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Last Updated: April 4, 2020

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XTAMPZA ER Drug Profile


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

Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.

US ANDA Litigation and Generic Entry Outlook for Xtampza Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2036. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (oxycodone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XTAMPZA ER
Drug Prices for XTAMPZA ER

See drug prices for XTAMPZA ER

Generic Entry Opportunity Date for XTAMPZA ER
Generic Entry Date for XTAMPZA ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XTAMPZA ER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ajay Wasan, MD, MscPhase 4
University of Alabama at BirminghamEarly Phase 1

See all XTAMPZA ER clinical trials

Recent Litigation for XTAMPZA ER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc.2018-02-22
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Cornerstone Biopharma Inc. v. Exela Pharma Sciences LLC2013-07-24

See all XTAMPZA ER litigation

Pharmacology for XTAMPZA ER
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for XTAMPZA ER
(-)-14-Hydroxydihydrocodeinone
(-)-Oxycodone
(1S,5R,13R,17S)-17-hydroxy-10-methoxy-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
(4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one
(5alpha)-14-hydroxy-17-methyl-3-(methyloxy)-4,5-epoxymorphinan-6-one
(5alpha)-14-Hydroxy-3-methoxy-17-methyl-4,5-epoxymorphinan-6-one
14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one
14-Hydroxydihydrocodeinone
4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
4,5.alpha.-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
4,5alpha-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
4aH-8,5-bcd]furan-5(6H)-one, 7,7a,8,9-tetrahydro-7a-hydroxy-3-methoxy-12-methyl-
76-42-6
AC-16043
Apo-oxycodone CR
Avridi
BDBM50370595
BRN 0043446
BRUQQQPBMZOVGD-XFKAJCMBSA-N
C08018
CD35PMG570
CHEBI:7852
CHEMBL656
Codeinone, 7,8-dihydro-14-hydroxy-
Codeinone, dihydro-14-hydroxy-
Codeinone, dihydrohydroxy-
Codeinone,8-dihydro-14-hydroxy-
D05312
DB00497
DEA No. 9143
Dihydro-14-hydroxycodeinone
Dihydrohydroxycodeinone
Dihydrohydroxycondeinone
Dihydrone
Dihydroxycodeinone
Diphydrone
DTXSID5023407
EINECS 200-960-2
Endine (Australia)
Endone
Eubine [France]
Eucodalum
GTPL7093
HSDB 3142
Hydroxycodeinon
IDS-NO-002
LS-92148
Morphinan-6-one, 4,5-alpha-epoxy-14-hydroxy-3-methoxy-17-methyl-
Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5alpha)-
Morphinan-6-one, 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methyl-
Morphinan-6-one, 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methyl- (8CI)
Morphinan-6-one,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5.alpha.)-
Morphinan-6-one,5.alpha.-epoxy-14-hydroxy-3-methoxy-17-methyl-
N02AA05
NSC 19043
NSC-19043
NSC19043
Ossicodone
Ossicodone [DCIT]
Oxanest
Oxicodona
Oxicodona [INN-Spanish]
Oxicon
Oxicone
Oxiconum
Oxycodeinon
Oxycodeinone
Oxycodon
oxycodone
Oxycodone (USAN/INN)
Oxycodone [USAN:INN:BAN]
Oxycodone 0.1 mg/ml in Methanol
Oxycodone 1.0 mg/ml in Methanol
Oxycodone cii
Oxycodone Concentrate
Oxycodone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Oxycodonum
Oxycodonum [INN-Latin]
Oxycone
Oxycontin
Oxyfast
OxyIR
Oxyneo
Pancodine
Pancodone Retard
Pancodone retard (United Kingdom)
Percobarb
Percodan
PF-00345439
PF06
PTI-821
Q407535
Roxicodone
SCHEMBL2737
Supendol
Supendol [Canada]
Tekodin (free base)
Theocodin
UNII-CD35PMG570
WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ CQ JO1 P1
Xtampza
ZINC403533
Paragraph IV (Patent) Challenges for XTAMPZA ER
Tradename Dosage Ingredient NDA Submissiondate
XTAMPZA ER CAPSULE, EXTENDED RELEASE;ORAL oxycodone 208090 2017-11-15

US Patents and Regulatory Information for XTAMPZA ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-004 Apr 26, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XTAMPZA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Boehringer Ingelheim
Baxter
McKesson
Dow

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.