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Progesterone - Generic Drug Details

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

Progesterone is the generic ingredient in five branded drugs marketed by Bionpharma Inc, Dr Reddys Labs Inc, Allergan Sales Llc, Fresenius Kabi Usa, Teva Pharms, Hikma Farmaceutica, Lilly, Luitpold, Alza, Sofgen Pharms, Ferring, Actavis Labs Ut Inc, and Virtus Pharms, and is included in thirteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eleven patent family members in nine countries.

There are fifty-one drug master file entries for progesterone. Twenty-four suppliers are listed for this compound.

Summary for Generic Name: progesterone

Tradenames:5
Patents:4
Applicants:13
NDAs:13
Drug Master File Entries: see list51
Suppliers / Packagers: see list24
Bulk Api Vendors: see list69
Clinical Trials: see list345
Patent Applications: see list9,707
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:progesterone at DailyMed

Pharmacology for Ingredient: progesterone

Ingredient-typeProgesterone
Drug ClassProgesterone
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc
PROGESTERONE
progesterone
INJECTABLE;INJECTION017362-002Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
Sofgen Pharms
PROGESTERONE
progesterone
CAPSULE;ORAL200456-001Sep 28, 2012RXNoNo► Subscribe► Subscribe
Virtus Pharms
PROMETRIUM
progesterone
CAPSULE;ORAL019781-001May 14, 1998RXYesNo► Subscribe► Subscribe
Lilly
PROGESTERONE
progesterone
INJECTABLE;INJECTION009238-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Virtus Pharms
PROMETRIUM
progesterone
CAPSULE;ORAL019781-003Oct 15, 1999DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: progesterone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-001Jul 31, 19974,615,697► Subscribe
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-002Jul 31, 19975,543,150► Subscribe
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-001Jul 31, 19975,543,150► Subscribe
Allergan Sales Llc
CRINONE
progesterone
GEL;VAGINAL020701-002Jul 31, 19974,615,697► Subscribe
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International Patent Family for Ingredient: progesterone

Country Document Number Estimated Expiration
TaiwanI239249► Subscribe
Japan2002529494► Subscribe
Israel127129► Subscribe
Australia1176200► Subscribe
European Patent Office1131052► 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: PROGESTERONE

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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