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Serving 500+ biopharmaceutical companies globally:

Citi
McKinsey
Fuji
Teva
Queensland Health
Argus Health
Mallinckrodt
Chinese Patent Office
AstraZeneca
Farmers Insurance

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021110

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NDA 021110 describes RAPAMUNE, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RAPAMUNE profile page.

The generic ingredient in RAPAMUNE is sirolimus. There are eighteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

Summary for NDA: 021110

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021110

Suppliers and Packaging for NDA: 021110

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAPAMUNE
sirolimus
TABLET;ORAL 021110 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1040 0008-1040-05 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05)
RAPAMUNE
sirolimus
TABLET;ORAL 021110 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1040 0008-1040-10 100 BLISTER PACK in 1 CARTON (0008-1040-10) > 1 TABLET, SUGAR COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2000TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 11, 2018Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Sep 11, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021110

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002► Subscribe► Subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Julphar
AstraZeneca
Moodys
Boehringer Ingelheim
Daiichi Sankyo
Teva
Medtronic
Dow
US Army

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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