Details for New Drug Application (NDA): 205003
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NDA 205003 describes PRESTALIA, which is a drug marketed by Adhera and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PRESTALIA profile page.
The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.
The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.
Summary for 205003
| Tradename: | PRESTALIA |
| Applicant: | Adhera |
| Ingredient: | amlodipine besylate; perindopril arginine |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205003
Generic Entry Date for 205003*:
Constraining patent/regulatory exclusivity:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE;3.5MG | ||||
| Approval Date: | Jan 21, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 5, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;7MG | ||||
| Approval Date: | Jan 21, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 5, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;14MG | ||||
| Approval Date: | Jan 21, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 5, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
Expired US Patents for NDA 205003
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-001 | Jan 21, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-003 | Jan 21, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-002 | Jan 21, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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