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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 24^th, 2020.

Summary for ALTACE

International Patents:	47
US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	15
Patent Applications:	6,067
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALTACE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALTACE
DailyMed Link:	ALTACE at DailyMed

See drug prices for ALTACE

See drug sales revenues for ALTACE

Recent Clinical Trials for ALTACE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Phase 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 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 ALTACE litigation

Pharmacology for ALTACE

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

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
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007		DISCN	Yes	No
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991	AB	RX	Yes	Yes
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-004	Feb 27, 2007		DISCN	Yes	No

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
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-004	Jan 28, 1991
King Pharms Llc	ALTACE	ramipril	CAPSULE;ORAL	019901-001	Jan 28, 1991

International Patents for ALTACE

Country	Patent Number	Estimated Expiration
European Patent Office	1611886
Mexico	PA02001694
Estonia	05670
Canada	2382549

Supplementary Protection Certificates for ALTACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	C980030	Netherlands		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		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		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