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Accenture
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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020981

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NDA 020981 describes HYCAMTIN, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the HYCAMTIN profile page.

The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for NDA: 020981

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

Pharmacology for NDA: 020981

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 020981

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL 020981 NDA GlaxoSmithKline LLC 0007-4205 0007-4205-11 10 CAPSULE in 1 BOTTLE (0007-4205-11)
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL 020981 NDA GlaxoSmithKline LLC 0007-4207 0007-4207-11 10 CAPSULE in 1 BOTTLE (0007-4207-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.25MG BASE
Approval Date:Oct 11, 2007TE:RLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2024Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Oct 11, 2007TE:RLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020981

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL020981-001Oct 11, 2007► Subscribe► Subscribe
Novartis Pharms Corp
HYCAMTIN
topotecan hydrochloride
CAPSULE;ORAL020981-002Oct 11, 2007► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Julphar
Daiichi Sankyo
Argus Health
Fish and Richardson
Chubb
Farmers Insurance
Express Scripts
Teva
Colorcon
Merck

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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