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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Teva
Healthtrust
Julphar
Colorcon
Cantor Fitzgerald
Queensland Health
Express Scripts
Merck

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021610

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NDA 021610 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. It is available from six suppliers. There are ten patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA ER profile page.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 021610

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

Pharmacology for NDA: 021610

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 021610

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021610 NDA STAT RX USA LLC 16590-609 16590-609-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-609-30)
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021610 NDA STAT RX USA LLC 16590-609 16590-609-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-609-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:► SubscribePatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:► SubscribePatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 22, 2006TE:RLD:No
Patent:► SubscribePatent Expiration:Feb 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE PAIN

Expired Orange Book Patents for NDA: 021610

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-006Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-006Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-001Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 2006► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Army
McKinsey
Fish and Richardson
AstraZeneca
Harvard Business School
Daiichi Sankyo
Boehringer Ingelheim
Argus Health
Covington
Citi

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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