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Olmesartan medoxomil - Generic Drug Details
What are the generic sources for olmesartan medoxomil and what is the scope of patent protection?
Olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Qilu, Sandoz Inc, Sciegen Pharms Inc, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-six drug master file entries for olmesartan medoxomil. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for olmesartan medoxomil
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 19 |
| NDAs: | 19 |
| Drug Master File Entries: | 36 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 104 |
| Clinical Trials: | 71 |
| Patent Applications: | 5,433 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for olmesartan medoxomil |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for olmesartan medoxomil |
| DailyMed Link: | olmesartan medoxomil at DailyMed |
Recent Clinical Trials for olmesartan medoxomil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmtechnology LLC | Phase 1 |
| Altasciences Company Inc. | Phase 1 |
| Daiichi Sankyo Co., Ltd. | Phase 3 |
Generic filers with tentative approvals for OLMESARTAN MEDOXOMIL
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 40MG | TABLET;ORAL |
| Start Trial | Start Trial | 20MG | TABLET;ORAL |
| Start Trial | Start Trial | 5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for olmesartan medoxomil
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for olmesartan medoxomil
Paragraph IV (Patent) Challenges for OLMESARTAN MEDOXOMIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BENICAR | TABLET;ORAL | olmesartan medoxomil | 021286 | 2006-04-25 |
US Patents and Regulatory Information for olmesartan medoxomil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 204798-002 | Apr 24, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz Inc | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 090237-001 | Apr 13, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 206631-003 | Apr 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin Ltd | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 206631-001 | Apr 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Micro Labs | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 206372-003 | Sep 17, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent | OLMESARTAN MEDOXOMIL | olmesartan medoxomil | TABLET;ORAL | 202375-003 | Apr 24, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start 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 olmesartan medoxomil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | Start Trial | Start Trial |
| Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | Start Trial | Start Trial |
| Daiichi Sankyo | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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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