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Last Updated: May 26, 2022

SINGULAIR Drug Patent Profile


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Which patents cover Singulair, and when can generic versions of Singulair launch?

Singulair is a drug marketed by Organon and Msd Merck Co and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Drug patent expirations by year for SINGULAIR
Drug Prices for SINGULAIR

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Drug Sales Revenue Trends for SINGULAIR

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Recent Clinical Trials for SINGULAIR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Whittington Hospital NHS TrustPhase 2/Phase 3
Guy's and St Thomas' NHS Foundation TrustPhase 2/Phase 3
Great Ormond Street Hospital for Children NHS Foundation TrustPhase 2/Phase 3

See all SINGULAIR clinical trials

Paragraph IV (Patent) Challenges for SINGULAIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SINGULAIR Oral Granules montelukast sodium 4 mg 021409 1 2008-10-17
SINGULAIR Tablets montelukast sodium 10 mg 020829 2 2007-02-20
SINGULAIR Chewable Tablets montelukast sodium 4 mg and 5 mg 020830 1 2006-12-26

US Patents and Regulatory Information for SINGULAIR

SINGULAIR is protected by one US patents.

Patents protecting SINGULAIR

Granule formation
Patent Number: See Plans and Pricing
Patent 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
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 AB RX 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

Expired US Patents for SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 See Plans and Pricing See Plans and Pricing
Organon SINGULAIR montelukast sodium GRANULE;ORAL 021409-001 Jul 26, 2002 See Plans and Pricing See Plans and Pricing
Msd Merck Co SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SINGULAIR

See the table below for patents covering SINGULAIR around the world.

Country Patent Number Title Estimated Expiration
Hungary 913217 See Plans and Pricing
Spain 2114882 See Plans and Pricing
Hungary 222344 Eljárás telítetlen hidroxi-alkil-kinolinsavak, és ezeket tartalmazó gyógyszerkészítmények előállítására (PROCESS FOR PRODUCING UNSATURATED HYDROXYALKYLQUINOLINE ACIDS AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SINGULAIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 98C0022 France See Plans and Pricing PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717 98C0025 Belgium See Plans and Pricing PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0480717 C990009 Netherlands See Plans and Pricing PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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