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 fifty-nine approved drugs.
There are six US patents protecting ORGANON drugs. There is one tentative approval on ORGANON drugs.
There are three hundred and thirteen patent family members on ORGANON drugs in forty-four countries and one hundred and thirty-six supplementary protection certificates in fifteen countries.
Summary for Organon
| International Patents: | 313 |
| US Patents: | 6 |
| 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 | DIPROLENE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 019716-001 | Aug 1, 1988 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-003 | Oct 20, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-003 | Aug 12, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Organon | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon | NEXPLANON | etonogestrel | IMPLANT;IMPLANTATION | 021529-002 | May 13, 2011 | RX | Yes | Yes | 9,757,552 | ⤷ Try a Trial | Y | ⤷ 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 Llc | CLARINEX-D 12 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021313-001 | Feb 1, 2006 | 7,214,684*PED | ⤷ Try a Trial |
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | 5,849,726*PED | ⤷ Try a Trial |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | 5,608,075 | ⤷ Try a Trial |
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-001 | Jun 29, 1998 | 5,602,162*PED | ⤷ Try a Trial |
| Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-001 | Apr 14, 1995 | 5,210,079*PED | ⤷ Try a Trial |
| Organon | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-001 | Jun 29, 1998 | 4,305,502 | ⤷ Try a Trial |
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | 5,804,570 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Organon Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20040025889 | ⤷ Try a Trial |
| Russian Federation | 2003126184 | ⤷ Try a Trial |
| Portugal | 1427409 | ⤷ Try a Trial |
| South Africa | 200305693 | ⤷ Try a Trial |
| Japan | 5168695 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2017015232 | ⤷ Try a Trial |
| Austria | E399569 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Organon Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 0720599 | C300688 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724 |
| 0497512 | 99C0011 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211 |
| 0497512 | SPC/GB98/035 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624 |
| 0443983 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
| 0247633 | 97C0103 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107 |
| >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.
Here is a list of applicants with similar names.
