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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 09292908
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0919350
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 36257
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11000594
Estimated Expiration: ⤷ Sign Up
China
Patent: 2159195
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 51711
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 11010999
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 28564
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 12503020
Estimated Expiration: ⤷ Sign Up
Patent: 15091830
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 39
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 3610
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11002988
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 719
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 110293
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 11115712
Estimated Expiration: ⤷ Sign Up
Patent: 14140552
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1101644
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 110060942
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 1016217
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 11000100
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Finland | 951771 | ⤷ Sign Up | |
| Hungary | 226860 | NEW DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYL-ALKANE-CARBOXYLIC-ACID-AMIDES, PROCESS FOR PREPARING THEM AND PHARMACEUTICAL COMPNS. CONTG. THEM | ⤷ Sign Up |
| Hungary | T74074 | ⤷ Sign Up | |
| China | 1117960 | ⤷ Sign Up | |
| China | 1153759 | ⤷ Sign Up | |
| Germany | 122009000020 | ⤷ Sign Up | |
| Czech Republic | 9500976 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEKAMLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1507558 | 1290018-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
| 1915993 | 300625 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
| 1602370 | 132009901728448 | Italy | ⤷ Sign Up | PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116 |
| 1915993 | 1390055-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414 |
| 0678503 | CA 2007 00049 | Denmark | ⤷ Sign Up | |
| 0678503 | 07C0055 | France | ⤷ Sign Up | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 2305232 | 132019000000150 | Italy | ⤷ Sign Up | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120 |
| >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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