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XERESE Drug Profile
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Which patents cover Xerese, and when can generic versions of Xerese launch?
Xerese is a drug marketed by Bausch and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-five patent family members in twenty-one countries.
The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acyclovir; hydrocortisone profile page.
US ANDA Litigation and Generic Entry Outlook for Xerese
Xerese was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 13, 2022. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XERESE
| International Patents: | 25 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XERESE |
| DailyMed Link: | XERESE at DailyMed |
Generic Entry Opportunity Date for XERESE
Generic Entry Date for XERESE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL |
*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 XERESE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Meda Pharmaceuticals | Phase 3 |
| TKL Research, Inc. | Phase 3 |
Pharmacology for XERESE
US Patents and Regulatory Information for XERESE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | XERESE | acyclovir; hydrocortisone | CREAM;TOPICAL | 022436-001 | Jul 31, 2009 | 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 |
Expired US Patents for XERESE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | XERESE | acyclovir; hydrocortisone | CREAM;TOPICAL | 022436-001 | Jul 31, 2009 | Start Trial | Start Trial |
| Bausch | XERESE | acyclovir; hydrocortisone | CREAM;TOPICAL | 022436-001 | Jul 31, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XERESE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Sweden | 9803929 | Start Trial |
| Japan | 5420583 | Start Trial |
| Denmark | 1131104 | Start Trial |
| Israel | 142702 | Start Trial |
| New Zealand | 511832 | Start Trial |
| Australia | 1436400 | Start Trial |
| Taiwan | 589191 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
