Is there a generic for Pyridostigmine bromide?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Pyridostigmine bromide, referencing the brand MESTINON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Pyridostigmine bromide?

MESTINON (NDA 009830, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Pyridostigmine bromide?

The Orange Book lists 9 patents against Pyridostigmine bromide products, with the earliest listed expiry in 2038. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Pyridostigmine bromide are approved?

Pyridostigmine bromide is approved in the following dosage forms: injectable, syrup, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Pyridostigmine bromide

Pyridostigmine bromide is approved as 7 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MESTINON · NDA 009830

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, syrup, tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
MESTINONRLD	BAUSCH	NDA 009830	AP	Approved Prior to Jan 1, 1982
MESTINONRLD	BAUSCH	NDA 015193	AA	Approved Prior to Jan 1, 1982
MESTINONRLD	BAUSCH	NDA 011665	AB	Approved Prior to Jan 1, 1982
MESTINONRLD	BAUSCH	NDA 009829	AB	Approved Prior to Jan 1, 1982
PYRIDOSTIGMINE BROMIDE	AMNEAL	NDA 217604	—	Oct 04, 2024
PYRIDOSTIGMINE BROMIDE	US ARMY	NDA 020414	—	Feb 05, 2003
REGONOL	SANDOZ	NDA 017398	AP	Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

Product	Applicant	Application	TE	Approved
PYRIDOSTIGMINE BROMIDE	MSN	ANDA 216512	AA	Sep 21, 2023
PYRIDOSTIGMINE BROMIDE×2	IMPAX LABS	ANDA 040502	AB	Jun 28, 2022
PYRIDOSTIGMINE BROMIDE	MILLA PHARMS	ANDA 212405	AA	Apr 19, 2022
PYRIDOSTIGMINE BROMIDE	AMNEAL	ANDA 212702	AA	Jan 10, 2020
PYRIDOSTIGMINE BROMIDE	RISING	ANDA 208797	AA	Jan 09, 2020
PYRIDOSTIGMINE BROMIDE×2	MLV	ANDA 211181	AB	May 14, 2019
PYRIDOSTIGMINE BROMIDE	NOVITIUM PHARMA	ANDA 211694	AA	Mar 08, 2019
PYRIDOSTIGMINE BROMIDE	RISING	ANDA 205464	AB	Aug 15, 2017
PYRIDOSTIGMINE BROMIDE	IMPAX LABS INC	ANDA 203184	—	Sep 15, 2015
PYRIDOSTIGMINE BROMIDE	ALVOGEN	ANDA 204737	AB	Jun 26, 2015
PYRIDOSTIGMINE BROMIDE	ZYDUS PHARMS	ANDA 205650	AB	Jun 22, 2015
PYRIDOSTIGMINE BROMIDE×2	ANI PHARMS	ANDA 040512	—	Jul 20, 2005
PYRIDOSTIGMINE BROMIDE	IMPAX LABS INC	ANDA 040457	—	Dec 26, 2002
PYRIDOSTIGMINE BROMIDE	SOLVAY	ANDA 089572	—	Nov 27, 1990

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11478425	Jun 18, 2038	in 12 yr 2 mo	ProductU-4012
12042559	Jun 18, 2038	in 12 yr 2 mo	Product
10925833	Jun 18, 2038	in 12 yr 2 mo	Product
12233166	Jun 18, 2038	in 12 yr 2 mo	Product
10987311	Jun 18, 2038	in 12 yr 2 mo	Product
10881617	Jun 18, 2038	in 12 yr 2 mo	Product
11666536	Jun 18, 2038	in 12 yr 2 mo	Product
11911515	Jun 18, 2038	in 12 yr 2 mo	Product
11229606	Jun 18, 2038	in 12 yr 2 mo	Product

Pyridostigmine bromide — frequently asked questions

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

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