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 | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon Usa Inc | REVERSOL | edrophonium chloride | INJECTABLE;INJECTION | 089624-001 | May 13, 1988 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Organon Usa Inc | HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 000552-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-003 | Oct 13, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Organon | ELOCON | mometasone furoate | LOTION;TOPICAL | 019796-001 | Mar 30, 1989 | DISCN | Yes | No | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Organon Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 129148 | ⤷ Try a Trial |
| Portugal | 1413331 | ⤷ Try a Trial |
| South Africa | 200305694 | ⤷ Try a Trial |
| Slovakia | 9502003 | ⤷ Try a Trial |
| Australia | 2002237927 | ⤷ Try a Trial |
| European Patent Office | 1347987 | ⤷ Try a Trial |
| South Africa | 200705955 | ⤷ 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 |
|---|---|---|---|---|
| 1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
| 2968172 | SPC/GB20/043 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL, AND/OR A SALT OR HYDRATE THEREOF, IN PARTICULAR CALCIFEDIOL MONOHYDRATE; REGISTERED: UK PL 50784/0005-0001 20200721 |
| 2968172 | 122021000009 | Germany | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818 |
| 0720599 | 2003/014 | Ireland | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012 |
| 2481400 | C202130022 | Spain | ⤷ Try a Trial | PRODUCT NAME: CALCIFEDIOL; NATIONAL AUTHORISATION NUMBER: 85519-DE/H/5590/001/DC; DATE OF AUTHORISATION: 20201230; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE/H/5590/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20200721 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 0503785 | CA 2011 00026 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
| >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.
