Oxycodone hydrochloride - Generic Drug Details
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What are the generic sources for oxycodone hydrochloride and what is the scope of freedom to operate?
Oxycodone hydrochloride
is the generic ingredient in five branded drugs marketed by 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, Pharmobedient Cnsltg, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Wes Pharma 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-two NDAs. There are twenty 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 eight patent family members in forty-eight countries.
There are twelve drug master file entries for oxycodone hydrochloride. Forty-two suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone hydrochloride
International Patents: | 408 |
US Patents: | 20 |
Tradenames: | 5 |
Applicants: | 31 |
NDAs: | 52 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 28 |
Clinical Trials: | 563 |
Patent Applications: | 3,105 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxycodone hydrochloride |
What excipients (inactive ingredients) are in oxycodone hydrochloride? | oxycodone hydrochloride excipients list |
DailyMed Link: | oxycodone hydrochloride at DailyMed |
Recent Clinical Trials for oxycodone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Center for Complementary and Integrative Health (NCCIH) | Early Phase 1 |
Washington State University | Early Phase 1 |
University of Miami | Phase 2 |
Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 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 hydrochloride
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OXAYDO | Tablets | oxycodone hydrochloride | 5 mg and 7.5 mg | 202080 | 1 | 2012-02-07 |
OXYCONTIN | Extended-release Tablets | oxycodone hydrochloride | 20 mg | 022272 | 2 | 2010-10-29 |
OXYCONTIN | Extended-release Tablets | oxycodone hydrochloride | 15 mg | 022272 | 1 | 2010-10-28 |
OXYCONTIN | Extended-release Tablets | oxycodone hydrochloride | 10 mg | 022272 | 1 | 2010-10-25 |
OXYCONTIN | Extended-release Tablets | oxycodone hydrochloride | 30 mg, 60 mg and 80 mg | 022272 | 1 | 2010-10-18 |
OXYCONTIN | Extended-release Tablets | oxycodone hydrochloride | 40 mg | 022272 | 1 | 2010-10-04 |
US Patents and Regulatory Information for oxycodone hydrochloride
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 | 022272-002 | Apr 5, 2010 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Specgx Llc | ROXICODONE | oxycodone hydrochloride | TABLET;ORAL | 021011-001 | Aug 31, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Dr Reddys Labs Sa | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 091313-005 | Apr 29, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxycodone hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2017239544 | Methods and compositions for deterring abuse of opioid containing dosage forms | ⤷ Try a Trial |
China | 101812065 | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone | ⤷ Try a Trial |
Japan | 5980881 | ⤷ Try a Trial | |
Australia | 2013202453 | Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for oxycodone hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1685839 | 92292 | Luxembourg | ⤷ Try a Trial | 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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