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ANGELIQ Drug Profile
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When do Angeliq patents expire, and when can generic versions of Angeliq launch?
Angeliq is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has twenty-two patent family members in seventeen countries.
The generic ingredient in ANGELIQ is drospirenone; estradiol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estradiol profile page.
US ANDA Litigation and Generic Entry Outlook for Angeliq
Angeliq was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 22, 2031. This may change due to patent challenges or generic licensing.
There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ANGELIQ
| International Patents: | 22 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ANGELIQ |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANGELIQ |
| DailyMed Link: | ANGELIQ at DailyMed |
Generic Entry Opportunity Date for ANGELIQ
Generic Entry Date for ANGELIQ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ANGELIQ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Brigham and Women's Hospital | Phase 4 |
| Bayer | N/A |
| Bayer | Phase 2 |
Recent Litigation for ANGELIQ
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bayer Schering Pharma AG v. Mylan Pharmaceuticals Inc. | 2011-04-19 |
| Bayer Schering Pharma AG v. Sun Pharmaceutical Industries, Inc. | 2011-01-12 |
| Bayer Schering Pharma AG v. Lupin Ltd. | 2010-07-15 |
Pharmacology for ANGELIQ
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
Paragraph IV (Patent) Challenges for ANGELIQ
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ANGELIQ | TABLET;ORAL | drospirenone; estradiol | 021355 | 2015-01-08 |
| ANGELIQ | TABLET;ORAL | drospirenone; estradiol | 021355 | 2007-12-26 |
US Patents and Regulatory Information for ANGELIQ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | ANGELIQ | drospirenone; estradiol | TABLET;ORAL | 021355-001 | Feb 29, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | ANGELIQ | drospirenone; estradiol | TABLET;ORAL | 021355-002 | Sep 28, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 ANGELIQ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | ANGELIQ | drospirenone; estradiol | TABLET;ORAL | 021355-002 | Sep 28, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANGELIQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I519300 | Start Trial |
| Brazil | 112012026115 | Start Trial |
| Australia | 2011240102 | Start Trial |
| China | 102985070 | Start Trial |
| Taiwan | 201204368 | Start Trial |
| Israel | 222353 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ANGELIQ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | 04C0022 | France | Start Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 0398460 | SPC/GB04/032 | United Kingdom | Start Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
