Organon Llc Company Profile
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What is the competitive landscape for ORGANON LLC, and when can generic versions of ORGANON LLC drugs launch?
ORGANON LLC has nine approved drugs.
There is one US patent protecting ORGANON LLC drugs.
There are eight patent family members on ORGANON LLC drugs in ten countries and fifty-five supplementary protection certificates in fifteen countries.
Drugs and US Patents for Organon Llc
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon Llc | XACIATO | clindamycin phosphate | GEL;VAGINAL | 215650-001 | Dec 7, 2021 | RX | Yes | Yes | 11,129,896 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Llc | SINEMET CR | carbidopa; levodopa | TABLET, EXTENDED RELEASE;ORAL | 019856-002 | Dec 24, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | RX | 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 Llc
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | 5,889,015*PED | ⤷ Try a Trial |
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-002 | Apr 26, 2007 | 5,358,941*PED | ⤷ Try a Trial |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | 5,829,434*PED | ⤷ Try a Trial |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | 6,057,307*PED | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for ORGANON LLC drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Nasal Spray | 50 mcg/ Spray | ➤ Subscribe | 2009-08-07 |
➤ Subscribe | Tablets | 5 mg and 10 mg | ➤ Subscribe | 2004-09-02 |
➤ Subscribe | Tablets | 70 mg/2800 IU and 70 mg/5600 IU | ➤ Subscribe | 2007-11-20 |
International Patents for Organon Llc Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Portugal | 3324938 | ⤷ Try a Trial |
Lithuania | 3324938 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2017015232 | ⤷ Try a Trial |
Mexico | 2022001736 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Organon Llc Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 92401 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
2435025 | CR 2019 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220 |
2435024 | C202130025 | Spain | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209 |
2435024 | LUC00208 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.