DROXIDOPA - Generic Drug Details

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

Droxidopa is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, Lupin Pharms, Msn Pharms Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Pharms Usa Inc, Upsher Smith Labs, Yampa, Zydus Pharms, and Lundbeck Na Ltd, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for droxidopa. Sixteen suppliers are listed for this compound.

Sponsor

Phase

Kessler Foundation

Phase 4

Loma Linda University

Phase 2

H. Lundbeck A/S

Phase 2

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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
Aurobindo Pharma Ltd	DROXIDOPA	droxidopa	CAPSULE;ORAL	214387-002	Feb 18, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	DROXIDOPA	droxidopa	CAPSULE;ORAL	211818-001	Feb 18, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	DROXIDOPA	droxidopa	CAPSULE;ORAL	213162-002	Feb 18, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	DROXIDOPA	droxidopa	CAPSULE;ORAL	211818-002	Feb 18, 2021	AB	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:	17
NDAs:	17
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	34
Patent Applications:	652
Drug Prices:	Drug price trends for DROXIDOPA
What excipients (inactive ingredients) are in DROXIDOPA?	DROXIDOPA excipients list
DailyMed Link:	DROXIDOPA at DailyMed