DrugPatentWatch Database Preview
TEKTURNA Drug Profile
Which patents cover Tekturna, and when can generic versions of Tekturna launch?
Tekturna is a drug marketed by Noden Pharma and is included in three NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for TEKTURNA
Generic Entry Opportunity Date for TEKTURNA
*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.
Pharmacology for TEKTURNA
| Drug Class | Renin Inhibitor |
| Mechanism of Action | Renin Inhibitors |
Synonyms for TEKTURNA
| (?S,?S,?S,?S)-?-Amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-?-hydroxy-4-methoxy-3-(3-methoxypropoxy)-?,?-bis(1-methylethyl)benzeneoctanamide hemifumarate |
| (2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxo-propyl)-4-hydroxy-2-isopropyl-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-nonanamide; fumaric acid |
| (2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide hemifumarate |
| (2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-2-propan-2-ylnonanamide; (E)-but-2-enedioic acid |
| 1196835-68-3 |
| 173334-58-2 |
| 2C30H53N3O6.C4H4O4 |
| AB0009979 |
| ABP000691 |
| AC1OCFF2 |
| AK174311 |
| AKOS015896419 |
| Aliskiren (hemifumarate) |
| Aliskiren fumarate |
| Aliskiren fumarate (JAN/USAN) |
| Aliskiren fumarate [USAN:JAN] |
| Aliskiren hemifumarate |
| Aliskiren hemifumarate/ |
| AN-6892 |
| AT-45505 |
| Benzeneoctanamide, delta-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-gamma-hydroxy-4-methoxy-3-(3-methoxypropoxy)-alpha,zeta-bis(1-methylethyl)-, (alphaS,gammaS,deltaS,zetaS)-, (2E)-2-butenedioate (2:1) (salt) |
| bis((2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide) fumarate |
| Bis(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methyl-2-(1-methylethyl)nonanamide) (2E)-but-2-enedioate |
| bis{(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methyl-2-(propan-2-yl)nonanamide} (2E)-but-2-enedioate |
| C8A0P8G029 |
| CGP 60536 |
| CGP-60536 |
| CGP-60536B |
| CHEBI:53777 |
| CHEMBL3545059 |
| CS-0729 |
| D06412 |
| EN300-122378 |
| Enviage |
| fumaric acid; bis(tekturna) |
| HY-12177 |
| I06-2020 |
| J10437 |
| KB-47181 |
| KLRSDBSKUSSCGU-KRQUFFFQSA-N |
| KS-1395 |
| MolPort-008-155-823 |
| Riprazo |
| SCHEMBL187762 |
| SPP-100 |
| SPP-100B |
| Sprimeo |
| Tekturna (TN) |
| UNII-C8A0P8G029 |
| W-5448 |
US Patents and Regulatory Information for TEKTURNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Noden Pharma | TEKTURNA | aliskiren hemifumarate | CAPSULE, PELLET;ORAL | 210709-001 | Nov 14, 2017 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | RX | Yes | Yes | ➤ 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 |
Paragraph IV (Patent) Challenges for TEKTURNA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 150 mg and 300 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for TEKTURNA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0678514 | ➤ Sign Up |
| Tunisia | SN06294 | ➤ Sign Up |
| Australia | 1642195 | ➤ Sign Up |
| Hungary | T74074 | ➤ Sign Up |
| Norway | 951441 | ➤ Sign Up |
| Norway | 951443 | ➤ Sign Up |
| South Korea | 101353736 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00528 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
| C0020 | France | ➤ Sign Up | 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 |
| 0296 | Netherlands | ➤ Sign Up | 300296, 20150407, EXPIRES: 20200406 |
| 11/2009 | Austria | ➤ Sign Up | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
| 0678503/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
| 2009 00009 | Denmark | ➤ Sign Up | |
| 00499 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
