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Generated: December 16, 2017

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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 Ani Pharms Inc, Avanthi Inc, Lannett Holdings Inc, Lehigh Valley, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Egalet Us Inc, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, and Daiichi Sankyo Inc, and is included in forty-five NDAs. There are twenty-seven 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 sixty-six patent family members in forty-seven countries and one supplementary protection certificate in one country.

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.

Pharmacology for oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe80MGTABLET, EXTENDED RELEASE; ORAL
u► Subscribe80MGTABLET, EXTENDED RELEASE; ORAL
u► 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
Nesher PharmsOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideTABLET;ORAL077290-005Dec 8, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Egalet Us IncOXAYDOoxycodone hydrochlorideTABLET;ORAL202080-001Jun 17, 2011RXNoNo► Subscribe► SubscribeY► Subscribe
Avanthi IncOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideTABLET;ORAL091393-005Aug 31, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Abhai LlcOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideSOLUTION;ORAL208593-002Jul 21, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Ani Pharms IncOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideSOLUTION;ORAL204979-001Jun 1, 2015AARXNoNo► Subscribe► Subscribe► Subscribe
Abhai LlcOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideSOLUTION;ORAL208593-001Jul 21, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Novel Labs IncOXYCODONE HYDROCHLORIDEoxycodone hydrochlorideCAPSULE;ORAL204752-001Aug 24, 2015ABRXNoNo► Subscribe► Subscribe► 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 LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-005Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma LpOXYCONTINoxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022272-007Apr 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
9,095,615Tamper resistant dosage forms► Subscribe
9,084,816Tamper resistant dosage forms► Subscribe
8,529,948Pharmaceutical formulation containing gelling agent► Subscribe
9,486,412Tamper resistant dosage forms► Subscribe
8,846,086Tamper resistant dosage forms► Subscribe
9,775,811Tamper resistant dosage forms► Subscribe
9,737,529Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent► Subscribe
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
8,815,289Tamper resistant dosage forms► Subscribe
7,157,103Pharmaceutical formulation containing irritant► 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
Russian Federation2399371► Subscribe
European Patent Office1414418► Subscribe
Spain2357376► Subscribe
Hungary0401195► Subscribe
Israel241122► Subscribe
South Korea20140049085► Subscribe
European Patent Office2399580► Subscribe
Portugal1658054► Subscribe
Japan2007516998► Subscribe
BrazilPI0606145► 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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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
US Army
Novartis
McKinsey
Deloitte
Accenture
Argus Health
McKesson
Farmers Insurance

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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