBL2514376
SCHEMBL4549
SDCCGMLS-0066618.P001
SMR000471887
SPECTRUM1500674
Spectrum5_001654
SR-01000597602
SR-01000597602-3
ST044516
ST2418864
STL419986
TNP00198
Tocris-1505
Tox21_110610
Tox21_110610_1
UNII-HU9DX48N0T
UPCMLD-DP028
UPCMLD-DP028:001
ZINC1758

US Patents and Regulatory Information for mycophenolic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202555-002 Aug 23, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091558-002 Aug 19, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091248-002 Jan 8, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharms Usa MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202720-001 Oct 30, 2014 AB RX 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 mycophenolic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ➤ Sign Up ➤ Sign Up
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Sign Up ➤ Sign Up
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Sign Up ➤ Sign Up
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Sign Up ➤ Sign Up
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 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 mycophenolic acid

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
6,025,391 Enteric-coated pharmaceutical compositions of mycophenolate ➤ Sign Up
6,172,107 Entric-coated pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for mycophenolic acid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0157 Netherlands ➤ Sign Up 300157, 20170410, EXPIRES: 20181009
C/GB04/030 United Kingdom ➤ Sign Up SPC/GB04/030: 20050609, EXPIRES: 20171023
C017/2004 Ireland ➤ Sign Up SPC017/2004, 20060201, EXPIRES: 20171023
0892640/01 Switzerland ➤ Sign Up PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
094 Luxembourg ➤ Sign Up 91094, EXPIRES: 20181010
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Dow
Express Scripts
US Department of Justice
Mallinckrodt
McKinsey
QuintilesIMS
Queensland Health
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.