Pregabalin [(S)-3-(Aminomethyl)-5-methylhexanoic acid , Lyrica] 25, 50, 75, 100, 150, 200, 225, 300 mg/capsule: Innovator Pfizer sues 7 generic player

Innovator Pfizer in a bid to protect it’s blockbuster neuropathic pain treatment Pregabalin (Lyrica) against generic challenge has filed patent infringement suit against various generic players on April 29, 2009 in Delaware District Court.

The said lawsuit was filed in response to ANDA filed by various generic players on this product for Pregabalin (Lyrica) 25, 50, 75, 100, 150, 200, 225, 300 mg/capsule.

The generic players have filed Para IV against following Orange Book listed patent:

US5563175 (Expiry: Oct 8, 2013): Which covers A method of treating a patient having seizure disorders which comprises administering to said patient an effective amount of a substantially pure compound of the formula S-(+)-4-amino-3-(2-methylpropyl)butanoic acid.

US6001876 (Expiry: Dec 30, 2018): Which covers method of treatment of pain using (S)-3-(aminomethyl)-5-methylhexanoic acid and 3-aminomethyl-5-methyl-hexanoic acid.

US6197819 (Expiry: Dec 30, 2018): Which covers S-(+)-4-amino-3-(2-methylpropyl) butanoic acid as a single optical isomer as product.

Subsequently, innovator sued following 7 generic players for patent infringement:

1. Sun Pharma
2. Lupin
3. Wockhardt
4. Cobalt
5. Actavis
6. Sandoz
7. Alpharma (Mylan)

The above generic players have filed their ANDA on Dec 30, 2008, i.e earliest ANDA filing date, accordingly, these generic players will be eligible for lucrative 180 days generic exclusivity as per Hatch-Waxman provisions.

Possibly, generic players have filed ANDA with invalidation grounds against Orange Book listed patent.

Importantly, innovator has sued all generic players for the infringement of ‘819 patent (product patent). Additionally, innovator has sued Lupin for ‘175 and ‘876 patent.

Earlier, innovator got USFDA approval to market this product in 25, 50, 75, 100, 150, 200, 225, 300 mg/capsule on Dec 30, 2004.

Pregabalin is indicated for management of neuropathy pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and management of fibromyalgia

This product has achieved approximately 2.0 billion USD global sales in the year 2007 and future sale forecast for this product is quite bright.

New Paragraph IV filings reported by USFDA till April 23, 2009

Brimonidine Tartrate and Timolol Maleate 0.2%/0.5% Ophthalmic Solution (Combigan) Para IV filed on Nov 21, 2008

Capecitabine 150 mg and 500 mg Tablets (Xeloda). Para IV filed on Nov 10, 2008

Diclofenac Sodium and Misoprostol 75 mg/0.2 mg Delayed-release Tablets (Arthrotec) Para IV filed on Nov 28, 2008

Guaifenesin and Dextromethorphan 600 mg/30 mg and 1200 mg/60 mg Extended-release Tablets (Mucinex DM) Para IV filed on Dec 17, 2008

Lovastatin and Niacin 20 mg/750 mg Extended-release Tablets (Advicor) Para IV filed on Dec 17, 2008

Sevelamer Carbonate 800 mg tablets (Renvela) Renvela Para IV filed on Dec 4, 2008

Pregabalin (Lyrica) Capsules 25, 50, 75, 100, 150, 200, 225, and 300 mg Para IV filed on Dec 30, 2008

Ropinirole (Requip XL) Extended-release Tablets 4 mg and 8 mg Para IV filed on Oct 31, 2008 and Nov 3, 2008

Venlafaxine Hydrochloride (Venlafaxine hydrochloride) Tablets 37.5, 75, and 150 mg Para IV filed on Feb 12, 2009

Omega-3-acid ethyl esters (Lovaza) Capsules 1 g Para IV filed on Nov 10, 2008

Darifenacin (Enablex) Extended-release Tablets 7.5 and 15 mg Para IV filed on Dec 22, 2008

Doxycycline (Doryx) Delayed-release Tablets 150 mg Para IV filed on Dec19, 2008

Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol 0.15 mg/0.03 mg/0.01 mg Tablets (Seasonique) Para IV filed on Jan 22, 2008

(Source: USFDA)

Paragraph IV certification reported by USFDA from November 2008 till February 3, 2009

Carbidopa+ Levodopa + Entacapone (Stalevo) Tablets 12.5 mg, 50 mg and 200 mg 50 on August 5, 2008 and 50mg/200mg/200mg on Aug 28, 2008
Duloxetine (Cymbalta) Delayed-release Capsules 20 mg, 30 mg and 60 mg on Aug 4, 2008
Emtricitabine and Tenofovir Disoproxil (Truvada) Tablets 200 mg/300 mg on September 26, 2008
Fluticasone (Cutivate) Lotion 0.05% on July 28, 2008
Pramipexole (Mirapex) Tablets 0.75 mg on July 31, 2008
Zoledronic acid (Reclast) Injection 0.05 mg/mL, 100 mL vial n Aug 29, 2008
Clobetasol ( Clobex) Spray 0.05% on Septemeber 29, 2008
Desflurane (Suprane) Inhalation 99.9% on September 11, 2008
Fenofibrate (Antara) Capsules 43 mg and 130 mg on September 15, 2008
Lovastatin and Niacin (Advicor) Extended-release Tablets 20 mg/500 mg September 22, 2008
Olopatadine (Pataday) Ophthalmic Solution 0.2% on September 8, 2008
Tadalafil (Cialis) Tablets 2.5 mg on October 14, 2008
Testosterone (Testim) Gel 1% on October 21, 2008
Montelukast (Singular Granules) Oral Granules 4 mg on October 17, 2008
Paricalcitol (Zemplar) Capsules 1 mcg and 2 mcg on October 14, 2008
Risedronate (Actonel) Tablets 150 mg on October 8, 2008
Metformin Hydrochloride (Fortamet) 500 mg and 1000 mg Extended-release Tablets on October 14, 2008
Pemetrexed Disodium (Alimta)100 mg/vial For Injection July 1, 2008

Metformin (Fortamet) Extended-release Tablets 500 and 1000mg on October 14, 2008
Pemetrexed (Alimta) For Injection 100 mg/vial on July 1, 2008
Aprepitant (Emend) Capsule 40 mg, 80 mg and 125 mg on November 3, 2008
Bortezomib (Velcade) For Injection 3.5 mg/vial on November 20, 2008
Conjugated Estrogen (Synthetic A) (Cenestin) Tablet 1.25 mg on November 3, 2008
Epinastine (Elestat) Ophthalmic Solution 0.05% on October 14, 2008
Eptifibatide (Integrilin) Injection 2 mg/mL, 10 mL vial on September 30, 2008
Lanthanum (Fosrenol) Chewable Tablet 500 mg, 750 mg and 1000 mg on October 27, 2008
lopinavir and Ritonavir (Kaletra) Tablets 100 mg/25 mg and 200 mg/50 mg on December 23, 2008
Metronidazole (Metrogel) Topical Gel 1% on October 21, 2008
Minocycline (Solodyn) Extended-release Tablet 45 mg, 90 mg and 135 mg before Feb 5, 2009

Rropinirole (Requip XL) Extended-release Tablet 2 mg on October 14, 2008
Doxycycline Hyclate (Doryx) 75 mg and 100 mg before Feb 5, 2009

(Source: USFDA)