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Last Updated: August 17, 2022

XEGLYZE Drug Patent Profile


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

Xeglyze is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-five patent family members in fifteen countries.

The generic ingredient in XEGLYZE is abametapir. One supplier is listed for this compound. Additional details are available on the abametapir profile page.

DrugPatentWatch® Generic Entry Outlook for Xeglyze

Xeglyze will be eligible for patent challenges on July 31, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 17, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XEGLYZE
International Patents:35
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 99
Patent Applications: 322
What excipients (inactive ingredients) are in XEGLYZE?XEGLYZE excipients list
DailyMed Link:XEGLYZE at DailyMed
Drug patent expirations by year for XEGLYZE
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XEGLYZE
Generic Entry Date for XEGLYZE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
LOTION;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.

US Patents and Regulatory Information for XEGLYZE

XEGLYZE is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XEGLYZE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XEGLYZE

Pediculicidal composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER

Methods and compositions for controlling ectoparasites
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER

Methods and compositions for controlling ectoparasites
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER

Methods and compositions for controlling ectoparasites
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for controlling ectoparasites
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS 6 MONTHS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting XEGLYZE

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dr Reddys Labs Sa XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Dr Reddys Labs Sa XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dr Reddys Labs Sa XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dr Reddys Labs Sa XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 XEGLYZE

When does loss-of-exclusivity occur for XEGLYZE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14377875
Estimated Expiration: See Plans and Pricing

Canada

Patent: 33081
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1732
Estimated Expiration: See Plans and Pricing

Patent: 1691033
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 82424
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11751
Estimated Expiration: See Plans and Pricing

Patent: 17500342
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0995
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XEGLYZE around the world.

Country Patent Number Title Estimated Expiration
Japan 6711751 See Plans and Pricing
European Patent Office 3082424 COMPOSITION PEDICULICIDE (PEDICULICIDAL COMPOSITION) See Plans and Pricing
China 101132696 Methods and compositions for controlling ectoparasites See Plans and Pricing
European Patent Office 2457582 Procédé et compositions pour le contrôle d'ectoparasites (Method and compositions for controlling ectoparasites) See Plans and Pricing
Canada 2595468 PROCEDES ET COMPOSITIONS SERVANT A LUTTER CONTRE DES ECTOPARASITES (METHODS AND COMPOSITIONS FOR CONTROLLING ECTOPARASITES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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.