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Last Updated: December 7, 2022

Details for Patent: 8,546,428


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Which drugs does patent 8,546,428 protect, and when does it expire?

Patent 8,546,428 protects SIRTURO and is included in one NDA.

This patent has forty patent family members in thirty-three countries.

Summary for Patent: 8,546,428
Title:Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-- beta-phenyl-3-quinolineethanol
Abstract: The present invention relates to the fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-- beta-phenyl-3-quinolineethanol, pharmaceutical compositions comprising as active ingredient said salt and to processes for their preparation.
Inventor(s): Hegyi; Jean Francois Alexandre Lucas (Diest, BE), Aelterman; Wim Albert Alex (Gierle, BE), Lang; Yolande Lydia (Vosselaar, BE), Stokbroekx; Sigrid Carl Maria (Beerse, BE), Leys; Carina (Stabroek, BE), Van Remoortere; Peter Jozef Maria (Kapellen, BE), Faure; Anne (Vosselaar, BE)
Assignee: Janssen Pharmaceutica NV (Beerse, BE)
Application Number:12/515,986
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Process; Formulation; Use;

Drugs Protected by US Patent 8,546,428

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,546,428

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
06125443Dec 5, 2006
PCT Information
PCT FiledDecember 03, 2007PCT Application Number:PCT/EP2007/063186
PCT Publication Date:June 12, 2008PCT Publication Number: WO2008/068231

International Family Members for US Patent 8,546,428

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2498 See Plans and Pricing
Argentina 064149 See Plans and Pricing
Australia 2007328945 See Plans and Pricing
Brazil PI0719693 See Plans and Pricing
Canada 2668512 See Plans and Pricing
Chile 2007003472 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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