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Generated: July 22, 2017
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.| Patents: | 51 |
| Tradenames: | 57 |
| Ingredients: | 38 |
| NDAs: | 58 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | RX | Yes | Yes | 6,730,288 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bayer Hlthcare | STAXYN | vardenafil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 200179-001 | Jun 17, 2010 | RX | Yes | Yes | 8,613,950 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | AB | RX | Yes | No | 6,362,178 | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
Bayer Hlthcare | CIPRO XR | ciprofloxacin; ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473-001 | Dec 13, 2002 | DISCN | No | No | 7,709,022*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bayer Hlthcare | ULTRAVIST 370 | iopromide | INJECTABLE;INJECTION | 020220-001 | May 10, 1995 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO | ciprofloxacin | INJECTABLE;INJECTION | 019847-001 | Dec 26, 1990 | 4,705,789*PED | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | 5,569,652 | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | ULTRAVIST (PHARMACY BULK) | iopromide | INJECTABLE;INJECTION | 021425-002 | Sep 20, 2002 | 4,364,921 | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;IV (INFUSION) | 021277-001 | Nov 30, 2001 | 5,849,752 | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | 4,957,939 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
regorafenib | Tablets | 40 mg | STIVARGA | 9/27/2016 |
drospirenone and estradiol | Tablets | 0.25 mg/0.5 mg | ANGELIQ | 1/8/2015 |
sorafenib tosylate | Tablets | 200 mg | NEXAVAR | 2/28/2014 |
moxifloxacin hydrochloride | Injection | 1.6 mg/mL | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | 2/7/2014 |
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calcium | Tablets | 3 mg/0.02 mg/0.451 mg and 0.451 mg | BEYAZ | 11/13/2012 |
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calcium | Tablets | 3 mg/0.03 mg/0.451 mg and 0.451 mg | SAFYRAL | 9/28/2012 |
azelaic acid | Gel | 15% | FINACEA | 7/27/2012 |
vardenafil hydrochloride | Orally Disintegrating Tablets | 10 mg | STAXYN | 12/22/2011 |
drospirenone and ethinyl estradiol and levomefolate | Tablets | 3 mg/0.02 mg/0.451 mg and 0.451 mg | BEYAZ | 11/21/2011 |
desonide | Gel | 0.05% | DESONATE | 12/1/2010 |
estradiol valerate and dienogest | Tablets | 3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg | NATAZIA | 10/22/2010 |
ciprofloxacin | Oral Suspension | 250 mg/5 mL and 500 mg/ 5 mL | CIPRO | 10/16/2009 |
vardenafil hydrochloride | Tablets | 2.5 mg | LEVITRA | 9/4/2009 |
vardenafil | Tablets | 5 mg ad 10 mg | LEVITRA | 7/10/2009 |
vardenafil hydrochloride | Tablets | 20 mg | LEVITRA | 3/5/2009 |
drospirenone and estradiol | Tablets | 0.5 mg/1 mg | ANGELIQ | 12/26/2007 |
drospirenone and ethinyl estradiol | Tablets | 3 mg/0.02 mg | YAZ | 9/29/2006 |
estradiol | Transdermal System | 0.05 mg/day and 0.1 mg/day | CLIMARA | 9/12/2005 |
acarbose | Tablets | 25 mg, 50 mg and 100 mg | PRECOSE | 3/22/2005 |
drospirenone and ethinyl estradiol | Tablets | 3 mg/0.03 mg | YASMIN | 1/7/2005 |
| Patent Number | Expiration Date |
|---|---|
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,263,580 | Vitamin formulation | ► Subscribe | |||||||||||||||||||||||||||
| 8,703,105 | Oleaginous pharmaceutical and cosmetic foam | ► Subscribe | |||||||||||||||||||||||||||
| 9,492,412 | Penetrating pharmaceutical foam | ► Subscribe | |||||||||||||||||||||||||||
| 8,119,109 | Foamable compositions, kits and methods for hyperhidrosis | ► Subscribe | |||||||||||||||||||||||||||
| 9,592,245 | Very low-dosed solid oral dosage forms for HRT | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 201336 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 0013010 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 201204368 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 168399 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1330649 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00111 | Netherlands | ► Subscribe | PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621 | ||||||||||||||||||||||||||
| 2015000093 | Germany | ► Subscribe | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 | ||||||||||||||||||||||||||
| 0130034 00099 | Estonia | ► Subscribe | PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013 | ||||||||||||||||||||||||||
| 90034-4 | Sweden | ► Subscribe | PRODUCT NAME: RADIUM-223; REG. NO/DATE: EU/1/13/873 20131113 | ||||||||||||||||||||||||||
| 643 | Luxembourg | ► Subscribe | 91643, EXPIRES: 20211022 | ||||||||||||||||||||||||||
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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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