FEMHRT Drug Patent Profile
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When do Femhrt patents expire, and when can generic versions of Femhrt launch?
Femhrt is a drug marketed by Apil and is included in one NDA.
The generic ingredient in FEMHRT is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for FEMHRT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FEMHRT |
| What excipients (inactive ingredients) are in FEMHRT? | FEMHRT excipients list |
| DailyMed Link: | FEMHRT at DailyMed |
Recent Clinical Trials for FEMHRT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | N/A |
| Johns Hopkins University | N/A |
| Cedars-Sinai Medical Center | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for FEMHRT
US Patents and Regulatory Information for FEMHRT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-002 | Oct 15, 1999 | DISCN | Yes | 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 FEMHRT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-001 | Jan 14, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Apil | FEMHRT | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 021065-002 | Oct 15, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FEMHRT
See the table below for patents covering FEMHRT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 182795 | Composition useful in the treatment of estrogen deficiencies | ⤷ Try a Trial |
| Australia | 599082 | ⤷ Try a Trial | |
| Canada | 1300017 | PREPARATION POUR PREVENIR L'OSTEOPOROSE (COMPOSITION FOR PREVENTING OSTEOPOROSIS) | ⤷ Try a Trial |
| European Patent Office | 0235090 | COMPOSITION USEFUL IN THE TREATMENT OF ESTROGEN DEFICIENCIES | ⤷ Try a Trial |
| Germany | 3787386 | ⤷ Try a Trial | |
| Denmark | 99987 | ⤷ Try a Trial | |
| Japan | S62205024 | COMPOSITION CONTAINING CERTAIN COMBINATION | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FEMHRT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1380301 | CA 2009 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 15C0050 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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