AMARYL Drug Patent Profile
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Which patents cover Amaryl, and what generic alternatives are available?
Amaryl is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in AMARYL is glimepiride. There are sixteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amaryl
A generic version of AMARYL was approved as glimepiride by CHARTWELL MOLECULAR on October 6th, 2005.
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Questions you can ask:
- What is the 5 year forecast for AMARYL?
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- What is Average Wholesale Price for AMARYL?
Summary for AMARYL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 154 |
| Clinical Trials: | 69 |
| Patent Applications: | 4,164 |
| Drug Prices: | Drug price information for AMARYL |
| What excipients (inactive ingredients) are in AMARYL? | AMARYL excipients list |
| DailyMed Link: | AMARYL at DailyMed |
Recent Clinical Trials for AMARYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Damanhour University | N/A |
| PT Pharma Metric Labs | N/A |
| PT Harsen Laboratories | N/A |
US Patents and Regulatory Information for AMARYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-001 | Nov 30, 1995 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-003 | Nov 30, 1995 | AB | RX | Yes | 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 AMARYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-001 | Nov 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-003 | Nov 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMARYL
See the table below for patents covering AMARYL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3067390 | ⤷ Sign Up | |
| Mexico | 8352 | PROCEDIMIENTO PARA LA ELABORACION DE SULFONILUREAS Y PRODUCTO RESULTANTE. | ⤷ Sign Up |
| Mexico | 8254 | PROCEDIMIENTO PARA LA ELABORACION DE SULFONIL UREAS Y PRODUCTO RESULTANTE | ⤷ Sign Up |
| Germany | 2951135 | ⤷ Sign Up | |
| Norway | 803855 | ⤷ Sign Up | |
| Netherlands | 950026 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMARYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0031058 | SPC/GB97/012 | United Kingdom | ⤷ Sign Up | |
| 0031058 | 98C0008 | Belgium | ⤷ Sign Up | PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203 |
| 1174135 | SPC/GB10/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU |
| >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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