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FDA Orange Book · active-ingredient family

Empagliflozin; linagliptin

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

Reference-listed drug:GLYXAMBI · NDA 206073

1

Brand (NDA)

0

Generics (ANDA)

27

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
GLYXAMBIRLD×2BOEHRINGER INGELHEIMNDA 206073—Jan 30, 2015

Listed patents (27)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8883805Nov 26, 20257 mo ago
Product
8883805*PEDMay 26, 202624 d ago
7713938Apr 15, 2027in 10 mo
SubstanceProduct
9173859May 04, 2027in 11 mo
ProductU-1772Delisted
8673927May 04, 2027in 11 mo
U-1652Delisted
11033552May 04, 2027in 11 mo
Product
12178819May 04, 2027in 11 mo
Product
7713938*PEDOct 15, 2027in 1 yr 4 mo
8673927*PEDNov 04, 2027in 1 yr 5 mo
11033552*PEDNov 04, 2027in 1 yr 5 mo
7579449Aug 01, 2028in 2 yr 2 mo
Substance
7579449*PEDFeb 01, 2029in 2 yr 8 mo
8551957Oct 14, 2029in 3 yr 4 mo
ProductU-1651
12115179Feb 11, 2030in 3 yr 8 mo
U-4023
8551957*PEDApr 14, 2030in 3 yr 11 mo
12115179*PEDAug 11, 2030in 4 yr 2 mo
10258637Apr 03, 2034in 7 yr 11 mo
U-2290
12433906Apr 03, 2034in 7 yr 11 mo
U-4304
11090323Apr 03, 2034in 7 yr 11 mo
U-3191
11833166Apr 03, 2034in 7 yr 11 mo
U-3776
9949998Jun 11, 2034in 8 yr 1 mo
U-2290
10258637*PEDOct 03, 2034in 8 yr 5 mo
12433906*PEDOct 03, 2034in 8 yr 5 mo
11833166*PEDOct 03, 2034in 8 yr 5 mo
11090323*PEDOct 03, 2034in 8 yr 5 mo
12364700Jun 08, 2037in 11 yr 2 mo
U-4224
12364700*PEDDec 08, 2037in 11 yr 8 mo

Empagliflozin; linagliptin — 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.

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