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 Inc, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Virtus Pharms, Allergan, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, Alza, Ferring, and Ferring Pharms Inc, and is included in nineteen 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-two suppliers are listed for this compound.
Summary for progesterone
International Patents: | 53 |
US Patents: | 3 |
Tradenames: | 6 |
Applicants: | 17 |
NDAs: | 19 |
Drug Master File Entries: | 57 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 1,094 |
Patent Applications: | 7,313 |
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 |
Recent Clinical Trials for progesterone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 3 |
First People's Hospital of Foshan | Phase 3 |
Shenzhen People's Hospital | Phase 3 |
Pharmacology for progesterone
Drug Class | Progesterone |
Medical Subject Heading (MeSH) Categories for progesterone
US Patents and Regulatory Information for progesterone
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 | See Plans and Pricing | See Plans and Pricing |
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | See Plans and Pricing | See Plans and Pricing |
Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | See Plans and Pricing | See Plans and Pricing |
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | See Plans and Pricing | See Plans and Pricing |
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | See Plans and Pricing | See Plans and Pricing |
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | See Plans and Pricing | See Plans and Pricing |
Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for progesterone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2010008545 | 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.) | See Plans and Pricing |
Japan | 6124411 | See Plans and Pricing | |
Denmark | 2359807 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2009099586 | See Plans and Pricing | |
Slovenia | 2359807 | See Plans and Pricing | |
Chile | 2009000242 | Anillo monolitico intravaginal para tratar un defecto en la fase lutea, que comprende progesterona, un elastomero de polisiloxano y un aceite mineral, estando la progesterona dispersa homogeneamente en el elastomero de polisiloxano y procedimiento para fabricarlo. | See Plans and Pricing |
Taiwan | 201526898 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for progesterone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0113964 | 97C0037 | Belgium | See Plans and Pricing | 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 | See Plans and Pricing | 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 | 301153 | Netherlands | See Plans and Pricing | 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 | 2021C/558 | Belgium | See Plans and Pricing | 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 |
2782584 | LUC00245 | Luxembourg | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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