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Generated: December 10, 2018

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XEPI Drug Profile

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When do Xepi patents expire, and what generic alternatives are available?

Xepi is a drug marketed by Ferrer Internacional and is included in one NDA. There are three patents protecting this drug.

This drug has forty-seven patent family members in twenty-three countries.

The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ozenoxacin profile page.

Summary for XEPI
International Patents:47
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 14
Patent Applications: 9
DailyMed Link:XEPI at DailyMed
Drug patent expirations by year for XEPI
Generic Entry Opportunity Date for XEPI
Generic Entry Date for XEPI*:
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.

Synonyms for XEPI
1-cyclopropyl-1,4-dihydro-8-methyl-7-[5-methyl-6-(methylamino)-3-pyridinyl]-4-oxo-3-Quinolinecarboxylic acid
1-cyclopropyl-8-methyl-7-(5-methyl-6-(methylamino)pyridin-3-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
245765-41-7
AKOS032947315
CHEBI:136050
CS-0003657
D09544
DB12924
FT-0701296
HY-14957
KB-80783
Ozenoxacin
Ozenoxacin (JAN/INN)
Ozenoxacin [INN:JAN]
Ozenoxacin Cream
SCHEMBL1711829
T 3912
T-3912
UNII-V0LH498RFO
V0LH498RFO
zebiax
ZINC1483896

US Patents and Regulatory Information for XEPI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for XEPI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017000073 Germany ➤ Sign Up PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517
0884 Netherlands ➤ Sign Up PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Cantor Fitzgerald
Colorcon
Chinese Patent Office
Merck
Boehringer Ingelheim
Farmers Insurance
AstraZeneca

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