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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Covington
Fuji
Merck
Colorcon
UBS
Teva
Baxter
QuintilesIMS
Accenture

Generated: October 24, 2017

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SINGULAIR Drug Profile

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What is the patent landscape for Singulair, and what generic Singulair alternatives are available?

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

This drug has twenty-eight patent family members in twenty-five countries and five supplementary protection certificates in five countries.

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

Summary for Tradename: SINGULAIR

US Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list7
Bulk Api Vendors: see list66
Clinical Trials: see list87
Patent Applications: see list2,018
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SINGULAIR at DailyMed

Pharmacology for Tradename: SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET;ORAL020829-002Feb 20, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: SINGULAIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
SINGULAIR
montelukast sodium
GRANULE;ORAL021409-001Jul 26, 2002► Subscribe► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-002Mar 3, 2000► Subscribe► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET;ORAL020829-002Feb 20, 1998► Subscribe► Subscribe
Merck
SINGULAIR
montelukast sodium
TABLET, CHEWABLE;ORAL020830-001Feb 20, 1998► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for SINGULAIR

Drugname Dosage Strength RLD Submissiondate
montelukastTablets10 mgSingulair2/20/2007
montelukast sodiumChewable Tablets4 mg and 5 mgSingulair12/26/2006

International Patent Family for Tradename: SINGULAIR

Country Document Number Estimated Expiration
Israel161299► Subscribe
Germany60225040► Subscribe
Hungary0401670► Subscribe
China1575163► Subscribe
Denmark1441701► Subscribe
Norway20042167► Subscribe
CroatiaP20040367► Subscribe
Austria385781► Subscribe
South Korea101094084► Subscribe
Japan2005510497► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SINGULAIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90009Netherlands► SubscribePRODUCT 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
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
90027-7Sweden► SubscribePRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
/1999Austria► SubscribePRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
Argus Health
Chubb
Dow
Express Scripts
AstraZeneca
Baxter
Healthtrust
Teva

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 verifification 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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