INSPRA Drug Patent Profile
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When do Inspra patents expire, and when can generic versions of Inspra launch?
Inspra is a drug marketed by Upjohn and is included in one NDA.
The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Inspra
A generic version of INSPRA was approved as eplerenone by CHARTWELL RX on July 30th, 2008.
Summary for INSPRA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 33 |
Patent Applications: | 3,497 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INSPRA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INSPRA |
What excipients (inactive ingredients) are in INSPRA? | INSPRA excipients list |
DailyMed Link: | INSPRA at DailyMed |
Recent Clinical Trials for INSPRA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Darnitsa Pharmaceutical Company | Phase 1 |
ACDIMA Biocenter | Phase 1 |
University of Cincinnati | Phase 4 |
Pharmacology for INSPRA
Drug Class | Aldosterone Antagonist |
Mechanism of Action | Aldosterone Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for INSPRA
Paragraph IV (Patent) Challenges for INSPRA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INSPRA | Injection | eplerenone | 0.75 mg/mL, 100 mL vial | 021437 | 1 | 2009-06-05 |
INSPRA | Tablets | eplerenone | 25 mg and 50 mg | 021437 | 2 | 2006-09-27 |
US Patents and Regulatory Information for INSPRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-001 | Sep 27, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-002 | Sep 27, 2002 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | DISCN | No | No | ⤷ Try a Trial | ⤷ 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 INSPRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-002 | Sep 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-002 | Sep 27, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INSPRA
See the table below for patents covering INSPRA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 9915134 | ⤷ Try a Trial | |
Finland | 841400 | ⤷ Try a Trial | |
Turkey | 200101643 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INSPRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0122232 | 2004C/008 | Belgium | ⤷ Try a Trial | PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316 |
0122232 | 91072 | Luxembourg | ⤷ Try a Trial | 91072, EXPIRES: 20090410 |
1135139 | C01135139/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |