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. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Exalgo
A generic version of EXALGO was approved as hydromorphone hydrochloride by HIKMA on July 29th, 1998.
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Summary for EXALGO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| Clinical Trials: | 8 |
| Patent Applications: | 1,901 |
| Drug Prices: | Drug price information for EXALGO |
| What excipients (inactive ingredients) are in EXALGO? | EXALGO excipients list |
| DailyMed Link: | EXALGO at DailyMed |
Recent Clinical Trials for EXALGO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Early Phase 1 |
| M.D. Anderson Cancer Center | Early Phase 1 |
| M.D. Anderson Cancer Center | Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-004 | Aug 24, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-002 | Mar 1, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-003 | Mar 1, 2010 | DISCN | Yes | 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 |
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 | 021217-001 | Mar 1, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-002 | Mar 1, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-003 | Mar 1, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-004 | Aug 24, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-004 | Aug 24, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | EXALGO | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217-003 | Mar 1, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | ⤷ Sign Up | |
| Germany | 69528852 | ⤷ Sign Up | |
| Germany | 69529412 | ⤷ Sign Up | |
| Austria | 230992 | ⤷ Sign Up | |
| New Zealand | 289289 | HYDROMORPHONE (4,5-EPOXY-3-HYDROXY-17-METHYLMORPHINAN-6-ONE) COMPOSITIONS AND USE THEREOF | ⤷ Sign Up |
| South Africa | 9505674 | ⤷ Sign Up | |
| >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.
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