CIPRODEX Drug Patent Profile
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Which patents cover Ciprodex, and when can generic versions of Ciprodex launch?
Ciprodex is a drug marketed by Sandoz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has nineteen patent family members in sixteen countries.
The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprodex
A generic version of CIPRODEX was approved as ciprofloxacin; dexamethasone by DR REDDYS on August 10th, 2020.
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Questions you can ask:
- What is the 5 year forecast for CIPRODEX?
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Summary for CIPRODEX
International Patents: | 19 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 10 |
Patent Applications: | 60 |
Drug Prices: | Drug price information for CIPRODEX |
Drug Sales Revenues: | Drug sales revenues for CIPRODEX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CIPRODEX |
What excipients (inactive ingredients) are in CIPRODEX? | CIPRODEX excipients list |
DailyMed Link: | CIPRODEX at DailyMed |
Paragraph IV (Patent) Challenges for CIPRODEX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CIPRODEX | Otic Suspension | ciprofloxacin; dexamethasone | 0.3%/0.1% | 021537 | 1 | 2012-07-31 |
US Patents and Regulatory Information for CIPRODEX
CIPRODEX is protected by one US patents.
Patents protecting CIPRODEX
Method of treating middle ear infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE OTITIS MEDIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 CIPRODEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CIPRODEX
See the table below for patents covering CIPRODEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1376054 | ⤷ Sign Up | |
Spain | 2250739 | ⤷ Sign Up | |
European Patent Office | 1429780 | PROCEDE DE TRAITEMENT DE L'INFECTION DE L'OREILLE MOYENNE (METHOD OF TREATING MIDDLE EAR INFECTIONS) | ⤷ Sign Up |
Japan | S63203629 | LOCALLY APPLICABLE BLEND OF DILASE INHIBITOR COMBINED WITH CORTICOSTEROIDS | ⤷ Sign Up |
China | 1158994 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CIPRODEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1429780 | 122012000070 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808 |
1429780 | CA 2012 00045 | Denmark | ⤷ Sign Up | |
1429780 | SPC/GB12/058 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
1429780 | 13C0012 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
1429780 | 132013902137451 | Italy | ⤷ Sign Up | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |