ORGANON Company Profile
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What is the competitive landscape for ORGANON, and when can generic versions of ORGANON drugs launch?
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.
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 Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-002 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ 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 | DIPROLENE | betamethasone dipropionate | LOTION, AUGMENTED;TOPICAL | 019716-001 | Aug 1, 1988 | 4,775,529 | ⤷ Try a Trial |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-002 | Jul 23, 2004 | RE37721*PED | ⤷ Try a Trial |
Organon | LOTRISONE | betamethasone dipropionate; clotrimazole | CREAM;TOPICAL | 018827-001 | Jul 10, 1984 | 3,705,172 | ⤷ Try a Trial |
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-003 | Oct 13, 1998 | 5,608,075*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 | 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 |
➤ Subscribe | Injection | 250 mcg/0.5 mL, 1 mL PFS | ➤ Subscribe | 2012-03-30 |
International Patents for ORGANON Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Brazil | 0206639 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 02058732 | ⤷ Try a Trial |
Taiwan | I434676 | ⤷ Try a Trial |
Mexico | 2007008880 | ⤷ 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 |
---|---|---|---|---|
0480717 | C990009 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1304992 | C300617 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322 |
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
Here is a list of applicants with similar names.