Saquinavir - Generic Drug Details

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

Saquinavir is the generic ingredient in two branded drugs marketed by Hoffmann La Roche and Hoffmann-la Roche, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Saquinavir has forty patent family members in thirty-four countries.

There is one drug master file entry for saquinavir.

Summary for saquinavir

International Patents:	40
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Bulk Api Vendors:	39
Clinical Trials:	91
Patent Applications:	6,309
Formulation / Manufacturing:	see details
DailyMed Link:	saquinavir at DailyMed

Recent Clinical Trials for saquinavir

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

Sponsor	Phase
Temple University	Phase 4
Veloxis Pharmaceuticals	Phase 4
University of Cape Town	Phase 1

See all saquinavir clinical trials

Medical Subject Heading (MeSH) Categories for saquinavir

Cytochrome P-450 CYP3A Inhibitors
HIV Protease Inhibitors

Synonyms for saquinavir

(2S)-N-[(1S,2R)-3-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-3,4,4a,5,6,7,8,8a-octahydro-1H-isoquinolin-2-yl]-1-benzyl-2-hydroxy-propyl]-2-(quinoline-2-carbonylamino)butanediamide
(2s)-N-[(2s,3r)-4-[(2s,3s,4as,8as)-3-(Tert-Butylcarbamoyl)-3,4,4a,5,6,7,8,8a-Octahydro-1h-Isoquinolin-2-Yl]-3-Hydroxy-1-Phenyl-Butan-2-Yl]-2-(Quinolin-2-Ylcarbonylamino)butanediamide
(2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-3,4,4a,5,6,7,8,8a-octahydro-1H-isoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-(quinoline-2-carbonylamino)butanediamide
(2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-decahydroisoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-(quinolin-2-ylformamido)butanediamide
(3S-(2(1R(R),2S*),3I,4athetav,8athetav))-N(sup 1)-(3-(3-(((1,1-Dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)butanediamide
(S)-N-((IS)-I-((1R)-2-((3S,4aS,8aS)-3-(tert-Butylcarbamoyl)octahydro-2(1H)-isoquinolyl)-1-hydroxyethyl)phenethyl)-2-quinaldamidosuccinamide
(S)-N1-((2S,3R)-4-((3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl)-3-hydroxy-1-phenylbutan-2-yl)-2-(quinoline-2-carboxamido)succinamide
127779-20-8
131176-13-1
149845-06-7 (monomethanesulfonate (salt))
1hxb
2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid
24223-EP2269989A1
24223-EP2272516A2
24223-EP2272825A2
24223-EP2298761A1
24223-EP2298783A1
24223-EP2305640A2
24223-EP2305680A2
24223-EP2314590A1
2fgu
2fgv
779S208
AB00514056
ABP000344
AC-26377
AC1L9ATC
AKOS000280831
AN-32602
BC210734
BDBM50213021
BIDD:GT0323
BIDD:PXR0010
BPBio1_001373
BRD-K09963420-066-03-4
BSPBio_001248
Butanediamide, N1-((1S,2R)-3-((3S,4aS,8aS)-3-(((1,1-dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)-, (2S)-
Butanediamide, N1-(3-(3-(((1,1-dimethylethyl)amino)carbonyl)octahydro-2(1H)-isoquinolinyl)-2-hydroxy-1-(phenylmethyl)propyl)-2-((2-quinolinylcarbonyl)amino)-, (3S-(2(1R(R),2S*),3alpha,4aalpha,8aalpha))-
Butanediamide, N1-[(1S,2R)-3-[(3S,4aS,8aS)-3-[[(1,1-dimethylethyl)amino]carbonyl]octahydro-2(1H)-isoquinolinyl]-2-hydroxy-1-(phenylmethyl)propyl]-2-[(2-quinolinylcarbonyl)amino]-, (2S)-
C-23431
CC-34367
CHEBI:63621
CHEMBL114
CIS-N-TERT-BUTYL-DECAHYDRO-2-[2(R)-HYDROXY-4-PHENYL-3(S)-[[N-2-QUINOLYLCARBONYL-L-ASPARAGINYL]AMINO]BUTYL]-(4AS)-ISOQUINOLINE-3(S)-CARBOXAMIDE
CS-1180
D00429
DB01232
DTXSID6044012
Fortovase
Fortovase (TN)
Fortovase; SAQUINAVIR,RO 31-8959
Fortovase(TM)
GTPL4813
HMS2232L04
HSDB 7161
HY-17007
Invirase
Invirase(TM)(monomesylate)
L3JE09KZ2F
LS-187081
MLS001195635
MLS001304735
MRF-0000273
N-tert.butyl-decahydro -2- [2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl) -L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide
N-tert.butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide
N-tert.butyl-decahydro-2[2(R)-hydroxy-4-phenyl-3-(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide
N(1)-{(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-yl}-N(2)-(quinolin-2-ylcarbonyl)-L-aspartamide
N~1~-{(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-yl}-N~2~-(quinolin-2-ylcarbonyl)-L-aspartamide
N1-[(1S,2R)-3-[(3S,4aS,8aS)-3-[[(1,1-Dimethylethyl)amino]carbonyl]octahydro-2(1H)-isoquinolinyl]-2-hydroxy-1-(phenylmethyl)propyl]-2-[(2-quinolinylcarbonyl)amino]-butanediamide
NCGC00091469-02
NP-SQV
NSC722663
PLCG-SQV
Prestwick0_001114
Prestwick1_001114
Prestwick2_001114
Prestwick3_001114
QNC-ASN-HPH-DIQ-NTB
QWAXKHKRTORLEM-UGJKXSETSA-N
Ro 31 8959
Ro 31-8959
Ro 31-8959/000
Ro 318959
Ro-31-8959
Ro-318959000
ROC
saguinavir
Saquinavir (JAN/USP/INN)
Saquinavir [USAN:USP:INN:BAN]
Saquinavir-poly(lactide-co-glycolide)
Saquinavir/
saquinavirmesylate(subjecttopatentfree)
SC-14020
Sch 52852
SCHEMBL6881
SMR000469157
SPBio_003114
SQV
SQV-poly(lactide-co-glycolide)
UNII-L3JE09KZ2F
W-5153
ZINC3914596

US Patents and Regulatory Information for saquinavir

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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
Hoffmann La Roche	INVIRASE	saquinavir mesylate	CAPSULE;ORAL	020628-001	Dec 6, 1995		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Hoffmann-la Roche	INVIRASE	saquinavir mesylate	TABLET;ORAL	021785-001	Dec 17, 2004		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997		DISCN	Yes	No	Start Trial	Start Trial			Y	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 saquinavir

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	Start Trial	Start Trial
Hoffmann La Roche	FORTOVASE	saquinavir	CAPSULE;ORAL	020828-001	Nov 7, 1997	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for saquinavir

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Country	Patent Number	Estimated Expiration
Yugoslavia	33001	Start Trial
Austria	274895	Start Trial
Uruguay	25803	Start Trial
Japan	2002529200	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for saquinavir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432695	96C0044	Belgium	Start Trial	PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	C970013	Netherlands	Start Trial	PRODUCT NAME: SAQUINAVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0034432	96C0048	Belgium	Start Trial	PRODUCT NAME: SAQUINAVIR; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
0432695	32/1996	Austria	Start Trial	PRODUCT NAME: SAQUINAVIR UND SEINE SAEUREADDITIONSSALZE, INSBESONDERE SAQUINAVIRMESYLAT; REGISTRATION NO/DATE: EU/1/96/026/001 19961004
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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