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Generated: July 22, 2017
What are the generic drug sources for progesterone and what is the scope of progesterone patent protection?
Progesterone is the generic ingredient in five branded drugs marketed by Bionpharma Inc, Dr Reddys Labs Inc, Allergan Sales Llc, Fresenius Kabi Usa, Teva Pharms, Hikma Farmaceutica, Lilly, Luitpold, Alza, Sofgen Pharms, Ferring, Actavis Labs Ut Inc, and Virtus Pharms, and is included in thirteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 4 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: see list | 52 |
| Suppliers / Packagers: see list | 23 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 733 |
| Patent Applications: see list | 9,870 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | progesterone at DailyMed |
| Ingredient-type | Progesterone |
| Drug Class | Progesterone |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | PROGESTERONE | progesterone | CAPSULE;ORAL | 202121-001 | Feb 29, 2012 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Virtus Pharms | PROMETRIUM | progesterone | CAPSULE;ORAL | 019781-002 | Oct 15, 1999 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Luitpold | PROGESTERONE | progesterone | INJECTABLE;INJECTION | 090845-001 | Jun 22, 2009 | AO | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Actavis Labs Ut Inc | PROGESTERONE | progesterone | INJECTABLE;INJECTION | 017362-002 | Approved Prior to Jan 1, 1982 | AO | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Dr Reddys Labs Inc | PROGESTERONE | progesterone | CAPSULE;ORAL | 208801-001 | Feb 28, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | 4,615,697 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-002 | Jul 31, 1997 | 5,543,150 | ► Subscribe | ||||||||||||||||||||||
Allergan Sales Llc | CRINONE | progesterone | GEL;VAGINAL | 020701-001 | Jul 31, 1997 | 5,543,150 | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2386291 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2011026335 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2568823 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 127129 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1131052 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0037 | Belgium | ► Subscribe | 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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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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