WIDAPLIK Drug Patent Profile
Which patents cover Widaplik, and what generic alternatives are available?
Widaplik is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug.
The generic ingredient in WIDAPLIK is amlodipine besylate; indapamide; telmisartan. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; indapamide; telmisartan profile page.
DrugPatentWatch® Generic Entry Outlook for Widaplik
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 23, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
US Patents and Regulatory Information for WIDAPLIK
WIDAPLIK is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of WIDAPLIK is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423-001 | Jun 5, 2025 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Azurity | WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423-003 | Jun 5, 2025 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Azurity | WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423-002 | Jun 5, 2025 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Azurity | WIDAPLIK | amlodipine besylate; indapamide; telmisartan | TABLET;ORAL | 219423-003 | Jun 5, 2025 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for WIDAPLIK
When does loss-of-exclusivity occur for WIDAPLIK?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 18213147
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 19309329
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 23274064
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 25201831
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 25287416
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 26204461
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 26238014
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2019015368
Patent: composições para o tratamento de hipertensão
Estimated Expiration: ⤷ Start Trial
Patent: 2021001374
Patent: composições para o tratamento da hipertensão
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 51374
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 07616
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
China
Patent: 0545819
Patent: 用于治疗高血压的组合物 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 2770746
Patent: 用于治疗高血压的组合物 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 6327958
Patent: 用于治疗高血压的组合物 (Composition for treating hypertension)
Estimated Expiration: ⤷ Start Trial
Patent: 9386015
Patent: 用于治疗高血压的组合物 (Composition for treating hypertension)
Estimated Expiration: ⤷ Start Trial
Patent: 0585831
Patent: 用于治疗高血压的组合物 (Composition for treating hypertension)
Estimated Expiration: ⤷ Start Trial
Patent: 2272578
Patent: 用于治疗高血压的组合物
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0230267
Estimated Expiration: ⤷ Start Trial
Patent: 0240701
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 73620
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 26633
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Patent: COMPOSITIONS POUR L'UTILISATION DANS LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR USE IN THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 74915
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 09913
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 20524
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 35566
Patent: COMPOSITIONS POUR LE TRAITEMENT DE L'HYPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Finland
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 61444
Estimated Expiration: ⤷ Start Trial
Patent: 67617
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 74738
Estimated Expiration: ⤷ Start Trial
Patent: 05274
Estimated Expiration: ⤷ Start Trial
Patent: 20506180
Patent: 高血圧症の処置のための組成物
Estimated Expiration: ⤷ Start Trial
Patent: 22511588
Patent: 高血圧症の処置のための組成物
Estimated Expiration: ⤷ Start Trial
Patent: 23063282
Patent: 高血圧症の処置のための組成物
Estimated Expiration: ⤷ Start Trial
Patent: 24099574
Patent: 高血圧症の処置のための組成物 (COMPOSITION FOR TREATING HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 25010535
Patent: 高血圧症の処置のための組成物 (COMPOSITIONS FOR TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 26031933
Patent: 高血圧症の処置のための組成物 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 26104977
Patent: 高血圧症の処置のための組成物
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 19008813
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE LA HIPERTENSION. (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION.)
Estimated Expiration: ⤷ Start Trial
Patent: 21001043
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE HIPERTENSION. (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION.)
Estimated Expiration: ⤷ Start Trial
Patent: 23004366
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE LA HIPERTENSION. (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION.)
Estimated Expiration: ⤷ Start Trial
Patent: 25000236
Patent: COMPOSICIONES PARA EL TRATAMIENTO DE HIPERTENSION (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 19126749
Patent: КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ГИПЕРТЕНЗИИ
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 042
Patent: KOMPOZICIJE ZA LEČENJE HIPERTENZIJE (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 701
Patent: KOMPOZICIJE ZA UPOTREBU U LEČENJU HIPERTENZIJE (COMPOSITIONS FOR USE IN THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 73620
Estimated Expiration: ⤷ Start Trial
Patent: 01454
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 2006591
Patent: COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 190127691
Patent: 고혈압의 치료를 위한 조성물
Estimated Expiration: ⤷ Start Trial
Patent: 210038931
Patent: 고혈압 치료용 조성물
Estimated Expiration: ⤷ Start Trial
Patent: 240096848
Patent: 고혈압의 치료를 위한 조성물 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 250052479
Patent: 고혈압의 치료를 위한 조성물 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 250107955
Patent: 고혈압의 치료를 위한 조성물 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 260049874
Patent: 고혈압 치료용 조성물 (COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION)
Estimated Expiration: ⤷ Start Trial
Patent: 260150777
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 40316
Estimated Expiration: ⤷ Start Trial
Patent: 81657
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 1831204
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 2023619
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 2319049
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 2421198
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 2508572
Patent: Compositions for the treatment of hypertension
Estimated Expiration: ⤷ Start Trial
Patent: 25279
Estimated Expiration: ⤷ Start Trial
Patent: 52279
Estimated Expiration: ⤷ Start 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 WIDAPLIK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2018213147 | ⤷ Start Trial | |
| Australia | 2019309329 | ⤷ Start Trial | |
| Australia | 2023274064 | ⤷ Start Trial | |
| Australia | 2025201831 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WIDAPLIK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1003503 | 05C0048 | France | ⤷ Start Trial | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
| 0678503 | C300499 | Netherlands | ⤷ Start Trial | 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 |
| 1915993 | 92315 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
| 1915993 | C300625 | Netherlands | ⤷ Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
