Ramipril - Generic Drug Details

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What are the generic sources for ramipril and what is the scope of patent protection?

Ramipril is the generic ingredient in two branded drugs marketed by King Pharms Llc, Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Chartwell Molecular, Cipla, Dr Reddys Labs Ltd, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, West-ward Pharms Int, Yaopharma Co Ltd, Zydus Pharms Usa, King Pfizer, Apotex Inc, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ramipril has forty-seven patent family members in thirty-two countries.

There are nineteen drug master file entries for ramipril. Twenty-three suppliers are listed for this compound.

Summary for ramipril

International Patents:	47
US Patents:	1
Tradenames:	2
Applicants:	19
NDAs:	19
Drug Master File Entries:	19
Suppliers / Packagers:	23
Bulk Api Vendors:	79
Clinical Trials:	138
Patent Applications:	6,598
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ramipril
Drug Sales Revenues:	Drug sales revenues for ramipril
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ramipril
DailyMed Link:	ramipril at DailyMed

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See drug sales revenues for ramipril

Recent Clinical Trials for ramipril

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indonesia University	Phase 3
Hospices Civils de Lyon	Phase 3
Quantum Genomics SA	Phase 2

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Recent Litigation for ramipril

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.	2006-05-02
Boehringer Ingelheim International GMBH v. Barr Laboratories, Inc.	2005-09-26
Aventis Pharma Deutschland GmbH v. Lupin Ltd.	2005-07-15

See all ramipril litigation

Pharmacology for ramipril

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Medical Subject Heading (MeSH) Categories for ramipril

