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.
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 | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon | COZAAR | losartan potassium | TABLET;ORAL | 020386-001 | Apr 14, 1995 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon Llc | XACIATO | clindamycin phosphate | GEL;VAGINAL | 215650-001 | Dec 7, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
>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 | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865-002 | Jun 29, 1998 | 5,457,895*PED | ⤷ Sign Up |
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-001 | May 30, 1991 | 4,900,755 | ⤷ Sign Up |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | 6,057,307*PED | ⤷ Sign Up |
>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 | 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 |
➤ Subscribe | Oral Solution | 70 mg/75 mL | ➤ Subscribe | 2007-09-07 |
International Patents for Organon Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Mexico | 2007008880 | ⤷ Sign Up |
Japan | 4777602 | ⤷ Sign Up |
Argentina | 056923 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Organon Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0247633 | C970034 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107 |
0502314 | SPC/GB02/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
0480717 | 98C0022 | France | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.