TEKAMLO Drug Patent Profile
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Which patents cover Tekamlo, and what generic alternatives are available?
Tekamlo is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-three patent family members in twenty-one countries.
The generic ingredient in TEKAMLO is aliskiren hemifumarate; amlodipine besylate. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate profile page.
DrugPatentWatch® Generic Entry Outlook for Tekamlo
Tekamlo was eligible for patent challenges on March 5, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 21, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TEKAMLO
| International Patents: | 23 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 4 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TEKAMLO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEKAMLO
Generic Entry Date for TEKAMLO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Anatomical Therapeutic Chemical (ATC) Classes for TEKAMLO
US Patents and Regulatory Information for TEKAMLO
TEKAMLO is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKAMLO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting TEKAMLO
Galenical formulations of organic compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 TEKAMLO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEKAMLO
When does loss-of-exclusivity occur for TEKAMLO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3384
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09292908
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0919350
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 36257
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11000594
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2159195
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 51711
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 11010999
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 28564
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 12503020
Estimated Expiration: ⤷ Try a Trial
Patent: 15091830
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 39
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3610
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11002988
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 719
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 110293
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 11115712
Estimated Expiration: ⤷ Try a Trial
Patent: 14140552
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1101644
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 110060942
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1016217
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 11000100
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TEKAMLO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 1642195 | ⤷ Try a Trial | |
| Australia | 699616 | ⤷ Try a Trial | |
| South Korea | 100353779 | ⤷ Try a Trial | |
| Cyprus | 2208 | Delta-amino-gamma-hydroxy-omega-aryl alkanoic acidamides with enzyme especially renin inhibiting ac tivities | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKAMLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1602370 | 09C0020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028 |
| 1602370 | 2009/010 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028 |
| 0678503 | SPC041/2007 | Ireland | ⤷ Try a Trial | SPC041/2007: 20080416, EXPIRES: 20200406 |
| 1507558 | 12C0033 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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