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SULAR Drug Profile

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When do Sular patents expire, and what generic alternatives are available?

Sular is a drug marketed by Covis Pharma Bv and is included in one NDA.

The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

US ANDA Litigation and Generic Entry Outlook for Sular

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A generic version of SULAR was approved as nisoldipine by MYLAN on January 17^th, 2020.

Summary for SULAR

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	84
Patent Applications:	4,234
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SULAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SULAR
DailyMed Link:	SULAR at DailyMed

Drug patent expirations by year for SULAR

Recent Litigation for SULAR

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Endo Pharmaceuticals Inc. v. Sandoz Inc.	2008-08-22
UCB Inc. v. KV Pharmaceutical Company	2008-04-18
Sanofi-Aventis v. Wockhardt Limited	2008-03-14

See all SULAR litigation

Pharmacology for SULAR

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists
Physiological Effect	Decreased Blood Pressure

Synonyms for SULAR

(.+/-.)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
(.+/-.)-Nisoldipine
(+-)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
(+/-)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate
1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Isobutyl Methyl Ester
1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid methyl 2-methylpropyl ester
2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid O3-methyl ester O5-(2-methylpropyl) ester
3-Isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate #
3-Isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3-methyl 5-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3-O-methyl 5-O-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (.+/-.)-
3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (+-)-
63675-72-9
675N729
A834466
AB0106136
AB01275444_02
AB01275444-01
AB2000270
AC-987
AC1L1IAY
AKOS005563632
AN-6975
Bay k 5552
BAY-k 5552
Bay-k-5552
Baymycard
BBL028683
BC204167
BCP22696
BDBM50101963
BDBM50227259
BIDD:GT0684
BRD-A84465106-001-01-2
BRN 0454188
C07699
C20H24N2O6
CAS-63675-72-9
CCG-100894
CCG-213412
CHEBI:76917
CHEMBL1726
CHEMBL3192341
CHEMBL441428
CPD004727075
CS-1131
CTK8G1888
D00618
DB00401
DL-255
DSSTox_CID_3371
DSSTox_GSID_23371
DSSTox_RID_76999
DTXSID0023371
EINECS 264-407-7
FT-0082489
FT-0601599
GTPL2524
HMS2051O18
HMS2089K20
HMS2093F15
HMS2097E13
HMS2231L20
HMS3393O18
HMS3651K17
HMS3714E13
HY-17402
Isobutyl 1,4-dihydro-5-methoxycarbonyl-2,6-dimethyl-4-(2-nitrophenyl)-3-pyridincarboxylat
Isobutyl Methyl 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate
isobutyl methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
J10291
KM0774
KS-000001QK
KS-5188
LS-131295
MCULE-5009799152
methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
MFCD00478055
MLS000759498
MLS001424102
MLS002153943
MolPort-003-666-664
N0900
NC00144
NCGC00164633-01
NCGC00164633-02
NCGC00164633-03
NCGC00255136-01
Nisocor
Nisoldipin
Nisoldipina
nisoldipine
Nisoldipine (JAN/USAN/INN)
nisoldipine (product)
Nisoldipine [USAN:BAN:INN:JAN]
Nisoldipine [USAN:INN:BAN:JAN]
Nisoldipine, >=98% (HPLC)
Nisoldipine, ~97%
Nisoldipine,(S)
Nisoldipine;
Nisoldipino
Nisoldipino [INN-Spanish]
Nisoldipinum
Nisoldipinum [INN-Latin]
NSC-759106
NSC759106
O3-methyl O5-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
O5-isobutyl O3-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
O5-methyl O3-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
Pharmakon1600-01505390
s1748
SAM001246719
SBI-0206830.P001
SC-18015
SCHEMBL39779
SMR000466370
SR-05000002009
SR-05000002009-1
SR-05000002009-2
SR-05000002009-3
ST24042247
STK631543
Sular (TN)
SW219237-1
Syscor
Tox21_112251
Tox21_112251_1
Tox21_302365
VKQFCGNPDRICFG-UHFFFAOYSA-N
Z277942268
Zadipina
Zadipina;Bay k 5552;Baymycard;Sular

Paragraph IV (Patent) Challenges for SULAR

Tradename	Dosage	Ingredient	NDA	Submissiondate
SULAR	TABLET, EXTENDED RELEASE;ORAL	nisoldipine	020356	2009-03-02
SULAR	TABLET, EXTENDED RELEASE;ORAL	nisoldipine	020356	2008-11-28
SULAR	TABLET, EXTENDED RELEASE;ORAL	nisoldipine	020356	2007-11-07
SULAR	TABLET, EXTENDED RELEASE;ORAL	nisoldipine	020356	2007-06-11

US Patents and Regulatory Information for SULAR

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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
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995		DISCN	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 SULAR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	Start Trial	Start Trial
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995	Start Trial	Start Trial
Covis Pharma Bv	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration