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Magnesium sulfate anhydrous; potassium sulfate; sodium sulfate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for magnesium sulfate anhydrous; potassium sulfate; sodium sulfate?

Magnesium sulfate anhydrous; potassium sulfate; sodium sulfate is the generic ingredient in two branded drugs marketed by Novel Labs Inc and Braintree Labs, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventeen patent family members in thirteen countries.

There are one hundred and thirty-one drug master file entries for magnesium sulfate anhydrous; potassium sulfate; sodium sulfate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: magnesium sulfate anhydrous; potassium sulfate; sodium sulfate

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list131
Suppliers / Packagers: see list1
Clinical Trials: see list1,409
Drug Prices:see low prices
DailyMed Link:magnesium sulfate anhydrous; potassium sulfate; sodium sulfate at DailyMed

Tentative approvals for MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION;ORAL1.6GM/BOT; 3.13GM/BOT; 17.5GM/BOT
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Braintree Labs
SUPREP BOWEL PREP KIT
magnesium sulfate anhydrous; potassium sulfate; sodium sulfate
SOLUTION;ORAL022372-001Aug 5, 2010RXYesYes6,946,149► SubscribeY ► Subscribe
Novel Labs Inc
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
magnesium sulfate anhydrous; potassium sulfate; sodium sulfate
SOLUTION;ORAL202511-001Feb 23, 2017RXNoNo► Subscribe► Subscribe
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International Patent Family for Ingredient: magnesium sulfate anhydrous; potassium sulfate; sodium sulfate

Country Document Number Estimated Expiration
Denmark2292244► Subscribe
Austria457172► Subscribe
Spain2441890► Subscribe
Germany60331220► Subscribe
Denmark2233147► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/048Ireland► SubscribePRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
90006-4Sweden► SubscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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