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Progesterone - Generic Drug Details
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This ingredient has eleven patent family members in nine countries.
There are forty-nine drug master file entries for progesterone. Twenty-one suppliers are listed for this compound.
Summary for Generic Name: progesterone
| Tradenames: | 5 |
| Patents: | 3 |
| Applicants: | 11 |
| NDAs: | 12 |
| Drug Master File Entries: see list | 49 |
| Suppliers / Packaging: see list | 21 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: progesterone
| Ingredient-type | Progesterone |
| Drug Class | Progesterone |
Clinical Trials for: progesterone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | PROGESTERONE | progesterone | CAPSULE;ORAL | 202121-001 | Feb 29, 2012 | RX | No | ||||||||||||||||||||||
Ferring | ENDOMETRIN | progesterone | INSERT;VAGINAL | 022057-001 | Jun 21, 2007 | RX | Yes | 7,393,543 | Nov 17, 2019 | Y | |||||||||||||||||||
Alza | PROGESTASERT | progesterone | INSERT, EXTENDED RELEASE;INTRAUTERINE | 017553-001 | Approved Prior to Jan 1, 1982 | DISCN | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: progesterone
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | 4,615,697 | <disabled> | ||||||||||||||||||||||
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | 5,543,150 | <disabled> | ||||||||||||||||||||||
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | 4,615,697 | <disabled> | ||||||||||||||||||||||
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International Patent Family for Ingredient: progesterone
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2002529494 | <disabled in preview> | |||||||||||||||||||||||||||
| Israel | 127129 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 1131052 | <disabled in preview> | |||||||||||||||||||||||||||
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0037 | Belgium | <disabled> | PRODUCT 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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