Singulair Drug Patent Profile
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When do Singulair patents expire, and what generic alternatives are available?
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.
Summary for Singulair
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 154 |
Clinical Trials: | 101 |
Patent Applications: | 4,166 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Assaf-Harofeh Medical Center | Phase 4 |
The Whittington Hospital NHS Trust | Phase 2/Phase 3 |
Guy's and St Thomas' NHS Foundation Trust | Phase 2/Phase 3 |
Pharmacology for Singulair
Drug Class | Leukotriene Receptor Antagonist |
Mechanism of Action | Leukotriene Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for Singulair
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | SINGULAIR | montelukast sodium | TABLET;ORAL | 020829-002 | Feb 20, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-002 | Mar 3, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-001 | Feb 20, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | TABLET, CHEWABLE;ORAL | 020830-002 | Mar 3, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-001 | Feb 20, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | SINGULAIR | montelukast sodium | TABLET;ORAL | 020829-002 | Feb 20, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Norway | 180716 | ⤷ Try a Trial | |
Hong Kong | 1027473 | ⤷ Try a Trial | |
Spain | 2114882 | ⤷ Try a Trial | |
Malaysia | 148466 | GRANULE FORMULATION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Singulair
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0480717 | 98C0025 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
0480717 | 98C0022 | France | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |