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Generated: June 28, 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 are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 2 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 35 |
| Suppliers / Packagers: see list | 22 |
| 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa Inc | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 205192-002 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Teva Pharms Usa | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 091079-002 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Glenmark Pharms Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 203281-001 | May 25, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Aurobindo Pharma Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 204798-003 | Apr 24, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Pharms Inc | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 078276-001 | Oct 26, 2016 | AB | RX | No | No | ► 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 | 5,616,599*PED | ► Subscribe | ||||||||||||||||||||||
Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | 5,616,599*PED | ► Subscribe | ||||||||||||||||||||||
Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | 5,616,599*PED | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Israel | 114996 | ► Subscribe | |||||||||||||||||||||||||||
| Finland | 932492 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1085896 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 931980 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 223667 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011 | Austria | ► Subscribe | PRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216 | ||||||||||||||||||||||||||
| 0503785/02 | Switzerland | ► Subscribe | FORMER OWNER: SANKYO COMPANY LIMITED, JP | ||||||||||||||||||||||||||
| 00375 | Netherlands | ► Subscribe | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 | ||||||||||||||||||||||||||
| 0133 | Netherlands | ► Subscribe | 300133, 20120221, EXPIRES: 20170220 | ||||||||||||||||||||||||||
| 056 | Luxembourg | ► Subscribe | 91056, EXPIRES: 20170221 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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