BENICAR Drug Patent Profile
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When do Benicar patents expire, and what generic alternatives are available?
Benicar is a drug marketed by Cosette and is included in two NDAs.
The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Benicar
A generic version of BENICAR was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11th, 2024.
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Questions you can ask:
- What is the 5 year forecast for BENICAR?
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- What is Average Wholesale Price for BENICAR?
Summary for BENICAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 17 |
| Patent Applications: | 4,600 |
| Drug Prices: | Drug price information for BENICAR |
| Drug Sales Revenues: | Drug sales revenues for BENICAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENICAR |
| What excipients (inactive ingredients) are in BENICAR? | BENICAR excipients list |
| DailyMed Link: | BENICAR at DailyMed |
Recent Clinical Trials for BENICAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 3 |
| Daiichi Sankyo Co., Ltd. | N/A |
| Chinese PLA General Hospital | Phase 4 |
Pharmacology for BENICAR
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Paragraph IV (Patent) Challenges for BENICAR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BENICAR | Tablets | olmesartan medoxomil | 5 mg, 20 mg and 40 mg | 021286 | 1 | 2006-04-25 |
US Patents and Regulatory Information for BENICAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | 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 BENICAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BENICAR
See the table below for patents covering BENICAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 241681 | IMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Greece | 3035624 | ⤷ Sign Up | |
| Finland | 955248 | ⤷ Sign Up | |
| Norway | 954507 | ⤷ Sign Up | |
| European Patent Office | 1336407 | COMPOSITION COMPRENANT UN ANTAGONIST DU RECEPTEUR DE L'ANGIOTENSINE II ET UN DIURETIQUE ET LEUR UTILISATION POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITION CONTAINING AN ANGIOTENSIN II RECEPTOR ANTAGONIST AND A DIURETIC AND ITS USE FOR THE TREATMENT OF HYPERTENSION) | ⤷ Sign Up |
| Russian Federation | 2128173 | DERIVATIVES OF 1-BIPHENYLMETHYLIMIDAZOLE, A METHOD OF THEIR SYNTHESIS AND A PHARMACEUTICAL COMPOSITION FOR TREATMENT AND PROPHYLAXIS OF PATIENTS WITH HYPERTENSION | ⤷ Sign Up |
| Russian Federation | 2261708 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BENICAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0503785 | C00503785/04 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0503785 | SPC/GB03/024 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522 |
| 0503785 | C00503785/02 | Switzerland | ⤷ Sign Up | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
| 0503785 | 91571 | Luxembourg | ⤷ Sign Up | 91571, EXPIRES: 20170221 |
| 0503785 | C00503785/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
| 0503785 | 91056 | Luxembourg | ⤷ Sign Up | 91056, EXPIRES: 20170221 |
| 0503785 | 9/2011 | Austria | ⤷ Sign Up | 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 |
| >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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