Assyro AI

FDA Orange Book · active-ingredient family

Dexamethasone

Dexamethasone is approved as 11 brand and 53 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HEMADY · NDA 211379

11

Brand (NDA)

53

Generics (ANDA)

12

Listed patents

2

Exclusivity periods

Brand (NDA) products · aerosol, concentrate, elixir, gel, implant, insert, solution, suspension, suspension/drops, tablet

ProductApplicantApplicationTEApproved
HEMADYRLDDEXCELNDA 211379—Oct 03, 2019
DEXTENZARLDOCULAR THERAPEUTIXNDA 208742—Nov 30, 2018
DEXYCU KITRLDEYEPOINT PHARMSNDA 208912—Feb 09, 2018
OZURDEXRLDABBVIENDA 022315—Jun 17, 2009
DECASPRAYRLDMERCKNDA 012731—Approved Prior to Jan 1, 1982
MAXIDEXRLDHARROW EYENDA 013422—Approved Prior to Jan 1, 1982
DECADRONRLD×6MERCKNDA 011664—Approved Prior to Jan 1, 1982
DECADRONMERCKNDA 012376—Approved Prior to Jan 1, 1982
HEXADROLASPEN GLOBAL INCNDA 012674—Approved Prior to Jan 1, 1982
DECADERMMERCKNDA 013538—Approved Prior to Jan 1, 1982
HEXADROL×4ASPEN GLOBAL INCNDA 012675—Approved Prior to Jan 1, 1982

Generic (ANDA) products (53)

ProductApplicantApplicationTEApproved
DEXAMETHASONE×7COREPHARMAANDA 218372ABSep 17, 2024
DEXAMETHASONEZYDUS LIFESCIENCESANDA 216284ABMay 09, 2024
DEXAMETHASONE×5ZYDUS LIFESCIENCESANDA 216282ABFeb 07, 2024
DEXAMETHASONEZYDUS LIFESCIENCESANDA 216283ABFeb 07, 2024
DEXAMETHASONE×5NOVITIUM PHARMAANDA 215604ABOct 05, 2023
DEXAMETHASONE×7APOTEXANDA 217695ABAug 23, 2023
DEXAMETHASONENOVITIUM PHARMAANDA 217696ABMay 09, 2023
DEXAMETHASONEBIONPHARMAANDA 217538ABApr 26, 2023
DEXAMETHASONE×2BIONPHARMAANDA 217001ABApr 19, 2023
DEXAMETHASONEAMNEALANDA 216295ABSep 08, 2022
DEXAMETHASONE×2AMNEALANDA 215106ABOct 14, 2021
DEXAMETHASONEPHARMOBEDIENTANDA 201270ABJul 17, 2017
DEXAMETHASONERISINGANDA 090891AAJul 12, 2011
DEXAMETHASONECHARTWELL MOLECULARANDA 091188AAMay 11, 2011
DEXAMETHASONEBAUSCHANDA 040700—Aug 15, 2008
DEXAMETHASONEWATSON LABSANDA 089170—May 09, 1989
DEXAMETHASONEALPHARMA US PHARMSANDA 088997—Oct 10, 1986
DEXAMETHASONE INTENSOLRLDHIKMAANDA 088252—Sep 01, 1983
DEXAMETHASONERLDHIKMAANDA 088248—Sep 01, 1983
DEXAMETHASONERLDPHARMOBEDIENT CNSLTGANDA 088254—Jul 27, 1983
DEXAMETHASONE×4ALVOGENANDA 088481BPApr 28, 1983
DEXAMETHASONEKEY THERAPANDA 088237—Apr 28, 1983
DEXAMETHASONEPANGEAANDA 088149—Apr 28, 1983
AEROSEB-DEXALLERGAN HERBERTANDA 083296—Approved Prior to Jan 1, 1982
DEXAMETHASONEKANCHAN HLTHCAREANDA 084754AAApproved Prior to Jan 1, 1982
DEXAMETHASONECHARTWELL RXANDA 085456—Approved Prior to Jan 1, 1982
DEXAMETHASONERLD×7HIKMAANDA 084612ABApproved Prior to Jan 1, 1982
DEXAMETHASONEIMPAX LABSANDA 085376—Approved Prior to Jan 1, 1982
DEXAMETHASONEPHOENIX LABS NYANDA 083806—Approved Prior to Jan 1, 1982
DEXAMETHASONE×2PRASCOANDA 080399—Approved Prior to Jan 1, 1982
DEXAMETHASONEPVT FORMANDA 083420—Approved Prior to Jan 1, 1982
DEXAMETHASONEROXANEANDA 084614—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084013—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084764—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084084—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084766—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084081—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084765—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084086—Approved Prior to Jan 1, 1982
DEXAMETHASONESUN PHARM INDUSTRIESANDA 084763—Approved Prior to Jan 1, 1982
DEXAMETHASONEUPSHER SMITHANDA 087534—Approved Prior to Jan 1, 1982
DEXAMETHASONEUPSHER SMITHANDA 087533—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 085455—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 085458—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 080968—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 084457—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 085818—Approved Prior to Jan 1, 1982
DEXAMETHASONEWATSON LABSANDA 085840—Approved Prior to Jan 1, 1982
DEXAMETHASONEWHITEWORTH TOWN PLSNANDA 084327—Approved Prior to Jan 1, 1982
DEXONE 0.5SOLVAYANDA 084991—Approved Prior to Jan 1, 1982
DEXONE 0.75SOLVAYANDA 084993—Approved Prior to Jan 1, 1982
DEXONE 1.5SOLVAYANDA 084990—Approved Prior to Jan 1, 1982
DEXONE 4SOLVAYANDA 084992—Approved Prior to Jan 1, 1982

Marketing exclusivity (2)

  • NPPNew patient population exclusivity (3 years)

    Apr 07, 2028

    in 1 yr 10 mo

  • ODE-271Orphan-drug exclusivity (7 years)

    Oct 03, 2026

    in 4 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8563027Feb 12, 2030in 3 yr 8 mo
U-2487
8409606May 14, 2030in 4 yr
Product
10799642May 11, 2032in 6 yr
Product
10028965May 23, 2034in 8 yr 1 mo
U-2340
10159683May 23, 2034in 8 yr 1 mo
Product
10022502Jun 22, 2034in 8 yr 2 mo
U-2340
12150896Oct 07, 2036in 10 yr 5 mo
U-1680
11458041Nov 16, 2037in 11 yr 7 mo
U-1680
11304961Dec 18, 2037in 11 yr 8 mo
ProductU-3344
10537585Dec 18, 2037in 11 yr 8 mo
Product
11097061Jun 23, 2039in 13 yr 2 mo
ProductU-3418
12144889Apr 26, 2041in 15 yr 1 mo
U-1680

Dexamethasone — frequently asked questions

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

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