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Last Updated: March 19, 2024

EXALGO Drug Patent Profile


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

Exalgo is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for EXALGO
Drug patent expirations by year for EXALGO
Drug Prices for EXALGO

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Drug Sales Revenue Trends for EXALGO

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Recent Clinical Trials for EXALGO

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

SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterPhase 3

See all EXALGO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for EXALGO
Paragraph IV (Patent) Challenges for EXALGO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXALGO Extended-release Tablets hydromorphone hydrochloride 8 mg and 12 mg 021217 1 2010-09-02
EXALGO Extended-release Tablets hydromorphone hydrochloride 16 mg 021217 1 2010-08-02

US Patents and Regulatory Information for EXALGO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 EXALGO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EXALGO

See the table below for patents covering EXALGO around the world.

Country Patent Number Title Estimated Expiration
Denmark 0769949 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9601629 ⤷  Try a Trial
Germany 69529412 ⤷  Try a Trial
Denmark 1025845 ⤷  Try a Trial
Austria 230992 ⤷  Try a Trial
New Zealand 289289 HYDROMORPHONE (4,5-EPOXY-3-HYDROXY-17-METHYLMORPHINAN-6-ONE) COMPOSITIONS AND USE THEREOF ⤷  Try a Trial
Spain 2186724 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.