BENZONATATE - Generic Drug Details

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What are the generic sources for benzonatate and what is the scope of freedom to operate?

Benzonatate is the generic ingredient in two branded drugs marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, Zydus Pharms Usa, and Pfizer, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for benzonatate. Forty-four suppliers are listed for this compound.

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Pfizer	Phase 1

Sponsor

Phase

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 1

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 3

Pfizer

Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage Pharms Labs	BENZONATATE	benzonatate	CAPSULE;ORAL	040682-002	Jul 30, 2007	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mikart	BENZONATATE	benzonatate	CAPSULE;ORAL	040851-002	Nov 9, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	BENZONATATE	benzonatate	CAPSULE;ORAL	091133-002	Jul 30, 2015	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	BENZONATATE	benzonatate	CAPSULE;ORAL	210562-002	Nov 9, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Thepharmanetwork Llc	BENZONATATE	benzonatate	CAPSULE;ORAL	040627-001	Mar 30, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa	BENZONATATE	benzonatate	CAPSULE;ORAL	040597-001	Jun 8, 2007	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	4
Patent Applications:	3,270
Drug Prices:	Drug price trends for BENZONATATE
Drug Sales Revenues:	Drug sales revenues for BENZONATATE
What excipients (inactive ingredients) are in BENZONATATE?	BENZONATATE excipients list
DailyMed Link:	BENZONATATE at DailyMed

Drug Class	Non-narcotic Antitussive
Physiological Effect	Decreased Tracheobronchial Stretch Receptor Activity