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 |
Recent Clinical Trials for progesterone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 4 |
Fundación Santiago Dexeus Font | Phase 3 |
Fayoum University | N/A |
Pharmacology for progesterone
Drug Class | Progesterone |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Am Regent | PROGESTERONE | progesterone | INJECTABLE;INJECTION | 090845-001 | Jun 22, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Allergan | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | RX | Yes | Yes | ⤷ 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 | |||
Dr Reddys | PROGESTERONE | progesterone | CAPSULE;ORAL | 208801-001 | Feb 28, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ferring Pharms Inc | MILPROSA | progesterone | SYSTEM;VAGINAL | 201110-001 | Apr 29, 2020 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bionpharma | PROGESTERONE | progesterone | CAPSULE;ORAL | 200900-002 | Aug 16, 2013 | AB | RX | No | 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 |
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 |
International Patents for progesterone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 611268 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof | ⤷ Try a Trial |
Eurasian Patent Organization | 031017 | СПОСОБ ПОДДЕРЖАНИЯ ИЛИ ЗАМЕЩЕНИЯ ФАЗЫ ЖЁЛТОГО ТЕЛА (METHOD FOR SUPPORT OR SUBSTITUTION OF YELLOW BODY PHASE) | ⤷ Try a Trial |
China | 104146948 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof | ⤷ Try a Trial |
Taiwan | 201526898 | Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof | ⤷ Try a Trial |
South Korea | 20140048321 | MONOLITHIC INTRAVAGINAL RINGS COMPRISING PROGESTERONE AND METHODS OF MAKING AND USE THEREOF | ⤷ Try a Trial |
Japan | 2011510984 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for progesterone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 |
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 | 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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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