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
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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 | |||
| >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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OPANA ER
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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.
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