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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cerilliant
Citi
Cantor Fitzgerald
Cipla
Argus Health
Mallinckrodt
Dow
McKinsey
Merck
Fish and Richardson

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020049

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NDA 020049 describes PENTASA, which is a drug marketed by Shire and is included in one NDA. It is available from five suppliers. Additional details are available on the PENTASA profile page.

The generic ingredient in PENTASA is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 020049

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020049

Ingredient-typeAminosalicylic Acids

Medical Subject Heading (MeSH) Categories for 020049

Suppliers and Packaging for NDA: 020049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-189 54092-189-81 240 CAPSULE in 1 BOTTLE (54092-189-81)
PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-191 54092-191-12 120 CAPSULE in 1 BOTTLE (54092-191-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength250MG
Approval Date:May 10, 1993TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 8, 2004TE:RLD:Yes

Expired Orange Book Patents for NDA: 020049

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Covington
Farmers Insurance
Healthtrust
McKesson
Johnson and Johnson
AstraZeneca
Deloitte
Express Scripts
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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