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-eight 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-seven supplementary protection certificates in fifteen countries.
Summary for ORGANON
| International Patents: | 313 |
| US Patents: | 6 |
| Tradenames: | 52 |
| Ingredients: | 42 |
| NDAs: | 58 |
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 | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon Usa Inc | REVERSOL | edrophonium chloride | INJECTABLE;INJECTION | 089624-001 | May 13, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Organon | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Organon Usa Inc | PAVULON | pancuronium bromide | INJECTABLE;INJECTION | 017015-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ 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 | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | 4,621,077*PED | ⤷ Sign Up |
| Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | 4,444,784*PED | ⤷ Sign Up |
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-002 | May 3, 2013 | 5,969,156*PED | ⤷ Sign Up |
| Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-001 | Jun 29, 1998 | 5,602,162*PED | ⤷ Sign Up |
| Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | 5,994,329 | ⤷ 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 | 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
Supplementary Protection Certificates for ORGANON Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0454511 | SPC/GB99/008 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015 |
| 2435025 | PA2019014 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
| 1110543 | 08C0004 | France | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
| 0733366 | SPC/GB98/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 |
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| >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.
