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Last Updated: April 20, 2024

Methyldopa - Generic Drug Details

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

Methyldopa is the generic ingredient in three branded drugs marketed by Merck, Accord Hlthcare, Chartwell Rx, Duramed Pharms Barr, Halsey, Heritage Pharma, Parke Davis, Pliva, Purepac Pharm, Rising, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, Watson Labs, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hospira, Marsam Pharms Llc, Smith And Nephew, and Teva Parenteral, and is included in fifty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for methyldopa. One supplier is listed for this compound.

Summary for methyldopa

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	57
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	18
Patent Applications:	5,774
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methyldopa
What excipients (inactive ingredients) are in methyldopa?	methyldopa excipients list
DailyMed Link:	methyldopa at DailyMed

See drug prices for methyldopa

Recent Clinical Trials for methyldopa

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of Paraíba	Phase 4
Assiut University	Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2

See all methyldopa clinical trials

Pharmacology for methyldopa

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for methyldopa

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Sympatholytics

US Patents and Regulatory Information for methyldopa

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Glossary

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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
Strides Pharma	METHYLDOPA	methyldopa	TABLET;ORAL	070536-001	Jan 2, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Purepac Pharm	METHYLDOPA	methyldopa	TABLET;ORAL	070750-001	Feb 7, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	METHYLDOPA	methyldopa	TABLET;ORAL	070670-001	Jun 23, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Halsey	METHYLDOPA	methyldopa	TABLET;ORAL	071753-001	Mar 28, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	METHYLDOPATE HYDROCHLORIDE	methyldopate hydrochloride	INJECTABLE;INJECTION	071279-001	Oct 2, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	METHYLDOPA	methyldopa	TABLET;ORAL	070260-001	Jun 24, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for methyldopa

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	ALDOMET	methyldopa	SUSPENSION;ORAL	018389-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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