Mylan Company Profile
✉ Email this page to a colleague
What is the competitive landscape for MYLAN, and what generic alternatives to MYLAN drugs are available?
MYLAN has seven hundred and thirty-eight approved drugs.
There are forty-five US patents protecting MYLAN drugs. There are forty-three tentative approvals on MYLAN drugs.
There are three hundred and three patent family members on MYLAN drugs in forty-two countries and one thousand one hundred and forty-six supplementary protection certificates in eighteen countries.
Summary for Mylan
| International Patents: | 303 |
| US Patents: | 45 |
| Tradenames: | 515 |
| Ingredients: | 465 |
| NDAs: | 738 |
| Patent Litigation for Mylan: | See patent lawsuits for Mylan |
| PTAB Cases with Mylan as petitioner: | See PTAB cases with Mylan as petitioner |
Drugs and US Patents for Mylan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 070213-005 | Apr 8, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | ELETRIPTAN HYDROBROMIDE | eletriptan hydrobromide | TABLET;ORAL | 205152-002 | Aug 11, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | PIROXICAM | piroxicam | CAPSULE;ORAL | 074043-002 | Sep 22, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Labs Ltd | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 076889-002 | Mar 25, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Asi | ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 090212-002 | Mar 28, 2014 | AP | RX | No | No | ⤷ 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 Mylan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-002 | Nov 19, 1996 | 5,886,039 | ⤷ Try a Trial |
| Mylan Spclt Viatris | DIPENTUM | olsalazine sodium | CAPSULE;ORAL | 019715-001 | Jul 31, 1990 | 4,559,330 | ⤷ Try a Trial |
| Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | 7,198,801 | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | 5,866,591*PED | ⤷ Try a Trial |
| Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | 7,470,433 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Foam | 0.12% | ➤ Subscribe | 2007-08-10 |
| ➤ Subscribe | CapsulesInhalation Solution | 0.02 mg/2 mL | ➤ Subscribe | 2009-01-21 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Nasal Spray | 0.125 mg base/spray | ➤ Subscribe | 2005-11-14 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Inhalation Solution | 0.021% and 0.042% | ➤ Subscribe | 2005-10-19 |
| ➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
| ➤ Subscribe | Foam | 2% | ➤ Subscribe | 2009-07-30 |
| ➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
| ➤ Subscribe | Topical Foam | 0.05% | ➤ Subscribe | 2005-06-27 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | for Injection | 1 mg/vial, 2 mg/vial and 5 mg/vial | ➤ Subscribe | 2013-12-27 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Ophthalmic Solution | 0.05% | ➤ Subscribe | 2006-12-13 |
| ➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
| ➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
International Patents for Mylan Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2016026214 | ⤷ Try a Trial |
| Eurasian Patent Organization | 200701259 | ⤷ Try a Trial |
| Cyprus | 1109196 | ⤷ Try a Trial |
| Morocco | 27285 | ⤷ Try a Trial |
| Canada | 2989129 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Mylan Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | C01730131/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
| 1261586 | 15/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124 |
| 0443983 | C300445 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| 3150586 | 2020C/515 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
| 2506844 | 2018C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
