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EDARBYCLOR Drug Profile
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See Plans and PricingWhich patents cover Edarbyclor, and when can generic versions of Edarbyclor launch?
Edarbyclor is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and fifteen patent family members in forty-three countries.
The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
US ANDA Litigation and Generic Entry Outlook for Edarbyclor
Edarbyclor was eligible for patent challenges on February 25, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 4, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for EDARBYCLOR
| International Patents: | 115 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EDARBYCLOR |
| DailyMed Link: | EDARBYCLOR at DailyMed |
Generic Entry Opportunity Date for EDARBYCLOR
Generic Entry Date for EDARBYCLOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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.
Recent Clinical Trials for EDARBYCLOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 3 |
Pharmacology for EDARBYCLOR
| Drug Class | Angiotensin 2 Receptor Blocker Thiazide-like Diuretic |
| Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
| Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Synonyms for EDARBYCLOR
| Azilsartan kamedoxomil / chlorthalidone |
| Azilsartan kamedoxomil mixture with chlorthalidone |
| Azilsartan medoxomil / chlorthalidone |
| Azilsartan medoxomil mixture with chlorthalidone |
| S900005855 |
US Patents and Regulatory Information for EDARBYCLOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 EDARBYCLOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | Start Trial | Start Trial |
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | Start Trial | Start Trial |
| Arbor Pharms Llc | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EDARBYCLOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20070510 | Start Trial |
| Tunisia | 2011000045 | Start Trial |
| Costa Rica | 20110111 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EDARBYCLOR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1718641 | 91962 | Luxembourg | Start Trial | 91962, EXPIRES: 20261207 |
| 1718641 | 132012902056823 | Italy | Start Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207 |
| 1718641 | 436 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
