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. Fourteen 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.
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Summary for INSPRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 33 |
| Patent Applications: | 3,605 |
| 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 |
|---|---|
| ACDIMA Biocenter | Phase 1 |
| Darnitsa Pharmaceutical Company | Phase 1 |
| University of Cincinnati | Phase 4 |
Pharmacology for INSPRA
| Drug Class | Aldosterone Antagonist |
| Mechanism of Action | Aldosterone Antagonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-002 | Sep 27, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ 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 INSPRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-001 | Sep 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | INSPRA | eplerenone | TABLET;ORAL | 021437-003 | Sep 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| China | 1230179 | ⤷ Sign Up | |
| Japan | 2002538172 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0051642 | ⤷ Sign Up | |
| European Patent Office | 1126880 | ⤷ Sign Up | |
| Malaysia | 125651 | EPLERENONE COMPOSITIONS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INSPRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0122232 | 91072 | Luxembourg | ⤷ Sign Up | 91072, EXPIRES: 20090410 |
| 0122232 | 2004C/008 | Belgium | ⤷ Sign Up | PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316 |
| 0122232 | 300144 | Netherlands | ⤷ Sign Up | 300144, 20040410, EXPIRES: 20090409 |
| 1135139 | C01135139/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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