Olmesartan medoxomil - Generic Drug Details

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What are the generic sources for olmesartan medoxomil and what is the scope of freedom to operate?

Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Qilu Pharm Co Ltd, Sciegen Pharms Inc, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for olmesartan medoxomil. Twenty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for olmesartan medoxomil

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	36
Suppliers / Packagers:	26
Bulk Api Vendors:	103
Clinical Trials:	70
Patent Applications:	5,321
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for olmesartan medoxomil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olmesartan medoxomil
DailyMed Link:	olmesartan medoxomil at DailyMed

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Recent Clinical Trials for olmesartan medoxomil

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Sponsor	Phase
Pharmtechnology LLC	Phase 1
Altasciences Company Inc.	Phase 1
Daiichi Sankyo Co., Ltd.	Phase 3

See all olmesartan medoxomil clinical trials

Recent Litigation for olmesartan medoxomil

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Apotex Inc. v. Daiichi Sankyo, Inc.	2016-05-16
Aurobindo Pharmaceuticals Limited v. Daiici Sankyo, Inc.	2016-05-02
Apotex Inc v. Daiichi Sankyo, Inc.	2015-04-27

See all olmesartan medoxomil litigation

Generic filers with tentative approvals for OLMESARTAN MEDOXOMIL

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	40MG	TABLET; ORAL
Start Trial	Start Trial	20MG	TABLET; ORAL
Start Trial	Start Trial	5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for olmesartan medoxomil

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for olmesartan medoxomil

Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents

Synonyms for olmesartan medoxomil

(5-methyl-2-oxidanylidene-1,3-dioxol-4-yl)methyl 5-(2-oxidanylpropan-2-yl)-2-propyl-3-[[4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-h
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-i midazole-5-carboxylate
(5-Methyl-2-oxo-1,3-dioxol-4-yl)Methyl 1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)Methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-iMidazole-5-carboxylate
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1H-imidazole-5-carboxylate
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-[[2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl]-4-(2-hydroxypr
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxy-2-propanyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)-4-biphenylyl]methyl]-1H-imidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(1-hydroxy-1-methyl-ethyl)-2-propyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)imidazole-4-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(1H-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
(5-Methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazole-5-carboxylate
(5-Methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate
(5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenylmethyl}imidazol-5-carboxylate;
(5-Methyl-2-oxo-1,3-dioxolen-4yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate
(5-methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1H-imidazole-5-carboxylate
(5-methyl-2-oxo-2H-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1H-imidazole-5-carboxylate
144689-63-4
1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1H-tetrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl ester
1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-,(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
1H-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
5-(1-HYDROXY-1-METHYLETHYL)-2-PROPYL-3-[2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YLMETHYL]-3H-IMIDAZOLE-4-CARBOXYLIC ACID 5-METHYL-2-OXO-[1,3]DIOXOL-4-YLMETHYL ESTER
5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-4-imidazolecarboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
689O634
6M97XTV3HD
A808260
AB0012006
AB01275443_02
AB01275443_03
AB01275443-01
AB1009487
AC-1601
AC1L2Y71
AKOS015894907
AKOS015914772
AN-1125
AOB3863
BC208264
BC209016
BCP05214
BCP9000555
BDBM50442892
Benevas
Benicar
Benicar (TN)
BR-72894
BRD-K78485176-001-02-9
BRD-K78485176-001-03-7
BSPBio_003491
C29H30N6O6
CAS-144689-63-4
CCG-221184
CCG-39596
CHEBI:31932
CHEMBL1200692
CPD004727564
CS-0577
CS-866
CS-866DM
CS-866RN
CS866
D01204
DSSTox_CID_25924
DSSTox_GSID_45924
DSSTox_RID_81226
DTXSID9045924
EBD35964
FT-0601603
GTPL591
HMS1922L15
HMS2089K18
HMS2093K16
HMS3651E13
HMS3715N09
HY-17005
I06-0025
I14-41691
J-501595
J10058
KBio2_002490
KBio2_005058
KBio2_007626
KBio3_002711
KBioGR_001040
KBioSS_002498
KS-00000IVQ
KS-1182
L001061
LS-181818
MCULE-2480015750
MLS006010109
NCGC00095136-01
NCGC00095136-02
NCGC00095136-03
NSC-758924
NSC758924
O0510
Olmesartan (medoxomil)
Olmesartan medoxomil (Benicar)
Olmesartan medoxomil (JP17/USAN)
Olmesartan medoxomil [USAN:INN:BAN]
Olmesartan medoxomil for system suitability, European Pharmacopoeia (EP) Reference Standard
Olmesartan medoxomil tablets (JP17)
Olmesartan medoxomil, >=98% (HPLC)
Olmesartan medoxomil, European Pharmacopoeia (EP) Reference Standard
Olmesartan Medoxomil, Pharmaceutical Secondary Standard; Certified Reference Material
Olmesartan medoxomil, United States Pharmacopeia (USP) Reference Standard
Olmesartan medoxomil\|4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-Imidazole-5-carboxylic acid-(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
Olmetec
Olmetec (TN)
Olmetec; 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1Htetazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl ester
Olsertain
Olvance
Openvas
Pharmakon1600-01505205
RP17784
S-1787
s1604
SAM001246634
SB19327
SBI-0206741.P001
SC-17112
SCHEMBL16403
SMR002203616
SPBio_000431
Spectrum_001944
SPECTRUM1505205
Spectrum2_000506
Spectrum3_001676
Spectrum4_000740
Spectrum5_001556
SR-05000001987
SR-05000001987-1
SR-05000001987-2
ST24031498
STL451024
SW199650-2
Tox21_111445
UNII-6M97XTV3HD
UQGKUQLKSCSZGY-UHFFFAOYSA-N
votume
Z1550675457
ZINC4149248

Paragraph IV (Patent) Challenges for OLMESARTAN MEDOXOMIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
BENICAR	TABLET;ORAL	olmesartan medoxomil	021286	2006-04-25

US Patents and Regulatory Information for olmesartan medoxomil

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qilu Pharm Co Ltd	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	210552-002	Jan 10, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Sunshine Lake	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	211049-003	Feb 22, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Torrent	OLMESARTAN MEDOXOMIL	olmesartan medoxomil	TABLET;ORAL	202375-002	Apr 24, 2017	AB	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 olmesartan medoxomil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Daiichi Sankyo	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	Start Trial	Start Trial
Daiichi Sankyo	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-004	Apr 25, 2002	Start Trial	Start Trial
Daiichi Sankyo	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-003	Apr 25, 2002	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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