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FDA Orange Book · active-ingredient family

Timolol maleate

Timolol maleate is approved as 6 brand and 53 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ISTALOL · NDA 021516

6

Brand (NDA)

53

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, gel forming/drops, solution/drops, tablet

ProductApplicantApplicationTEApproved
ISTALOLRLDBAUSCH AND LOMBNDA 021516AT2Jun 04, 2004
TIMOLOL MALEATERLD×2SANDOZNDA 020963ABOct 21, 1998
TIMOPTIC-XERLD×2BAUSCH AND LOMB INCNDA 020330ABNov 04, 1993
TIMOPTIC IN OCUDOSERLD×2BAUSCH AND LOMB INCNDA 019463AT3Nov 05, 1986
TIMOPTICRLD×2BAUSCH AND LOMB INCNDA 018086AT1Approved Prior to Jan 1, 1982
BLOCADRENRLD×3MERCKNDA 018017—Approved Prior to Jan 1, 1982

Generic (ANDA) products (53)

ProductApplicantApplicationTEApproved
TIMOLOL MALEATE×2SOMERSET THERAPS LLCANDA 210640ABSep 16, 2024
TIMOLOL MALEATECAPLINANDA 218460AT1Aug 07, 2024
TIMOLOL MALEATE×2SOMERSETANDA 217764AT1Jul 03, 2024
TIMOLOL MALEATESOMERSET THERAPS LLCANDA 216653AT2Jul 03, 2024
TIMOLOL MALEATE×2AMNEALANDA 216343—May 23, 2024
TIMOLOL MALEATE×2MICRO LABSANDA 217343AT1May 26, 2023
TIMOLOL MALEATESENTISS PHARMAANDA 217195AT3May 08, 2023
TIMOLOL MALEATEEUGIA PHARMAANDA 213540ABMar 23, 2023
TIMOLOL MALEATE×2DR REDDYSANDA 215733ABSep 22, 2022
TIMOLOL MALEATE×2INGENUS PHARMS LLCANDA 216533AT3Sep 13, 2022
TIMOLOL MALEATEMICRO LABSANDA 216596AT3Sep 07, 2022
TIMOLOL MALEATE×2GLANDANDA 214645ABJun 24, 2022
TIMOLOL MALEATE×2AMRING PHARMSANDA 212592AT3Dec 13, 2021
TIMOLOL MALEATE×2ALEMBICANDA 212942ABOct 22, 2020
TIMOLOL MALEATEEPIC PHARMA LLCANDA 212291AT3Sep 11, 2020
TIMOLOL MALEATE×3RISINGANDA 207556—May 02, 2019
TIMOLOL MALEATEAPOTEXANDA 204936—Apr 17, 2015
TIMOLOL MALEATE×2MANKIND PHARMAANDA 078771AT1Sep 28, 2009
TIMOLOL MALEATE×2FDC LTDANDA 077259AT1Apr 30, 2008
TIMOLOL MALEATEHIKMAANDA 075163—Sep 10, 2002
TIMOLOL MALEATEAPOTEX INCANDA 075411—Sep 08, 2000
TIMOLOL MALEATEAPOTEX INCANDA 075412—Sep 08, 2000
TIMOLOL MALEATEBAUSCH AND LOMBANDA 074778—Mar 25, 1997
TIMOLOL MALEATEBAUSCH AND LOMBANDA 074776—Mar 25, 1997
TIMOLOL MALEATEEPIC PHARMA LLCANDA 074465—Mar 25, 1997
TIMOLOL MALEATEEPIC PHARMA LLCANDA 074515—Mar 25, 1997
TIMOLOL MALEATEEPIC PHARMA LLCANDA 074516—Mar 25, 1997
TIMOLOL MALEATEFOUGERAANDA 074667—Mar 25, 1997
TIMOLOL MALEATEFOUGERAANDA 074668—Mar 25, 1997
TIMOLOL MALEATEPACIFIC PHARMAANDA 074746AT1Mar 25, 1997
TIMOLOL MALEATEPACIFIC PHARMAANDA 074747AT1Mar 25, 1997
TIMOLOL MALEATEPHARMOBEDIENTANDA 074466—Mar 25, 1997
TIMOLOL MALEATESANDOZANDA 074261AT1Apr 28, 1995
TIMOLOL MALEATESANDOZANDA 074262AT1Apr 28, 1995
TIMOLOL MALEATETEVAANDA 072648—Jun 16, 1993
TIMOLOL MALEATETEVAANDA 072649—Jun 16, 1993
TIMOLOL MALEATETEVAANDA 072650—Jun 16, 1993
TIMOLOL MALEATEANI PHARMSANDA 072917—Jul 31, 1991
TIMOLOL MALEATEANI PHARMSANDA 072918—Jul 31, 1991
TIMOLOL MALEATEANI PHARMSANDA 072919—Jul 31, 1991
TIMOLOL MALEATE×3MYLANANDA 072668—Jun 08, 1990
TIMOLOL MALEATEQUANTUM PHARMICSANDA 072466—May 19, 1989
TIMOLOL MALEATEQUANTUM PHARMICSANDA 072467—May 19, 1989
TIMOLOL MALEATEQUANTUM PHARMICSANDA 072468—May 19, 1989
TIMOLOL MALEATECHARTWELL RXANDA 072550—Apr 13, 1989
TIMOLOL MALEATECHARTWELL RXANDA 072551—Apr 13, 1989
TIMOLOL MALEATECHARTWELL RXANDA 072552—Apr 13, 1989
TIMOLOL MALEATEUSL PHARMAANDA 072001—Apr 11, 1989
TIMOLOL MALEATEUSL PHARMAANDA 072002—Apr 11, 1989
TIMOLOL MALEATEUSL PHARMAANDA 072003—Apr 11, 1989
TIMOLOL MALEATEWATSON LABSANDA 072269—Apr 11, 1989
TIMOLOL MALEATEWATSON LABSANDA 072270—Apr 11, 1989
TIMOLOL MALEATEWATSON LABSANDA 072271—Apr 11, 1989

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Timolol maleate — frequently asked questions

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

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