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.
This drug has one hundred and five patent family members in thirty-four countries.
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
| International Patents: | 105 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 17 |
| Patent Applications: | 790 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEKTURNA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TEKTURNA |
| DailyMed Link: | TEKTURNA at DailyMed |
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 | |||
| 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
Supplementary Protection Certificates for TEKTURNA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C041/2007 | Ireland | ➤ Sign Up | SPC041/2007: 20080416, EXPIRES: 20200406 |
| 0678503/02 | Switzerland | ➤ Sign Up | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
| 315 | Luxembourg | ➤ Sign Up | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
