Progesterone - Generic Drug Details
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What are the generic drug 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: | 1,134 |
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 |
---|---|
Instituto Valenciano de Infertilidad, IVI VALENCIA | N/A |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 3 |
Lauren Whitehurst | Phase 3 |
Pharmacology for progesterone
Drug Class | Progesterone |
Medical Subject Heading (MeSH) Categories for progesterone
Anatomical Therapeutic Chemical (ATC) Classes for progesterone
US Patents and Regulatory Information for progesterone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sofgen Pharms | PROGESTERONE | progesterone | CAPSULE;ORAL | 200456-002 | Sep 28, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sofgen Pharms | PROGESTERONE | progesterone | CAPSULE;ORAL | 200456-001 | Sep 28, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | PROGESTERONE | progesterone | CAPSULE;ORAL | 208801-002 | Feb 28, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Eugia Pharma | PROGESTERONE | progesterone | CAPSULE;ORAL | 211285-002 | Oct 26, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for progesterone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for progesterone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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. | ⤷ Sign Up |
New Zealand | 587758 | MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USES THEREOF | ⤷ Sign Up |
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.) | ⤷ Sign Up |
Taiwan | 200938204 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for progesterone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2782584 | 21C1058 | France | ⤷ Sign Up | 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 | 301153 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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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