TROXYCA ER Drug Patent Profile
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Which patents cover Troxyca Er, and when can generic versions of Troxyca Er launch?
Troxyca Er is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.
This drug has sixteen patent family members in twelve countries.
The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Troxyca Er
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 3, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for TROXYCA ER
| International Patents: | 16 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 5 |
| DailyMed Link: | TROXYCA ER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TROXYCA ER
*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.
US Patents and Regulatory Information for TROXYCA ER
TROXYCA ER is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TROXYCA ER is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TROXYCA ER
Sequestering subunit and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Sequestering subunit and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-001 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-004 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-002 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-006 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-004 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-001 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-002 | Aug 19, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for TROXYCA ER
See the table below for patents covering TROXYCA ER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 1551372 | ⤷ Sign Up | |
| Cyprus | 1120720 | ⤷ Sign Up | |
| European Patent Office | 2422775 | Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods) | ⤷ Sign Up |
| Hungary | E038446 | ⤷ Sign Up | |
| Australia | 2009251081 | Sequestering subunit and related compositions and methods | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004026283 | ⤷ Sign Up | |
| Spain | 2677769 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TROXYCA ER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2316456 | 132017000142109 | Italy | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
| 2316456 | 2017C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | 1790064-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330 |
| 2316456 | 17C1058 | France | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
| 2316456 | LUC00054 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
| 2316456 | SPC/GB17/078 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
| 2316456 | 2017/059 | Ireland | ⤷ Sign Up | PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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