MONOPRIL Drug Patent Profile
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When do Monopril patents expire, and what generic alternatives are available?
Monopril is a drug marketed by Bristol Myers Squibb and is included in two NDAs.
The generic ingredient in MONOPRIL is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monopril
A generic version of MONOPRIL was approved as fosinopril sodium; hydrochlorothiazide by SANDOZ on September 28th, 2005.
Summary for MONOPRIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 5 |
| Patent Applications: | 5,306 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | MONOPRIL at DailyMed |
Recent Clinical Trials for MONOPRIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 4 |
| Ranbaxy Laboratories Limited | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for MONOPRIL
US Patents and Regulatory Information for MONOPRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-002 | May 16, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | MONOPRIL-HCT | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 020286-002 | Nov 30, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-003 | May 16, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-004 | Mar 28, 1995 | DISCN | Yes | 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 MONOPRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-004 | Mar 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-004 | Mar 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-002 | May 16, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bristol Myers Squibb | MONOPRIL | fosinopril sodium | TABLET;ORAL | 019915-003 | May 16, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MONOPRIL
See the table below for patents covering MONOPRIL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 0408273 | ⤷ Try a Trial | |
| Austria | 12502 | ⤷ Try a Trial | |
| Spain | 8302728 | ⤷ Try a Trial | |
| Japan | S57126495 | PHOSPHINYLALKANOYL SUBSTITUTED PROLINES | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MONOPRIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0053902 | SPC/GB93/028 | United Kingdom | ⤷ Try a Trial | SPC/GB93/028, EXPIRES: 20050702 |
| 0053902 | SPC/GB96/024 | United Kingdom | ⤷ Try a Trial | SPC/GB96/024:, EXPIRES: 20061126 |
| 0053902 | 96C0036 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FAMCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21325 19960708; FIRST REGISTRATION: GB - 10592/0035 19931210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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