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Harvard Business School
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Last Updated: June 3, 2023

Organon Company Profile


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Summary for Organon
International Patents:425
US Patents:10
Tradenames:56
Ingredients:43
NDAs:59

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 FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Organon PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Organon Usa Inc LYNORAL ethinyl estradiol TABLET;ORAL 005490-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Organon CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Organon DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988 DISCN Yes No ⤷  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 Organon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon LIPTRUZET atorvastatin calcium; ezetimibe TABLET;ORAL 200153-003 May 3, 2013 5,686,104*PED ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 5,687,710*PED ⤷  Try a Trial
Organon LIPTRUZET atorvastatin calcium; ezetimibe TABLET;ORAL 200153-001 May 3, 2013 RE42461*PED ⤷  Try a Trial
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995 5,210,079*PED ⤷  Try a Trial
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 RE29892 ⤷  Try a Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 RE42461*PED ⤷  Try a Trial
>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 Oral Solution 70 mg/75 mL ➤ Subscribe 2007-09-07
➤ Subscribe Tablets 100 mg/12.5 mL ➤ Subscribe 2006-04-04
➤ Subscribe Tablets 10 mg ➤ Subscribe 2006-10-25
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 2007-11-20
➤ Subscribe Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30
➤ Subscribe Tablets 10 mg ➤ Subscribe 2007-02-20
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Orally Disintegrating Tablets 5 mg and 10 mg ➤ Subscribe 2006-02-17
➤ 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 Nasal Spray 50 mcg/ Spray ➤ Subscribe 2009-08-07
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-09-02
➤ Subscribe Vaginal Ring 0.015 mg/24 hour and 0.12 mg/24 hour ➤ Subscribe 2013-06-17
➤ Subscribe Topical Solution (Lotion) 0.10% ➤ Subscribe 2004-06-10
➤ Subscribe Chewable Tablets 4 mg and 5 mg ➤ Subscribe 2006-12-26
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21

Supplementary Protection Certificates for Organon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0152897 2001C/013 Belgium ⤷  Try a Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1003503 05C0048 France ⤷  Try a Trial 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
0720599 05C0040 France ⤷  Try a Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
2481400 C02481400/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020
0277829 C300016 Netherlands ⤷  Try a Trial PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
0277829 27/2000 Austria ⤷  Try a Trial PRODUCT NAME: GANIRELIX ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
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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