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Last Updated: January 24, 2020

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ALTACE Drug Profile

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When do Altace patents expire, and when can generic versions of Altace launch?

Altace is a drug marketed by King Pharms Llc and King Pfizer and is included in two NDAs. There is one patent protecting this drug.

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

The generic ingredient in ALTACE is ramipril. There are nineteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramipril profile page.

US ANDA Litigation and Generic Entry Outlook for Altace

A generic version of ALTACE was approved as ramipril by WATSON LABS on January 24th, 2020.

  Start Trial

Drug patent expirations by year for ALTACE
Drug Prices for ALTACE

See drug prices for ALTACE

Drug Sales Revenue Trends for ALTACE

See drug sales revenues for ALTACE

Recent Clinical Trials for ALTACE

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Wake Forest University Health SciencesPhase 2
Ferrer Internacional S.A.Phase 2

See all ALTACE clinical trials

Recent Litigation for ALTACE

Identify potential future generic entrants

District Court Litigation
Case NameDate
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 ALTACE litigation

Pharmacology for ALTACE
Synonyms for ALTACE
(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 (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
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 ALTACE
Tradename Dosage Ingredient NDA Submissiondate
ALTACE CAPSULE;ORAL ramipril 019901

US Patents and Regulatory Information for ALTACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-001 Jan 28, 1991 AB RX Yes No   Start Trial   Start Trial   Start Trial
King Pfizer ALTACE ramipril TABLET;ORAL 022021-003 Feb 27, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-004 Jan 28, 1991 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
King Pfizer ALTACE ramipril TABLET;ORAL 022021-004 Feb 27, 2007 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 ALTACE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-004 Jan 28, 1991   Start Trial   Start Trial
King Pfizer ALTACE ramipril TABLET;ORAL 022021-002 Feb 27, 2007   Start Trial   Start Trial
King Pharms Llc ALTACE ramipril CAPSULE;ORAL 019901-004 Jan 28, 1991   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

Supplementary Protection Certificates for ALTACE

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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