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Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide - Generic Drug Details
What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide freedom to operate?
Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has one hundred and eighty-three patent family members in thirty-five countries.
There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide.
Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| International Patents: | 183 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Clinical Trials: | 768 |
| Drug Prices: | see low prices |
| DailyMed Link: | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed |
US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | 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 |
Non-Orange Book US Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
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 |
|---|---|---|
| 5,646,143 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ➤ Sign Up |
| 5,654,445 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids | ➤ Sign Up |
| 5,659,065 | Alpha-aminoalkanoic acids and reduction products | ➤ Sign Up |
| 5,606,078 | 3,5-Disubstituted tetrahydrofuran-2-ones | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Australia | 2368002 | ➤ Sign Up |
| South Korea | 20100114904 | ➤ Sign Up |
| China | 1117960 | ➤ Sign Up |
| Denmark | 1341533 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0063 | France | ➤ Sign Up | PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414 |
| 2012 00018 | Denmark | ➤ Sign Up | PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705 |
| 2012 00018 | Denmark | ➤ Sign Up | |
| 0678503/02 | Switzerland | ➤ Sign Up | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
