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 is included in three NDAs.
The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Singulair
A generic version of SINGULAIR was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3rd, 2012.
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Summary for SINGULAIR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 154 |
| Clinical Trials: | 102 |
| Patent Applications: | 3,980 |
| Drug Prices: | Drug price information for SINGULAIR |
| What excipients (inactive ingredients) are in SINGULAIR? | SINGULAIR excipients list |
| DailyMed Link: | SINGULAIR at DailyMed |
Recent Clinical Trials for SINGULAIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Michael E. DeBakey VA Medical Center | Phase 1 |
| Baylor College of Medicine | Phase 1 |
| Texas A&M University | Phase 1 |
Pharmacology for SINGULAIR
| Drug Class | Leukotriene Receptor Antagonist |
| Mechanism of Action | Leukotriene Receptor Antagonists |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | SINGULAIR | montelukast sodium | TABLET;ORAL | 020829-002 | Feb 20, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-002 | Mar 3, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-001 | Feb 20, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Organon | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-001 | Feb 20, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | SINGULAIR | montelukast sodium | TABLET;ORAL | 020829-002 | Feb 20, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-002 | Mar 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Japan | 4420671 | ⤷ Sign Up | |
| Malaysia | 148466 | GRANULE FORMULATION | ⤷ Sign Up |
| Spain | 2298431 | ⤷ Sign Up | |
| Czech Republic | 281274 | Nenasycené hydroxyalkylchinolinové kyseliny a farmaceutické přípravky na jejich bázi (UNSATURATED HYDROXYALKYL QUINOLINIC ACIDS AND PHARMACEUTICAL PREPARATION BASED THEREON) | ⤷ Sign Up |
| Latvia | 12187 | NEPIESĀTINĀTĀS HIDROKSIALKILĒTAS HINOLĪNA RINDAS KARBONSKĀBES (UNSATURATED HYDROXYALKYLQUINOLINE ACIDS AS LEUKOTRIENE ANTAGONISTS) | ⤷ Sign Up |
| China | 1575163 | ⤷ Sign Up | |
| Norway | 1999002 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 0480717 | 19/1999 | Austria | ⤷ Sign Up | PRODUCT 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 |
| 0480717 | SPC/GB98/025 | United Kingdom | ⤷ Sign Up | PRODUCT 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 |
| 0480717 | 9890027-7 | Sweden | ⤷ Sign Up | PRODUCT 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 |
| 0480717 | C990009 | Netherlands | ⤷ Sign Up | 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 |
| 0480717 | 98C0025 | Belgium | ⤷ Sign Up | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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