.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Analyze global market entry opportunities
  • Drug patents and clinical trials in dozens of countries

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Oxycodone hydrochloride - Generic Drug Details

« Back to Dashboard

What are the generic drug sources, and freedom to operate, for oxycodone hydrochloride?

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

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

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

Summary for Generic Name: oxycodone hydrochloride

Tradenames:4
Patents:23
Applicants:25
NDAs:35
Drug Master File Entries: see list17
Suppliers / Packagers: see list57
Bulk Api Vendors: see list24
Clinical Trials: see list1,102
Patent Applications: see list6,229
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. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL10MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL20MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXYesNo9,492,393► Subscribe ► Subscribe
Lehigh Valley
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL200535-002Aug 22, 2013RXYesNo► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 2010RXYesNo9,060,976► SubscribeY ► Subscribe
Rhodes Pharms
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL091490-003Mar 9, 2011RXNoNo► Subscribe► Subscribe
Nesher Pharms
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL077290-002Dec 8, 2005RXNoNo► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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;ORAL022272-007Apr 5, 20105,508,042► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 20105,508,042► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 20105,508,042► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 20105,508,042► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-002Apr 5, 20105,508,042► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
7,157,103Pharmaceutical formulation containing irritant► Subscribe
9,486,412Tamper resistant dosage forms► Subscribe
9,511,065Pharmaceutical formulation containing irritant► Subscribe
7,727,557Pharmaceutical formulation containing irritant► Subscribe
9,387,174Pharmaceutical formulation containing gelling agent► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: oxycodone hydrochloride

Country Document Number Estimated Expiration
Eurasian Patent Organization013208► Subscribe
Hong Kong1154491► Subscribe
Peru03402015► Subscribe
Portugal1740156► Subscribe
European Patent Office2478896► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc