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Bayer Hlthcare Company Profile
What is the competitive landscape for BAYER HLTHCARE, and what generic alternatives to BAYER HLTHCARE drugs are available?
BAYER HLTHCARE has fifty-eight approved drugs.
There are forty-six US patents protecting BAYER HLTHCARE drugs.
Summary for Bayer Hlthcare
| US Patents: | 46 |
| Tradenames: | 57 |
| Ingredients: | 38 |
| NDAs: | 58 |
Drugs and US Patents for Bayer Hlthcare
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-004 | Oct 8, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | |||||
| Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;IV (INFUSION) | 021277-001 | Nov 30, 2001 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | |||||
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | RX | Yes | No | 8,841,446 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | Oct 8, 2013 | RX | Yes | No | 6,743,798 | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;IV (INFUSION) | 021277-001 | Nov 30, 2001 | DISCN | Yes | No | 6,548,079 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | |||||
| 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 Bayer Hlthcare
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | 6,133,251 | ➤ Sign Up |
| Bayer Hlthcare | MENOSTAR | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 021674-001 | Jun 8, 2004 | 5,223,261 | ➤ Sign Up |
| Bayer Hlthcare | EOVIST | gadoxetate disodium | SOLUTION;INTRAVENOUS | 022090-001 | Jul 3, 2008 | 5,798,092 | ➤ Sign Up |
| Bayer Hlthcare | PRECOSE | acarbose | TABLET;ORAL | 020482-004 | May 29, 1997 | 4,904,769 | ➤ Sign Up |
| Bayer Hlthcare | GADAVIST | gadobutrol | SOLUTION;INTRAVENOUS | 201277-001 | Mar 14, 2011 | 5,980,864 | ➤ Sign Up |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | 5,695,784*PED | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.5 mg, 1 mg,1.5 mg, 2 mg and2.5 mg | ➤ Subscribe | 2017-10-10 |
| ➤ Subscribe | Tablets | 0.25 mg/0.5 mg | ➤ Subscribe | 2015-01-08 |
| ➤ Subscribe | Tablets | 3 mg/0.02 mg/0.451 mg and 0.451 mg | ➤ Subscribe | 2012-11-13 |
| ➤ Subscribe | Tablets | 5 mg ad 10 mg | ➤ Subscribe | 2009-07-10 |
| ➤ Subscribe | Tablets | 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg | ➤ Subscribe | 2010-10-22 |
| ➤ Subscribe | Gel | 15% | ➤ Subscribe | 2012-07-27 |
| ➤ Subscribe | Tablets | 25 mg, 50 mg and 100 mg | ➤ Subscribe | 2005-03-22 |
| ➤ Subscribe | Transdermal System | 0.05 mg/day and 0.1 mg/day | ➤ Subscribe | 2005-09-12 |
| ➤ Subscribe | Tablets | 40 mg | ➤ Subscribe | 2016-09-27 |
| ➤ Subscribe | Gel | 0.05% | ➤ Subscribe | 2010-12-01 |
| ➤ Subscribe | Tablets | 3 mg/0.03 mg | ➤ Subscribe | 2005-01-07 |
| ➤ Subscribe | Orally Disintegrating Tablets | 10 mg | ➤ Subscribe | 2011-12-22 |
| ➤ Subscribe | Tablets | 0.5 mg/1 mg | ➤ Subscribe | 2007-12-26 |
| ➤ Subscribe | Tablets | 3 mg/0.02 mg/0.451 mg and 0.451 mg | ➤ Subscribe | 2011-11-21 |
| ➤ Subscribe | Tablets | 20 mg | ➤ Subscribe | 2009-03-05 |
| ➤ Subscribe | Tablets | 2.5 mg | ➤ Subscribe | 2009-09-04 |
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | 2014-02-28 |
| ➤ Subscribe | Topical Foam | 15% | ➤ Subscribe | 2017-09-14 |
| ➤ Subscribe | Tablets | 3 mg/0.03 mg/0.451 mg and 0.451 mg | ➤ Subscribe | 2012-09-28 |
| ➤ Subscribe | Oral Suspension | 250 mg/5 mL and 500 mg/ 5 mL | ➤ Subscribe | 2009-10-16 |
| ➤ Subscribe | Tablets | 3 mg/0.02 mg | ➤ Subscribe | 2006-09-29 |
| ➤ Subscribe | Injection | 1.6 mg/mL | ➤ Subscribe | 2014-02-07 |
Premature patent expirations for BAYER HLTHCARE
Non-Orange Book US Patents for Bayer Hlthcare
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,029,659 | Mousse composition | ➤ Sign Up |
| D791318 | Inserter | ➤ Sign Up |
| 7,928,239 | Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas | ➤ Sign Up |
| 9,320,705 | Sensation modifying topical composition foam | ➤ Sign Up |
| 8,263,580 | Vitamin formulation | ➤ Sign Up |
| 8,795,635 | Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Bayer Hlthcare Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Serbia | 52374 | ➤ Sign Up |
| Japan | 4777887 | ➤ Sign Up |
| South Korea | 101800041 | ➤ Sign Up |
| South Korea | 20060052866 | ➤ Sign Up |
| Germany | 19812462 | ➤ Sign Up |
| Australia | 2004321183 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Bayer Hlthcare Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| /2014 | Austria | ➤ Sign Up | PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331 |
| 2006 00038 | Denmark | ➤ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 156 | Luxembourg | ➤ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| C0005 | Belgium | ➤ Sign Up | PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711 |
| C/GB04/032 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 00182 | Netherlands | ➤ Sign Up | PRODUCT: GADOXETINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZONDER HET NATRIUMZOUT. FIRST AUTHORIZATION NO/DATE: 1829 AND 18930, 20040326 (SE); NATIONAL AUTHORIZATION NO/DATE: RVG 31393 AND 31394, 20050113 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
