OXYMORPHONE HYDROCHLORIDE Drug Patent Profile
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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. Ten 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.
Summary for OXYMORPHONE HYDROCHLORIDE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Ltd | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203506-006 | Apr 24, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Specgx Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202946-004 | Jun 27, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Epic Pharma Llc | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 201187-001 | Dec 15, 2014 | AB | RX | 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 |