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Last Updated: April 24, 2024

Progesterone - Generic Drug Details


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

Progesterone is the generic ingredient in six branded drugs marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Virtus, Allergan, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in twenty NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Progesterone has fifty-three patent family members in twenty-five countries.

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

Summary for progesterone
International Patents:53
US Patents:3
Tradenames:6
Applicants:18
NDAs:20
Drug Master File Entries: 57
Finished Product Suppliers / Packagers: 25
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 1,115
Patent Applications: 7,265
Formulation / Manufacturing:see details
Drug Prices: Drug price trends for progesterone
Drug Sales Revenues: Drug sales revenues for progesterone
What excipients (inactive ingredients) are in progesterone?progesterone excipients list
DailyMed Link:progesterone at DailyMed
Drug Prices for progesterone

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Drug Sales Revenue Trends for progesterone

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Recent Clinical Trials for progesterone

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

SponsorPhase
Fayoum UniversityN/A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4
Fundación Santiago Dexeus FontPhase 3

See all progesterone clinical trials

Pharmacology for progesterone
Drug ClassProgesterone
Medical Subject Heading (MeSH) Categories for progesterone
Progestins

US Patents and Regulatory Information for progesterone

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc MILPROSA progesterone SYSTEM;VAGINAL 201110-001 Apr 29, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly PROGESTERONE progesterone INJECTABLE;INJECTION 009238-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed PROGESTERONE progesterone CAPSULE;ORAL 205229-001 Oct 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma PROGESTERONE progesterone CAPSULE;ORAL 211285-001 Oct 26, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed PROGESTERONE progesterone CAPSULE;ORAL 205229-002 Oct 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Ut Inc PROGESTERONE progesterone INJECTABLE;INJECTION 017362-002 Approved Prior to Jan 1, 1982 DISCN Yes 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

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Expired US Patents for progesterone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Try a Trial ⤷  Try a Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-002 Jul 31, 1997 ⤷  Try a Trial ⤷  Try a Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-002 Jul 31, 1997 ⤷  Try a Trial ⤷  Try a Trial
Allergan CRINONE progesterone GEL;VAGINAL 020701-001 Jul 31, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Try a Trial ⤷  Try a Trial
Ferring ENDOMETRIN progesterone INSERT;VAGINAL 022057-001 Jun 21, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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International Patents for progesterone

Country Patent Number Title Estimated Expiration
Singapore 187529 MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF ⤷  Try a Trial
Israel 221988 טבעות מונוליטיות למתן נרתיקי המכילות פרוגסטרון, שיטות להכנתן ושימושים בהן (Monolithic intravaginal rings comprising progesterone and methods of making and using the same) ⤷  Try a Trial
Spain 2645630 ⤷  Try a Trial
China 104146948 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof ⤷  Try a Trial
Canada 2713943 ANNEAUX INTRAVAGINAUX MONOLITHIQUES COMPRENANT DE LA PROGESTERONE ; PROCEDES DE FABRICATION ET UTILISATIONS (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF) ⤷  Try a Trial
Mexico 337634 ANILLOS INTRAVAGINALES MONOLITICOS QUE COMPRENDEN PROGESTERONA Y METODOS DE MANUFACTURA Y USO DE LOS MISMOS. (MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for progesterone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2782584 301153 Netherlands ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
2782584 LUC00245 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
0113964 97C0037 Belgium ⤷  Try a Trial PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2782584 132021000000197 Italy ⤷  Try a Trial PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584 21C1058 France ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2782584 2021C/558 Belgium ⤷  Try a Trial PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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