OXYMORPHONE HYDROCHLORIDE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Oxymorphone Hydrochloride, and what generic alternatives are available?
Oxymorphone Hydrochloride is a drug marketed by 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 thirteen NDAs.
The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Oxymorphone Hydrochloride
A generic version of OXYMORPHONE HYDROCHLORIDE was approved as oxymorphone hydrochloride by IMPAX LABS on June 14th, 2010.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for OXYMORPHONE HYDROCHLORIDE?
- What are the global sales for OXYMORPHONE HYDROCHLORIDE?
- What is Average Wholesale Price for OXYMORPHONE HYDROCHLORIDE?
Summary for OXYMORPHONE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 12 |
| Clinical Trials: | 37 |
| Patent Applications: | 850 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXYMORPHONE HYDROCHLORIDE |
| 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 |
| Shirley Ryan AbilityLab | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Ltd | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203506-006 | Apr 24, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202946-004 | Jun 27, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Epic Pharma Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 201187-001 | Dec 15, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurolife Pharma Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 204459-001 | Apr 26, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Epic Pharma Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 201187-002 | Dec 15, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 091443-002 | Feb 15, 2011 | 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 |
