Ribavirin - Generic Drug Details

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

Ribavirin is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Kadmon Pharms Llc, Aurobindo Pharma, Casi Pharms Inc, Teva, Zydus Pharms Usa, Navinta Llc, Valeant Pharm Intl, Schering, Roche, Beximco Pharms Usa, Heritage Pharma, and Sandoz, and is included in sixteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ribavirin has thirty-three patent family members in twenty-six countries.

There are fifteen drug master file entries for ribavirin. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ribavirin

International Patents:	33
US Patents:	1
Tradenames:	5
Applicants:	13
NDAs:	16
Drug Master File Entries:	15
Suppliers / Packagers:	7
Bulk Api Vendors:	94
Clinical Trials:	957
Patent Applications:	7,375
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ribavirin
DailyMed Link:	ribavirin at DailyMed

See drug prices for ribavirin

Recent Clinical Trials for ribavirin

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

Sponsor	Phase
Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.	Phase 3
Assiut University	Early Phase 1
Ottawa Hospital Research Institute	Phase 3

See all ribavirin clinical trials

Generic filers with tentative approvals for RIBAVIRIN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	40MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ribavirin

Drug Class	Nucleoside Analog Antiviral

Medical Subject Heading (MeSH) Categories for ribavirin

Antimetabolites
Antiviral Agents

Synonyms for ribavirin

1-?-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide
1-.beta.-D-Ribofuranosyl-1,2,4-triazolo-3-carboxamide
1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-1,2,4-triazole-3-carboxamide
1-(beta -D-ribofuranosyl)-1,2,4-triazole-3-carboxamide
1-(beta-D-Ribofuranosyl)-1,2,4-triazole-3-carboxamide
1-(beta-D-ribofuranosyl)-1H-1,2,4-triazole-3-carboxamide
1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,2,4-triazole-3-carboxamide
1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1H-1,2,4-triazole-3-carboxamide
1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1,2,4-triazole-3-carboxamide
1-\|A-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide
1-beta-D-ribofuranosyl-1-H-1,2,4-triazole-3-carboxamide
1-beta-D-Ribofuranosyl-1,2,4-triazole-3-carboxamide
1-beta-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide
1-beta-Ribofuranosyl-1,2,4-triazole-3-carboamide
1,2,4-Triazole-3-carboxamide, 1-beta-D-ribofuranosyl-
1H-1,2,4-Triazole-3-carboxamide, 1-beta-D-ribofuranosyl-
36791-04-5
437710-49-1
49717AWG6K
4pb1
66510-90-5
791R045
AB00430481
AB00430481_17
AB00430481_18
AB00430481-15
AB00430481-16
AB0068936
AC1L1XXZ
AC1Q1IDC
AC1Q4ZGS
AJ-24715
AK-49185
AKOS001715163
API0004062
AS-34178
AX8005387
BB_NC-00567
BCP0726000138
BDBM50154375
BIB6306
BPBio1_001195
BR-49185
BRD-K60369935-001-02-7
BRD-K60369935-001-18-3
BRN 0892462
BSPBio_001085
BSPBio_003352
C-14783
C-Virin
CAS-36791-04-5
CC-34249
CCG-38985
CHEBI:63580
CHEMBL1643
cid_37542
Copegus
Copegus (TN)
Cotronak
CPD000058315
CS-2540
CTK7J7594
D00423
DB00811
DivK1c_000782
DRG-0028
Drug: Ribavirin
DSSTox_CID_3557
DSSTox_GSID_23557
DSSTox_RID_77081
DTXSID8023557
EN300-59237
EU-0101063
FT-0082885
FT-0630597
FT-0649908
GS-3572
GTPL6842
HMS2090L15
HMS2094O09
HMS2098G07
HMS2232P07
HMS3263E08
HMS3715G07
HMS502H04
HSDB 6513
HY-B0434
ICN-1229
IDI1_000782
IWUCXVSUMQZMFG-AFCXAGJDSA-N
J10190
KBio1_000782
KBio2_002328
KBio2_004896
KBio2_007464
KBio3_002854
KBioGR_001804
KBioSS_002331
Lopac0_001063
LP01063
LS-1241
M-7546
MCULE-9495128592
MFCD00058564
MLS000028486
MLS002222317
MolPort-002-507-104
NCGC00015904-02
NCGC00090726-01
NCGC00090726-03
NCGC00090726-04
NCGC00090726-05
NCGC00090726-06
NCGC00090726-07
NCGC00090726-08
NCGC00090726-09
NCGC00090726-12
NCGC00258520-01
NCGC00261748-01
NINDS_000782
NSC 163039
NSC-758650
NSC163039
NSC758650
Pharmakon1600-01503938
Prestwick3_000993
PubChem14187
R 9644
R-964
R0077
Ravanex
RBV
Rebetol
Rebetol (TN)
Rebetron
Rebretron
RG-964
Ribacine
Ribamide
Ribamidil
Ribamidyl
Ribasphere
Ribasphere (TN)
Ribav
Ribavirin (Copegus)
Ribavirin (JP17/USP/INN)
Ribavirin [USAN:INN]
Ribavirin [USAN:USP:INN:BAN]
Ribavirin Capsules
Ribavirin, 98%
Ribavirin, antiviral
Ribavirin, British Pharmacopoeia (BP) Reference Standard
Ribavirin, European Pharmacopoeia (EP) Reference Standard
Ribavirin, Pharmaceutical Secondary Standard; Certified Reference Material
Ribavirin, United States Pharmacopeia (USP) Reference Standard
Ribavirin,(S)
Ribavirina
Ribavirina [INN-Spanish]
Ribavirine
Ribavirine [INN-French]
Ribavirine;
Ribavirinum
Ribavirinum [INN-Latin]
ribofluranosyl carboxamide
Ribovirin
Ro 20-9963/000
Ro-20-9963
RTC
RTCA
s2504
SAM002548967
SBI-0051033.P003
SC-12159
SCH 18908
SCHEMBL3727
SMP1_000261
SMR000058315
Spectrum_001826
SPECTRUM1503938
Spectrum3_001876
Spectrum4_001252
Spectrum5_002075
SR-01000076112
SR-01000076112-11
SR-01000076112-2
SR-01000076112-3
SR-01000076112-4
SR-01000721904
SR-01000721904-2
ST2413783
Tox21_110259
Tox21_110259_1
Tox21_200967
Tox21_501063
Tribavirin
UNII-49717AWG6K
Varazid
Vilona
Viramid
Viramide
Virazid
Virazide
Virazole
Virazole (Ribavirin) Inhalation Solution
Virazole (TN)
Z1522567185
ZB015662
ZINC1035331

Paragraph IV (Patent) Challenges for RIBAVIRIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIRAZOLE	FOR SOLUTION;INHALATION	ribavirin	018859	2014-05-22
REBETOL	CAPSULE;ORAL	ribavirin	020903

US Patents and Regulatory Information for ribavirin

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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
Kadmon Pharms Llc	RIBAVIRIN	ribavirin	TABLET;ORAL	077456-001	Dec 5, 2005	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Roche	COPEGUS	ribavirin	TABLET;ORAL	021511-002	Jun 21, 2005		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sandoz	RIBAVIRIN	ribavirin	TABLET;ORAL	077743-001	Oct 3, 2006	AB	RX	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 ribavirin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	Start Trial	Start Trial
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	Start Trial	Start Trial
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ribavirin

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Country	Patent Number	Estimated Expiration
Japan	2005507931	Start Trial
Poland	205342	Start Trial
Denmark	1480653	Start Trial
>Country	>Patent Number	>Estimated Expiration

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