OXYMORPHONE HYDROCHLORIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for oxymorphone hydrochloride and what is the scope of freedom to operate?
Oxymorphone hydrochloride
is the generic ingredient in four branded drugs marketed by Endo Pharms, Endo Operations, Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in eighteen NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Oxymorphone hydrochloride has two hundred and four patent family members in thirty-two countries.
There are seven drug master file entries for oxymorphone hydrochloride. Nine suppliers are listed for this compound.
Summary for OXYMORPHONE HYDROCHLORIDE
International Patents: | 204 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 13 |
NDAs: | 18 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 12 |
Clinical Trials: | 37 |
Patent Applications: | 1,176 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXYMORPHONE HYDROCHLORIDE |
What excipients (inactive ingredients) are in OXYMORPHONE HYDROCHLORIDE? | OXYMORPHONE HYDROCHLORIDE excipients list |
DailyMed Link: | OXYMORPHONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for OXYMORPHONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 4 |
Kaohsiung Medical University Chung-Ho Memorial Hospital | Phase 4 |
National Institutes of Health (NIH) | Phase 2 |
Pharmacology for OXYMORPHONE HYDROCHLORIDE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for OXYMORPHONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for OXYMORPHONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for OXYMORPHONE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
OPANA ER | Extended-release Tablets | oxymorphone hydrochloride | 20 mg, 30 mg and 40 mg | 201655 | 1 | 2012-04-03 |
OPANA ER | Extended-release Tablets | oxymorphone hydrochloride | 5 mg | 201655 | 1 | 2012-03-26 |
OPANA ER | Extended-release Tablets | oxymorphone hydrochloride | 7.5 mg, 10 mg, and 15 mg | 201655 | 1 | 2012-03-23 |
US Patents and Regulatory Information for OXYMORPHONE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Pharms | OPANA | oxymorphone hydrochloride | TABLET;ORAL | 021611-002 | Jun 22, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Operations | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610-007 | Feb 29, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-006 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Avanthi Inc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 203601-001 | Jan 30, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 OXYMORPHONE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-006 | Dec 9, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-002 | Dec 9, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Endo Operations | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610-005 | Feb 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-002 | Dec 9, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OXYMORPHONE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1658054 | FORME DE PREPARATION SECURISEE CONTRE UN EMPLOI ABUSIF (DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE) | ⤷ Sign Up |
Mexico | 337864 | METODO MEJORADO PARA PRODUCIR ANALGESICOS. (IMPROVED METHOD FOR MAKING ANALGESICS.) | ⤷ Sign Up |
Spain | 2393787 | ⤷ Sign Up | |
Denmark | 1658055 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.