Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Covington
Harvard Business School
Teva
Healthtrust
Julphar
Fuji
Cipla
UBS

Generated: May 20, 2018

DrugPatentWatch Database Preview

OPANA Drug Profile

or, see our see our flat-rate plans

« Back to Dashboard

Which patents cover Opana, and when can generic versions of Opana launch?

Opana is a drug marketed by Endo Pharms and is included in four NDAs. There are ten patents protecting this drug and six Paragraph IV challenges.

The generic ingredient in OPANA is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Drug patent expirations by year for OPANA
Pharmacology for OPANA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for OPANA
Synonyms for OPANA
(-)-Oxymorphone
(14S)-14-Hydroxydihydromorphinone
(1S,5R,13R,17S)-10,17-dihydroxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10-trien-14-one
(1S,5R,13R,17S)-10,17-DIHYDROXY-4-METHYL-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7(18),8,10-TRIEN-14-ONE
(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one
(5alpha)-3,14-dihydroxy-17-methyl-4,5-epoxymorphinan-6-one
(5alpha)-4,5-Epoxy-3,14-dihydroxyl-17-methylmorphinan-6-one
10,17-dihydroxy-4-methyl-(13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
10,17-dihydroxy-4-methyl-(13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one(oxymorphone)
10,17-dihydroxy-4-methyl-(13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one(xymorphone)
10,17-dihydroxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7,9,11(18)-trien-14-one
14-Hydroxydihydromorphinone
3,14-Dihydroxy-4,5-alpha-epoxy-17-methylmorphinan-6-one
357-07-3 (hydrochloride)
4,5-Epoxy-3,14-dihydroxy-N-methyl-6-oxomorphinan
4,5alpha-Epoxy-3,14-dihydroxy-17-methyl morphinan-6-one
7,8-Dihydro-14-hydroxymorphinone
76-41-5
9VXA968E0C
AKOS015962232
API0003722
BDBM50001707
BRN 0041588
C-18811
C08019
CC-33434
CHEBI:7865
CHEMBL963
CS-2852
D02NSF
D08323
DB01192
DEA No. 9652
Dihydro-14-hydroxymorphinone
Dihydrohydroxymorphinone
Dihydroxymorphinone
DTXSID5023409
EINECS 200-959-7
EN3202
FT-0080194
GTPL7094
HSDB 8060
HY-B0618
Morphinan-6-one, 3,14-dihydroxy-4,5-alpha-epoxy-17-methyl-
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, (5-alpha)- (9CI)
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, (5alpha)-
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, (5alpha)- (9CI)
Morphinan-6-one, 4,5alpha-epoxy-3,14-dihydroxy-17-methyl- (8CI)
Morphinan-6-one,5-epoxy-3,14-dihydroxy-17-methyl-, (5.alpha.)-
Morphinan-6-one,5.alpha.-epoxy-3,14-dihydroxy-17-methyl-
Morphinone, 7,8-dihydro-14-hydroxy- (6CI,7CI)
Morphinone, dihydro-14-hydroxy-
NIH10323
NSC 19045
NSC-19045
NSC19045
Numorphan
Numorphone
Ossimorfone
Ossimorfone [DCIT]
Oximorfona
Oximorfona [INN-Spanish]
Oximorphonum
Oxymorphine
oxymorphone
Oxymorphone (abuse-resistant, pain)
Oxymorphone (abuse-resistant, pain), Pain Therapeutics/ King Pharmaceuticals
Oxymorphone (abuse-resistant, pain), Pain Therapeutics/Pfizer
Oxymorphone (INN)
Oxymorphone [INN:BAN]
Oxymorphone 0.1 mg/ml in Methanol
Oxymorphone 1.0 mg/ml in Methanol
Oxymorphone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Oxymorphonum
Oxymorphonum [INN-Latin]
PL005498
SCHEMBL3571
UNII-9VXA968E0C
UQCNKQCJZOAFTQ-ISWURRPUSA-N
ZINC3875483

US Patents and Regulatory Information for OPANA

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 201655-007 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-003 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Paragraph IV (Patent) Challenges for OPANA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg, 10 mg, and 15 mg ➤ Subscribe 2012-03-23
➤ Subscribe Extended-release Tablets 5 mg ➤ Subscribe 2012-03-26
➤ Subscribe Extended-release Tablets 20 mg, 30 mg, 40 mg ➤ Subscribe 2012-04-03
➤ Subscribe Extended-release Tablets 30 mg ➤ Subscribe 2008-06-12
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe 2008-05-29
➤ Subscribe Extended-release Tablets 5 mg, 10 mg, 20 mg and 40 mg ➤ Subscribe 2007-11-23

or, see our see our flat-rate plans

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Farmers Insurance
Accenture
Express Scripts
Queensland Health
Cerilliant
Medtronic
Colorcon

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 verifification 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.