opana er Drug Patent Profile
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Which patents cover Opana Er, and when can generic versions of Opana Er launch?
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
Patent Expiration: ⤷ Sign Up
Abuse-proofed dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Abuse-proof dosage form
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Patent Expiration: ⤷ Sign Up
Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DOSE MODIFICATION FOR RENAL IMPAIRMENT
Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Patent Number: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
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 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 |
Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-001 | 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 |
>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 |
---|---|---|---|
Israel | 143642 | ⤷ Sign Up | |
Russian Federation | 2010119291 | СТОЙКАЯ К РАЗРУШЕНИЮ ЛЕКАРСТВЕННАЯ ФОРМА С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ОКСИКОДОНА ГИДРОХЛОРИДА | ⤷ Sign Up |
Brazil | PI0413361 | forma de dosagem protegida contra abusos | ⤷ Sign Up |
Norway | 338235 | ⤷ Sign Up | |
Mexico | 9204352 | TABLETAS DE VERAPAMIL DE LIBERACION CONTROLADA | ⤷ Sign Up |
European Patent Office | 2478896 | Formes pharmaceutiques résistantes à la rupture avec libération prolongée (Fracture-resistant application forms with delayed release) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |