Is there a generic for Metipranolol hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Metipranolol hydrochloride, referencing the brand OPTIPRANOLOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Metipranolol hydrochloride?

OPTIPRANOLOL (NDA 019907, BAUSCH AND LOMB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Metipranolol hydrochloride are approved?

Metipranolol hydrochloride is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Metipranolol hydrochloride

Metipranolol hydrochloride: 1 brand, 1 generic; first approved Dec 29, 1989; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

OPTIPRANOLOLRLD

BAUSCH AND LOMBNDA 0199071989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Abbreviated applications

Generic (ANDA) products (1)

METIPRANOLOL

SANDOZANDA 0757202001

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Dec 29, 1989

37 yr 1 mo ago

Most recent approval

Aug 06, 2001

25 yr 4 mo ago

Approvals span 1989–2001 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Metipranolol hydrochloride — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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