OXYCODONE - Generic Drug Details
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What are the generic sources for oxycodone and what is the scope of freedom to operate?
Oxycodone
is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-three NDAs. There are thirty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Oxycodone has twenty-four patent family members in thirteen countries.
There are nineteen drug master file entries for oxycodone. One supplier is listed for this compound. There are four tentative approvals for this compound.
Summary for OXYCODONE
International Patents: | 24 |
US Patents: | 33 |
Tradenames: | 6 |
Applicants: | 33 |
NDAs: | 53 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 575 |
Patent Applications: | 6,467 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for OXYCODONE |
Drug Sales Revenues: | Drug sales revenues for OXYCODONE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXYCODONE |
What excipients (inactive ingredients) are in OXYCODONE? | OXYCODONE excipients list |
DailyMed Link: | OXYCODONE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OXYCODONE
Generic Entry Date for OXYCODONE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for OXYCODONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Henry Ford Health System | Phase 4 |
University of Miami | Phase 3 |
Murdoch Childrens Research Institute | Phase 4 |
Generic filers with tentative approvals for OXYCODONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for OXYCODONE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for OXYCODONE
Anatomical Therapeutic Chemical (ATC) Classes for OXYCODONE
Paragraph IV (Patent) Challenges for OXYCODONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XTAMPZA ER | Extended-release Capsules | oxycodone | 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg | 208090 | 1 | 2017-11-15 |
US Patents and Regulatory Information for OXYCODONE
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;ORAL | 022272-001 | Apr 5, 2010 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Amneal Pharms | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 203638-005 | Jun 3, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-005 | Apr 26, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OXYCODONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-001 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-004 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-003 | Apr 26, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OXYCODONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4694207 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2004004693 | ⤷ Sign Up | |
Spain | 2653568 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OXYCODONE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1685839 | 92292 | Luxembourg | ⤷ Sign Up | PRODUCT 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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