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Last Updated: October 16, 2019

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PRESTALIA Drug Profile

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When do Prestalia patents expire, and when can generic versions of Prestalia launch?

Prestalia is a drug marketed by Adhera and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in forty countries.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

Drug patent expirations by year for PRESTALIA
Generic Entry Opportunity Date for PRESTALIA
Generic Entry Date for PRESTALIA*:
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.

Synonyms for PRESTALIA
1265624-53-0
Amlodipine / perindopril
Amlodipine and perindopril
Amlodipine besylate / with perindopril arginine
Amlodipine besylate mixture with perindopril arginine
Coveram
Perindopril arginine mixture with amlodipine besylate

US Patents and Regulatory Information for PRESTALIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-001 Jan 21, 2015 RX Yes No   See Pricing   See Pricing Y Y   See Pricing
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 RX Yes No   See Pricing   See Pricing Y Y   See Pricing
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-001 Jan 21, 2015 RX Yes No   See Pricing   See Pricing Y Y   See Pricing
>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 PRESTALIA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg ➤ Subscribe   See Pricing

Supplementary Protection Certificates for PRESTALIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C300528 Netherlands   See Pricing 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
0502314 C300478 Netherlands   See Pricing PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0443983 C300445 Netherlands   See Pricing PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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