Organon Company Profile
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What is the competitive landscape for ORGANON, and what generic alternatives to ORGANON drugs are available?
ORGANON has forty-three approved drugs.
There are eight US patents protecting ORGANON drugs. There is one tentative approval on ORGANON drugs.
There are three hundred and seventy-one patent family members on ORGANON drugs in forty-six countries and one hundred and twenty-three supplementary protection certificates in sixteen countries.
Drugs and US Patents for Organon
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon Usa Inc | PAVULON | pancuronium bromide | INJECTABLE;INJECTION | 017015-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | |||||
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | ||||
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-001 | Apr 14, 1995 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | ||||
Organon Usa Inc | LYNORAL | ethinyl estradiol | TABLET;ORAL | 005490-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-001 | Dec 23, 1991 | AB | RX | Yes | No | 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 Organon
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | 4,444,784 | See Plans and Pricing |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | 4,444,784*PED | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | 7,265,099 | See Plans and Pricing |
Organon Sub Merck | BRIDION | sugammadex sodium | SOLUTION;INTRAVENOUS | 022225-001 | Dec 15, 2015 | 7,265,009 | See Plans and Pricing |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | 5,846,966*PED | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ORGANON drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | 2006-10-25 |
➤ Subscribe | Injection | 250 mcg/0.5 mL, 1 mL PFS | ➤ Subscribe | 2012-03-30 |
➤ Subscribe | Tablets | 10 mg | ➤ Subscribe | 2007-02-20 |
➤ Subscribe | Nasal Spray | 50 mcg/ Spray | ➤ Subscribe | 2009-08-07 |
➤ Subscribe | Orally Disintegrating Tablets | 2.5 mg and 5 mg | ➤ Subscribe | 2006-06-21 |
➤ Subscribe | Tablets | 50 mg/12.5 mg and 100 mg/25 mg | ➤ Subscribe | 2004-05-24 |
➤ Subscribe | Tablets | 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg | ➤ Subscribe | 2009-07-27 |
➤ Subscribe | Vaginal Ring | 0.015 mg/24 hour and 0.12 mg/24 hour | ➤ Subscribe | 2013-06-17 |
➤ Subscribe | Chewable Tablets | 4 mg and 5 mg | ➤ Subscribe | 2006-12-26 |
➤ Subscribe | Tablets | 5 mg | ➤ Subscribe | 2006-06-21 |
➤ Subscribe | Tablets | 70 mg/2800 IU and 70 mg/5600 IU | ➤ Subscribe | 2007-11-20 |
➤ Subscribe | Tablets | 100 mg/12.5 mL | ➤ Subscribe | 2006-04-04 |
International Patents for Organon Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Czech Republic | 20032030 | See Plans and Pricing |
Israel | 184586 | See Plans and Pricing |
European Patent Office | 3417905 | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 02058733 | See Plans and Pricing |
Slovakia | 286282 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Organon Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 300689 | Netherlands | See Plans and Pricing | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912 |
1003503 | 05C0048 | France | See Plans and Pricing | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
0398460 | C300221 | Netherlands | See Plans and Pricing | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
2435025 | 36/2019 | Austria | See Plans and Pricing | PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220 |
0720599 | C300172 | Netherlands | See Plans and Pricing | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.