INLEXZO Drug Patent Profile
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When do Inlexzo patents expire, and what generic alternatives are available?
Inlexzo is a drug marketed by Janssen Biotech and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and sixty-five patent family members in thirty-three countries.
The generic ingredient in INLEXZO is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Inlexzo
A generic version of INLEXZO was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.
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Summary for INLEXZO
| International Patents: | 165 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INLEXZO |
| What excipients (inactive ingredients) are in INLEXZO? | INLEXZO excipients list |
| DailyMed Link: | INLEXZO at DailyMed |
Pharmacology for INLEXZO
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
US Patents and Regulatory Information for INLEXZO
INLEXZO is protected by six US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683-001 | Sep 9, 2025 | RX | Yes | Yes | 12,636,300 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Janssen Biotech | INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683-001 | Sep 9, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Janssen Biotech | INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683-001 | Sep 9, 2025 | RX | Yes | Yes | 12,403,086 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Janssen Biotech | INLEXZO | gemcitabine hydrochloride | SYSTEM;INTRAVESICAL | 219683-001 | Sep 9, 2025 | RX | Yes | Yes | 8,679,094 | ⤷ 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 |
International Patents for INLEXZO
See the table below for patents covering INLEXZO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014309012 | ⤷ Start Trial | |
| Australia | 2019203394 | ⤷ Start Trial | |
| Australia | 2021282405 | ⤷ Start Trial | |
| Australia | 2024204252 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INLEXZO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0122707 | 96C0030 | Belgium | ⤷ Start Trial | PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327 |
| 0122707 | SPC/GB95/031 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026 |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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