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Telmisartan - Generic Drug Details
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This ingredient has seventy-seven patent family members in thirty-seven countries.
There are thirty-six drug master file entries for telmisartan. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for Generic Name: telmisartan
| Tradenames: | 2 |
| Patents: | 3 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 36 |
| Suppliers / Packaging: see list | 18 |
| Therapeutic Class: | Cardiovascular Agents |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: telmisartan
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Tentative approvals for TELMISARTAN
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 40MG; 12.5MG |
| <disabled> | <disabled> | TABLET; ORAL | 80MG; 12.5MG |
| <disabled> | <disabled> | TABLET; ORAL | 80MG; 25MG |
Clinical Trials for: telmisartan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | RX | Yes | 6,358,986 | Jan 10, 2020 | ||||||||||||||||||||
Amneal Pharms | TELMISARTAN | telmisartan | TABLET;ORAL | 204415-002 | Sep 8, 2015 | RX | No | ||||||||||||||||||||||
Zydus Pharms Usa Inc | TELMISARTAN | telmisartan | TABLET;ORAL | 203325-003 | Aug 26, 2014 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: telmisartan
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | 5,591,762 | <disabled> | ||||||||||||||||||||||
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | 5,591,762 | <disabled> | ||||||||||||||||||||||
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | 5,591,762 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: telmisartan
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,604,070 | Use of inhibitors of the renin-angiotensin system | <disabled in preview> | |||||||||||||||||||||||||||
| 6,410,742 | Polymorphs of telmisartan | <disabled in preview> | |||||||||||||||||||||||||||
| 7,071,183 | Use of inhibitors of the renin-angiotensin system | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Ingredient: telmisartan
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Croatia | P20010514 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 1336920 | <disabled in preview> | |||||||||||||||||||||||||||
| Spain | 2238770 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: TELMISARTAN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /1999 | Austria | <disabled> | PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/98/089/001-010 19981211; FIRST REGISTRATION: BE K (1998) 4288-DE 19981211 | ||||||||||||||||||||||||||
| 0502314/03 | Switzerland | <disabled> | PRODUCT NAME: TELMISARTAN + AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 61270 08.11.2010 | ||||||||||||||||||||||||||
| C/GB99/014 | United Kingdom | <disabled> | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211 | ||||||||||||||||||||||||||
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