Mylan Company Profile
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What is the competitive landscape for MYLAN, and what generic alternatives to MYLAN drugs are available?
MYLAN has seven hundred and thirty-six 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-seven supplementary protection certificates in eighteen countries.
Summary for Mylan
| International Patents: | 303 |
| US Patents: | 45 |
| Tradenames: | 513 |
| Ingredients: | 463 |
| NDAs: | 736 |
| 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 | LISDEXAMFETAMINE DIMESYLATE | lisdexamfetamine dimesylate | CAPSULE;ORAL | 202835-002 | Aug 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan | TAMSULOSIN HYDROCHLORIDE | tamsulosin hydrochloride | CAPSULE;ORAL | 090408-001 | Apr 27, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan | AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 076418-003 | Oct 3, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078789-003 | Jun 1, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan Institutional | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065371-001 | Nov 28, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Mylan | CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702-001 | May 3, 2013 | AB | 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 | DEMADEX | torsemide | TABLET;ORAL | 020136-003 | Aug 23, 1993 | RE34672 | ⤷ Try a Trial |
| Mylan Speciality Lp | ACCUNEB | albuterol sulfate | SOLUTION;INHALATION | 020949-002 | Apr 30, 2001 | 6,702,997 | ⤷ Try a Trial |
| Mylan | ENLON-PLUS | atropine sulfate; edrophonium chloride | INJECTABLE;INJECTION | 019678-001 | Nov 6, 1991 | 4,952,586 | ⤷ Try a Trial |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,516,741 | ⤷ Try a Trial |
| Mylan Speciality Lp | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997-001 | Mar 13, 2009 | 6,761,910 | ⤷ Try a Trial |
| Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | 7,470,433 | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | 5,866,591*PED | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Mylan Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112012000890 | ⤷ Try a Trial |
| Spain | 2637956 | ⤷ Try a Trial |
| Australia | 2004229512 | ⤷ Try a Trial |
| South Korea | 20070011370 | ⤷ Try a Trial |
| Japan | 2006522663 | ⤷ Try a Trial |
| New Zealand | 578674 | ⤷ Try a Trial |
| Singapore | 10201407913U | ⤷ 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 |
|---|---|---|---|---|
| 0253310 | C950009 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902 |
| 0193926 | SPC/GB98/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RIVASTIGMINE, AS FREE BASE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5427501 19970731; CH 5427502 19970731; CH 5427503 19970731; CH 5427504 19970731; CH 5427505 19970731; CH 5427506 19970731; UK EU/1/98/066/001 19980512; UK EU/1/98/066/002 19980512; UK EU/1/98/066/003 19980512; UK EU/1/98/066/004 19980512; UK EU/1/98/066/005 19980512; UK EU/1/98/066/006 19980512; UK EU/1/98/092/023 19980512; UK EU/1/98/092/024 19980512; UK EU/1/98/092/025 19980512; UK EU/1/98/092/026 19980512; UK EU/1/98/066/025 19980512; UK EU/1/98/066/026 19980512; UK EU/1/98/092/019 19980512; UK EU/1/98/092/020 19980512; UK EU/1/98/092/021 19980512; UK EU/1/98/092/022 19980512; UK EU/1/98/0 |
| 0780390 | PA2004012,C0780390 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309 |
| 2105135 | C300717 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805 |
| 1608344 | LUC00065 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824 |
| 1427415 | 11C0042 | France | ⤷ Try a Trial | PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520 |
| 0961612 | SZ 41/2009 | Austria | ⤷ Try a Trial | PRODUCT NAME: PACLITAXEL ALBUMIN |
| >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.
