Is there a generic for Dipivefrin hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dipivefrin hydrochloride, referencing the brand PROPINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dipivefrin hydrochloride?

PROPINE (NDA 018239, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dipivefrin hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Dipivefrin hydrochloride

Dipivefrin hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PROPINE · NDA 018239

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
PROPINE	ALLERGAN	NDA 018239	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
AKPRO	EPIC PHARMA LLC	ANDA 074382	—	Sep 29, 1995
DIPIVEFRIN HYDROCHLORIDE	BAUSCH AND LOMB	ANDA 074188	—	May 19, 1995
DIPIVEFRIN HYDROCHLORIDE	FALCON PHARMS	ANDA 073636	—	Jun 30, 1994

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.

Dipivefrin hydrochloride — frequently asked questions

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

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