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Last Updated: September 30, 2022

FENSOLVI KIT Drug Patent Profile


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When do Fensolvi Kit patents expire, and when can generic versions of Fensolvi Kit launch?

Fensolvi Kit is a drug marketed by Tolmar and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-eight patent family members in twenty-six countries.

The generic ingredient in FENSOLVI KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for FENSOLVI KIT
International Patents:68
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Formulation / Manufacturing:see details
DailyMed Link:FENSOLVI KIT at DailyMed
Drug patent expirations by year for FENSOLVI KIT

US Patents and Regulatory Information for FENSOLVI KIT

FENSOLVI KIT is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting FENSOLVI KIT

Sustained release polymer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY

FDA Regulatory Exclusivity protecting FENSOLVI KIT

TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY (CPP)
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
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 RX Yes Yes 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

Expired US Patents for FENSOLVI KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 See Plans and Pricing See Plans and Pricing
Tolmar FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FENSOLVI KIT

See the table below for patents covering FENSOLVI KIT around the world.

Country Patent Number Title Estimated Expiration
Germany 60111068 See Plans and Pricing
Poland 361671 See Plans and Pricing
Brazil 0114069 See Plans and Pricing
South Africa 200302944 Polymeric delivery formulations of leuprolide with improved efficacy. See Plans and Pricing
Slovenia 1322286 See Plans and Pricing
Australia 2010201645 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Mallinckrodt

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.