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FDA Orange Book · active-ingredient family

Aliskiren hemifumarate; hydrochlorothiazide

Aliskiren hemifumarate; hydrochlorothiazide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TEKTURNA HCT · NDA 022107

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
TEKTURNA HCTRLD×4NODEN PHARMANDA 022107Jan 18, 2008

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8618172Jul 13, 2028in 2 yr 1 mo
Product

Aliskiren hemifumarate; hydrochlorothiazide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.