DrugPatentWatch Database Preview
ANGELIQ Drug Profile
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.
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 |
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 |
Paragraph IV (Patent) Challenges for ANGELIQ
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.25 mg/0.5 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Tablets | 0.5 mg/1 mg | ➤ Subscribe | Start Trial |
International Patents for ANGELIQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2011240102 | Start Trial |
| South Korea | 20130097073 | Start Trial |
| Mexico | 2012012026 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011128336 | Start Trial |
| Japan | 2013523860 | 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 |
