opana er Drug Patent Profile
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Which patents cover Opana Er, and what generic alternatives are available?
Opana Er is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are five patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and four patent family members in thirty-two countries.
The generic ingredient in OPANA ER 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 Opana Er
A generic version of opana er was approved as oxymorphone hydrochloride by IMPAX LABS on June 14th, 2010.
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Summary for opana er
International Patents: | 204 |
US Patents: | 5 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 11 |
Patent Applications: | 850 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for opana er |
What excipients (inactive ingredients) are in opana er? | opana er excipients list |
DailyMed Link: | opana er at DailyMed |
Paragraph IV (Patent) Challenges for OPANA ER
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 opana er
opana er is protected by six US patents.
Patents protecting opana er
Method for making analgesics
Patent Number: ⤷ Sign Up
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Abuse-proofed dosage form
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Abuse-proof dosage form
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Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
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Patented Use: DOSE MODIFICATION FOR RENAL IMPAIRMENT
Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
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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 ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-006 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-004 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-007 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-007 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-003 | Dec 9, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-004 | Dec 9, 2011 | DISCN | Yes | No | ⤷ 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 opana er
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Endo Operations | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610-003 | Jun 22, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-005 | Dec 9, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Endo Operations | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610-004 | Jun 22, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Endo Operations | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610-002 | Jun 22, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-004 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for opana er
See the table below for patents covering opana er around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | E448231 | ⤷ Sign Up | |
Austria | 507820 | ⤷ Sign Up | |
Spain | 2629303 | ⤷ Sign Up | |
European Patent Office | 1765298 | PROCEDE DE PRODUCTION D'UNE FORME POSOLOGIQUE SOLIDE ANTI-ABUS AU MOYEN D'UNE EXTRUDEUSE A VIS PLANETAIRES (METHOD FOR PRODUCING A SOLID DOSAGE FORM, WHICH IS SAFEGUARDED AGAINST ABUSE, WHILE USING A PLANETARY GEAR EXTRUDER) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006002883 | ⤷ Sign Up | |
Israel | 126595 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |