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Serving leading biopharmaceutical companies globally:

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Teva
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Generated: October 21, 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-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-nine 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. Sixty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: oxycodone hydrochloride

US Patents:27
Tradenames:5
Applicants:29
NDAs:44
Drug Master File Entries: see list17
Suppliers / Packagers: see list60
Bulk Api Vendors: see list24
Clinical Trials: see list2,565
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
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
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Lannett Holdings Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL204085-001Sep 9, 2014AARXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Egalet Us Inc
OXAYDO
oxycodone hydrochloride
TABLET;ORAL202080-002Jun 17, 2011RXNoNo► Subscribe► SubscribeY ► Subscribe
Wes Pharma Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL209897-001Sep 6, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010RXYesNo► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010RXYesNo► 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 Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 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;ORAL022272-002Apr 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;ORAL022272-005Apr 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;ORAL022272-002Apr 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;ORAL022272-004Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-006Apr 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
7,144,587Pharmaceutical formulation containing opioid agonist, opioid antagonist and bittering agent► Subscribe
8,323,889Process for the production of an abuse-proofed solid dosage form► Subscribe
8,524,275Pharmaceutical formulations containing opioid agonist, opioid antagonist and gelling agent► Subscribe
9,511,065Pharmaceutical formulation containing irritant► Subscribe
9,737,529Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant agent► Subscribe
9,486,412Tamper resistant dosage forms► Subscribe
9,095,615Tamper resistant dosage forms► Subscribe
8,529,948Pharmaceutical formulation containing gelling agent► Subscribe
9,084,816Tamper resistant dosage forms► Subscribe
9,492,390Tamper 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
South Korea20150082669► Subscribe
Mexico2009002023► Subscribe
BrazilPI0606145► Subscribe
TaiwanI341213► Subscribe
China105267170► Subscribe
Cyprus1113141► Subscribe
CroatiaP20130539► Subscribe
CroatiaP20160223► Subscribe
Slovenia2080514► Subscribe
China102838607► 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 leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Daiichi Sankyo
Healthtrust
QuintilesIMS
McKinsey
Covington
AstraZeneca
Express Scripts
US Department of Justice

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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