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Baxter
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Last Updated: June 28, 2022

Organon Company Profile


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Summary for Organon
International Patents:371
US Patents:8
Tradenames:46
Ingredients:38
NDAs:43

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

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
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Moodys
Harvard Business School
McKesson
Medtronic

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