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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Mallinckrodt
Teva
Moodys
Express Scripts
Colorcon
Johnson and Johnson
Novartis
US Department of Justice
Federal Trade Commission

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021260

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NDA 021260 describes AVINZA, which is a drug marketed by King Pharms Llc and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AVINZA profile page.

The generic ingredient in AVINZA is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 021260

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

Pharmacology for NDA: 021260

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 021260

Suppliers and Packaging for NDA: 021260

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260 NDA STAT RX USA LLC 16590-593 16590-593-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-593-90)
AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260 NDA STAT RX USA LLC 16590-593 16590-593-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-593-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Mar 20, 2002TE:RLD:No
Patent:► SubscribePatent Expiration:Nov 25, 2017Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Mar 20, 2002TE:RLD:No
Patent:► SubscribePatent Expiration:Nov 25, 2017Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Mar 20, 2002TE:RLD:No
Patent:► SubscribePatent Expiration:Nov 25, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021260

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-001Mar 20, 2002► Subscribe► Subscribe
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-006Dec 18, 2008► Subscribe► Subscribe
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-004Mar 20, 2002► Subscribe► Subscribe
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-005Dec 18, 2008► Subscribe► Subscribe
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-003Mar 20, 2002► Subscribe► Subscribe
King Pharms LlcAVINZAmorphine sulfateCAPSULE, EXTENDED RELEASE;ORAL021260-002Mar 20, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Harvard Business School
Argus Health
Cerilliant
UBS
Cantor Fitzgerald
Federal Trade Commission
Moodys
Chubb

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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