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Synonyms for ramipril

(2 S ,3 aS ,6 aS )-1[( S )-N-[( S )-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b ]pyrrole-2-carboxylic acid, 1-ethyl ester
(2S-(1(R(R)),2alpha,3abeta,6abeta))-1-(2-((1-(Ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydrocyclopenta(b)pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-(((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-L-alanyl)octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-((S)-2-(((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)amino)propanoyl)octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-((S)-2-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)propanoyl) octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2s,3as,6as)-1-((s)-2-((s)-1-ethoxy-1-oxo-4-phenylbutan-2-ylamino)propanoyl)-octahydrocyclopenta[b]p
(2S,3aS,6aS)-1-((S)-N-((S)-1-Carboxy-3-phenylpropyl)alanyl)octahydrocyclopenta(b)pyrrole-2-carboxylic acid, 1-ethyl ester
(2S,3aS,6aS)-1-((S)-N-((S)-1-Ethoxycarbonyl-3-phenylpropyl)alanyl)octahydrocyclopenta(b)pyrrol-2-carbonsaeure
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]-3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino]propanoyl]-3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[d]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-{[(1S)-1-ethoxycarbonyl-3-phenylpropyl]amino}propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}propanoyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid
(2S,3aS,6aS)-1-[(2S)-2-{[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]amino}propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (non-preferred name)
(2s,3as,6as)-1-[(s)-2-((s)-1-ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-octahydro-cyclopenta[b]
(2s,3as,6as)-1((s)-n-((s)-1-carboxy-3-phenylpropyl)alanyl)octahydrocyclopenta(b)pyrrole-2-carboxylic
[2s,3as,6as]-1-[(2s)-2-[[(1s)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydrocyclopen
[2S,3aS,6aS]-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid
1-[2-(1-Ethoxycarbonyl-3-phenyl-propylamino)-propionyl]-octahydro-cyclopenta[b]pyrrole-2-carboxylic acid(Ramipril)
126613-39-6
333R195
87333-19-5
88094-EP2270011A1
88094-EP2272841A1
88094-EP2277879A1
88094-EP2287165A2
88094-EP2287166A2
88094-EP2292620A2
88094-EP2298742A1
88094-EP2298776A1
88094-EP2298779A1
88094-EP2301923A1
88094-EP2301931A1
88094-EP2301936A1
88094-EP2305648A1
AB0008490
AB00698339_09
AB00698339_10
AB00698339-07
AB00698339-08
AB07503
AB2000297
AC-1347
AC1NSFPR
Acovil
AKOS005622534
Altace
Altace (TN)
AN-15038
B2208
BBL033964
BC205360
BDBM50084681
BIDD:GT0803
BSPBio_003347
C23H32N2O5
Carasel
Cardace
CAS-87333-19-5
CCG-100833
CHEBI:8774
CHEMBL1168
CPD000466386
CS-2270
CTK8G2889
Cyclopenta(b)pyrrole-2-carboxylic acid, 1-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydro-, (2S-(1(R(R)),2alpha,3abeta,6abeta))-
Cyclopenta(b)pyrrole-2-carboxylic acid, 1-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydro-, (2S(1(R(R)),2alpha,3abeta,6abeta))-
D00421
DB00178
Delix
DSSTox_CID_3551
DSSTox_GSID_23551
DSSTox_RID_77077
DTXSID8023551
GTPL6339
HDACQVRGBOVJII-JBDAPHQKSA-N
HMS2051E04
HMS2090L11
HMS2093M10
HMS2231M05
HMS3259J07
HMS3715M16
HOE 498
Hoe-498
HOE498
HY-B0279
Hypren
Hytren
J90014
KBio2_002504
KBio2_005072
KBio2_007640
KBio3_002849
KBioGR_001858
KBioSS_002512
KS-1103
L35JN3I7SJ
Lostapres
LS-58199
MCULE-5386328912
MFCD00865775
MLS000759523
MLS001216547
MLS001423965
MolPort-001-736-571
N-(1S-carboethoxy-3-phenylpropyl)-S-alanyl-cis,endo-2-azabicyclo[3.3.0]octane-3S-carboxylic Acid
Naprix
NC00083
NC00627
NCGC00016955-01
NCGC00178127-01
NCGC00178127-02
NE42859
NPD2431
NSC-758933
NSC758933
Pharmakon1600-01505214
Pramace
Pramace (discontinued)
Prilace
Quark
Ramace
Ramipril (Altace)
Ramipril (USP/INN)
Ramipril [USAN:INN:BAN]
Ramipril [USAN:USP:INN:BAN]
Ramipril, >=98% (HPLC)
Ramipril, British Pharmacopoeia (BP) Reference Standard
Ramipril, European Pharmacopoeia (EP) Reference Standard
Ramipril, Pharmaceutical Secondary Standard; Certified Reference Material
Ramipril, United States Pharmacopeia (USP) Reference Standard
Ramiprilum
Ramiprilum [Latin]
Ramipro
Ramipro;Tritace;Prilace;Altace
s1793
SAM001246757
SAM002699899
SBI-0206728.P001
SC-17348
SCHEMBL16059
SMR000466386
Spectrum_001958
SPECTRUM1505214
Spectrum3_001794
Spectrum4_001269
Spectrum5_001721
SR-05000001908
SR-05000001908-1
SR-05000001908-2
STK801937
Tox21_110708
Tox21_110708_1
Triatec
Tritace
UNII-L35JN3I7SJ
Unipril
Vesdil
Z1946144927
ZINC3798757

Paragraph IV (Patent) Challenges for RAMIPRIL

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALTACE	CAPSULE;ORAL	ramipril	019901

US Patents and Regulatory Information for ramipril

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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
Actavis Elizabeth	RAMIPRIL	ramipril	CAPSULE;ORAL	077513-001	Jun 18, 2008		DISCN	No	No	Start Trial	Start Trial				Start Trial
Watson Labs	RAMIPRIL	ramipril	CAPSULE;ORAL	076549-002	Oct 24, 2005	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Actavis Elizabeth	RAMIPRIL	ramipril	CAPSULE;ORAL	077513-003	Jun 18, 2008		DISCN	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 ramipril

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-003	Jan 28, 1991	Start Trial	Start Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007	Start Trial	Start Trial
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ramipril

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Country	Patent Number	Estimated Expiration
Bulgaria	65474	Start Trial
New Zealand	530702	Start Trial
Canada	2382549	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ramipril

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	C980030	Netherlands	Start Trial	PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0265685	99C0001	Belgium	Start Trial	PRODUCT NAME: FELODIPINUM + RAMIPRILUM; NATL. REGISTRATION NO/DATE: 354 IS 373 F 3 19981103; FIRST REGISTRATION: SE 13597 19970919
0265685	SPC/GB98/047	United Kingdom	Start Trial	PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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