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Generated: August 20, 2017
What are the generic sources for olmesartan medoxomil and what is the scope of olmesartan medoxomil freedom to operate?
Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Macleods Pharms Ltd, Lupin Ltd, Accord Hlthcare, Alkem Labs Ltd, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Glenmark Pharms Ltd, Jubilant Generics, Daiichi Sankyo, Zydus Pharms Usa Inc, and Aurobindo Pharma Ltd, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 35 |
| Suppliers / Packagers: see list | 23 |
| Bulk Api Vendors: see list | 81 |
| Clinical Trials: see list | 125 |
| Patent Applications: see list | 4,265 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | olmesartan medoxomil at DailyMed |
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 5MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 40MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 20MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jubilant Generics | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 205482-001 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Accord Hlthcare | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 207662-001 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Torrent Pharms Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 202375-003 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Alkem Labs Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 206763-001 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Lupin Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 206631-002 | Apr 27, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,646,171 | Angiotensin II antagonist 1-biphenylmethylimidazole compounds and their therapeutic use | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 647887 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 300375 | ► Subscribe | |||||||||||||||||||||||||||
| Greece | 3035909 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 9601179 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 122011000011 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2009 00015 | Denmark | ► Subscribe | PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819 | ||||||||||||||||||||||||||
| /2009 | Austria | ► Subscribe | PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819 | ||||||||||||||||||||||||||
| 847 | Luxembourg | ► Subscribe | 91847, EXPIRES: 20170221 | ||||||||||||||||||||||||||
| 0503785/02 | Switzerland | ► Subscribe | FORMER OWNER: SANKYO COMPANY LIMITED, JP | ||||||||||||||||||||||||||
| 00486 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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