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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Johnson and Johnson
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Oxycodone hydrochloride - Generic Drug Details

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What are the generic drug sources for oxycodone hydrochloride and what is the scope of oxycodone hydrochloride freedom to operate?

Oxycodone hydrochloride
is the generic ingredient in five branded drugs marketed by Novel Labs Inc, Mayne Pharma Inc, West-ward Pharms Int, Wes Pharma Inc, Mallinckrodt Inc, Vintage Pharms, Alvogen Malta, Hi-tech Pharmacal, Ascent Pharms Inc, Ken Lifescience, Pharm Assoc, Lannett Holdings Inc, Roxane, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Ani Pharms Inc, Wockhardt Bio Ag, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Purdue Pharma Lp, Avanthi Inc, Daiichi Sankyo Inc, Egalet Us Inc, Nesher Pharms, Rhodes Pharms, and Abhai Llc, and is included in forty-four NDAs. There are twenty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxycodone hydrochloride has five hundred and six patent family members in forty-seven countries.

There are seventeen drug master file entries for oxycodone hydrochloride. Fifty-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: oxycodone hydrochloride

Tradenames:5
Patents:24
Applicants:29
NDAs:44
Drug Master File Entries: see list17
Suppliers / Packagers: see list59
Bulk Api Vendors: see list24
Clinical Trials: see list2,554
Patent Applications: see list6,391
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxycodone hydrochloride at DailyMed

Pharmacology for Ingredient: oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe80MGTABLET, EXTENDED RELEASE; ORAL
► Subscribe► Subscribe80MGTABLET, EXTENDED RELEASE; ORAL
► Subscribe► Subscribe40MGTABLET, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc
ROXICODONE
oxycodone hydrochloride
TABLET;ORAL021011-001Aug 31, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-005Apr 5, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Egalet Us Inc
OXAYDO
oxycodone hydrochloride
TABLET;ORAL202080-002Jun 17, 2011RXNoNo► Subscribe► SubscribeY ► Subscribe
Actavis Elizabeth
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL076636-003Apr 7, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
West-ward Pharms Int
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL204037-001Jul 15, 2013AARXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-005Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-005Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: oxycodone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,337,888Pharmaceutical formulation containing gelling agent► Subscribe
8,017,148Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent► Subscribe
8,192,722Abuse-proof dosage form► Subscribe
9,387,174Pharmaceutical formulation containing gelling agent► Subscribe
9,561,225Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent► Subscribe
8,652,515Pharmaceutical formulation containing an opioid agonist, opioid antagonist and irritant agent► Subscribe
9,040,084Pharmaceutical formulation containing gelling agent► Subscribe
9,492,390Tamper resistant dosage forms► Subscribe
9,757,341Pharmaceutical formulation containing gelling agent► Subscribe
8,911,719Tamper resistant dosage forms► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: oxycodone hydrochloride

Country Document Number Estimated Expiration
Japan2005534664► Subscribe
European Patent Office1014941► Subscribe
Cyprus1114104► Subscribe
Japan2017125052► Subscribe
Australia2015200009► Subscribe
China1960994► Subscribe
SloveniaEP2305683► Subscribe
Germany502004010368► Subscribe
Portugal2311459► Subscribe
Japan2012229249► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OXYCODONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292Luxembourg► SubscribePRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Cerilliant
Johnson and Johnson
Julphar
McKesson
QuintilesIMS
Novartis
Colorcon
Federal Trade Commission
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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