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Serving leading biopharmaceutical companies globally:

Cipla
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Express Scripts
Harvard Business School
Teva
Johnson and Johnson
Daiichi Sankyo
Colorcon
Baxter
Mallinckrodt

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020903

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NDA 020903 describes REBETOL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the REBETOL profile page.

The generic ingredient in REBETOL is ribavirin. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

Summary for 020903

Tradename:1
Applicant:1
Ingredient:1
Patents:5
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020903

Ingredient-typeNucleoside Analog

Medical Subject Heading (MeSH) Categories for 020903

Suppliers and Packaging for NDA: 020903

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REBETOL ribavirin CAPSULE;ORAL 020903 NDA Merck Sharp & Dohme Corp. 0085-1194 0085-1194-03 84 CAPSULE in 1 BOTTLE (0085-1194-03)
REBETOL ribavirin CAPSULE;ORAL 020903 NDA Merck Sharp & Dohme Corp. 0085-1351 0085-1351-05 56 CAPSULE in 1 BOTTLE (0085-1351-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
Approval Date:Jun 3, 1998TE:RLD:No
Patent:► SubscribePatent Expiration:Mar 21, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:May 1, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:May 1, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020903

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-002Jul 25, 2001► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
Merck Sharp DohmeREBETOLribavirinCAPSULE;ORAL020903-001Jun 3, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Cerilliant
US Department of Justice
Novartis
Cipla
Federal Trade Commission
Deloitte
UBS
Moodys

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