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Medroxyprogesterone acetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for medroxyprogesterone acetate?

Medroxyprogesterone acetate is the generic ingredient in seven branded drugs marketed by Sandoz, Duramed Pharms Barr, Esi , Pharmacia And Upjohn, Amarin Pharms, Teva Pharms Usa, Barr, Usl Pharma, and Solvay, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-seven patent family members in twenty-eight countries.

There are nineteen drug master file entries for medroxyprogesterone acetate. Twenty-five suppliers are listed for this compound.

Summary for Generic Name: medroxyprogesterone acetate

Tradenames:7
Patents:2
Applicants:9
NDAs:15
Drug Master File Entries: see list19
Suppliers / Packagers: see list25
Bulk Api Vendors: see list40
Clinical Trials: see list448
Patent Applications: see list7,102
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:medroxyprogesterone acetate at DailyMed

Pharmacology for Ingredient: medroxyprogesterone acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
PROVERA
medroxyprogesterone acetate
TABLET;ORAL011839-003Approved Prior to Jan 1, 1982RXYesNo► Subscribe► Subscribe
Duramed Pharms Barr
MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate
TABLET;ORAL040311-001Dec 1, 1999DISCNNoNo► Subscribe► Subscribe
Pharmacia And Upjohn
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION012541-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
Pharmacia And Upjohn
DEPO-SUBQ PROVERA 104
medroxyprogesterone acetate
INJECTABLE;SUBCUTANEOUS021583-001Dec 17, 2004RXYesYes6,495,534► SubscribeY ► Subscribe
Esi
CYCRIN
medroxyprogesterone acetate
TABLET;ORAL089386-001Sep 9, 1987DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: medroxyprogesterone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION012541-002Approved Prior to Jan 1, 19824,038,389► Subscribe
Pharmacia And Upjohn
DEPO-PROVERA
medroxyprogesterone acetate
INJECTABLE;INJECTION012541-003Approved Prior to Jan 1, 19824,038,389► Subscribe
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International Patent Family for Ingredient: medroxyprogesterone acetate

Country Document Number Estimated Expiration
Peru13222001► Subscribe
South Korea20030020280► Subscribe
South Korea100828957► Subscribe
Austria313316► Subscribe
Czech Republic20023750► 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: MEDROXYPROGESTERONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0037Belgium► SubscribePRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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