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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Fuji
McKinsey
Boehringer Ingelheim
Colorcon
Fish and Richardson
Mallinckrodt
Novartis
Federal Trade Commission

Generated: December 16, 2017

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Progesterone - Generic Drug Details

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What are the generic drug sources for progesterone and what is the scope of progesterone patent protection?

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

Progesterone has twelve patent family members in nine countries and one supplementary protection certificate in one country.

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

Pharmacology for progesterone

Ingredient-typeProgesterone
Drug ClassProgesterone

Medical Subject Heading (MeSH) Categories for progesterone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz IncPROGESTERONEprogesteroneCAPSULE;ORAL205229-002Oct 20, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sofgen PharmsPROGESTERONEprogesteroneCAPSULE;ORAL200456-001Sep 28, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz IncPROGESTERONEprogesteroneCAPSULE;ORAL205229-001Oct 20, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs IncPROGESTERONEprogesteroneCAPSULE;ORAL208801-002Feb 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sofgen PharmsPROGESTERONEprogesteroneCAPSULE;ORAL200456-002Sep 28, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs IncPROGESTERONEprogesteroneCAPSULE;ORAL208801-001Feb 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
FerringENDOMETRINprogesteroneINSERT;VAGINAL022057-001Jun 21, 2007RXYesYes► Subscribe► Subscribe► Subscribe
Amneal Pharms NyPROGESTERONEprogesteroneCAPSULE;ORAL207724-002Sep 7, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva PharmsPROGESTERONEprogesteroneCAPSULE;ORAL202121-001Feb 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Bionpharma IncPROGESTERONEprogesteroneCAPSULE;ORAL200900-001Aug 16, 2013ABRXNoNo► Subscribe► 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 LlcCRINONEprogesteroneGEL;VAGINAL020701-001Jul 31, 1997► Subscribe► Subscribe
Allergan Sales LlcCRINONEprogesteroneGEL;VAGINAL020701-002Jul 31, 1997► Subscribe► Subscribe
Allergan Sales LlcCRINONEprogesteroneGEL;VAGINAL020701-002Jul 31, 1997► Subscribe► Subscribe
Allergan Sales LlcCRINONEprogesteroneGEL;VAGINAL020701-001Jul 31, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: progesterone

Country Document Number Estimated Expiration
European Patent Office2386291► Subscribe
Spain2390959► Subscribe
Israel127129► Subscribe
European Patent Office1131052► Subscribe
Canada2568823► Subscribe
World Intellectual Property Organization (WIPO)0028970► Subscribe
TaiwanI239249► Subscribe
Australia1176200► Subscribe
Japan4667601► Subscribe
Japan2002529494► 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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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Healthtrust
Fuji
McKinsey
Federal Trade Commission
Merck
Farmers Insurance
US Department of Justice
Colorcon

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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